Note : Les descriptions sont présentées dans la langue officielle dans laquelle elles ont été soumises.
Teehnical Fie Zd
Dressings are regularly used to cover open wounds
~ e~ is
and burns. ~ffYff~h~ an ever-present need for non-allergenic
antibacterial and antifungal compositions which have superior
healing properti~s and permit the covering of such wounds ox
burns wit~out having healing tissue grow into gauze or similar
material .
Backgrou~%d Ar~
For more ~han two years prior to the subject
invention free sugar had been used on wounds either as a
single constituent or in conjunction with povidone-iodine
(BPtadine solutlon). During this period sugar was poured
directly into the wound ~if the wound was deep), a 4 -inch
~10.16 centimeters~ by 4~inch sponge or other dressing
material was soaked in Betadine~ solution and used to dress
the wound and the dre55ing was changed at intervals of from
6 to 8 hours;~shallow ~ounds were aressed wi~h Betadine~
sol~tion-soaked sponges which were then coated with
approximately 0.~5 inch (0.635 centimeter) of sugar and
ap~lied face down (sugar in dixect con~act with the wound)
~o the wound.
Nokwithstanding handling difficulties and lack o~
control or unifoxmity, wo~nd-healing time was markedly
reduced in this manner~ In more than 300 cases such use
of povidone-iodine solution in conjunction wi~h sugar pro~ed
6~ .
.
to be a safe, reliable and rapid method for healing of a
variety of wounds. These wounds included ~oth clean and
infected, fresh and old wounds. Their variety extended
from simple abrasions and lacerations to massive soft tissue
trauma, including burns, crush injuries, shot-gun and gun
shot wounds; decubitus, diabetic and stasis ulcers; and
exposed, fractured bone.
In massi~e soft tissue injuries ~such as shot-gun
wounds and second- or third-degree burns) debridemen;wQs
essential as in routine wound c~re. Thereaf~er, repeated
.. .. . . . . . .
~ d.ressing changes with sugar and povidone-iodine solution
were found to produce a clean, granulating.wound in rapid
fashion, with no production of eschar and no superficial
: in~ection, despite the absence of systemic antibiotics.
Surprisingly, this treatment produced large amounts
of granulation tissue in ~uant.Lties sufficient to fill in
: larse soft-tissue defects secondary to the original wound.
Skin rather xapidly covered the new, exuberant granulation
tissue spontaneously, thereby largely reducing healing time
~ . and the necessity for skin grafting.
;` Regeneration of ti~sue, rather ~han retraction o.
~: the wound, was the general rule. In many cases the healed
: wound was so~t and resilient, with good sensation.
:; There is good e~idence to suggest that sugar
produ~ts, such as honey and molasses, were used in treating
: wounds, including burns, in ancient times. Evidence suggests
that the native American Indians from Canada to the Inca
`
--3--
Empire were adept in the use of a number of medicinal compounds
which showed considerable promise in the treatment of wounds and
burns. These included herbs, root extracts, leaf extracts and
varieties of maple syrup, sorghum, molasses, honey and eventually
sugar (as sugar cane). In ancient Egypt, preservation of food
and treatment of wounds included the use of sugar products.
Povidone-iodine (polyvinylpyrrolidone-iodine complex)
is a topical anti~infective ("The Merck Index", ninth edition,
pages 996 and 997, entry 7499, Merck & Co., Inc., 1976) which is
commercially available in a number of forms, e.g. Betadine ~
aniseptic gauze pad, solution, solution swab aid, aerosol spray,
surgical scrub, douchej vaginal gel, skin cleanser, ointment,
`~ microbicidal bath, perineal wash and whirlpool concentrate
[Physicians' Desk Reference" (PDR), 31st edition, pages 1263 to
1265, 1977].
Invention
An admixture (hereafter: the subject composition of
a) an antifun~al/antibacterial agent, such as povidone-iodine,
~ b) an antibacterial tissue nourisher, e.g. sugar (which is, per
- 20 se, a strong antibacterial agent in high concentrations and
functions as a stimulant to the growth of granulation tissue)
and c) a suitable carrier, in appropriate proportions, provides
a stable effective antibiotic composition which facilitates
healing wounds to which it is directly applied, prevents growth
of granular tissue into covering dressing and otherwise satisfies
the hereinafter-recited objectives~
Thus, in a first`aspect, this invention provides a
s substantially-homogeneous therapeutically-acceptable antimicrob-
ial admixture of:
a) from 10 to 80 parts by weight of an antibacterial tissue
nourisher,
b) 1 part by weight of effective antifungal/antibacterial agent
-- 4 --
:, ~
.~,
means which is physically, chemically and pharmacologically
compatible with (a), and
c) a sufficient amount of carrier means to impart to the
admixture a consistency which readily permits it to be spread
on and adhere to a sponge or gauze dressing and to remain in
place when applied directly to tissue of an open wound or of a
burn, the carrier means being physically, chemically and pharma-
olgically compatible with both (a) and (b) and comprising at
most one third of the weight of said admixture.
In a second aspect this invention provides a process
of preparing a substantially-homogeneous therapeutically-accept-
able admixture which comprises mixing together or in any order:
a) from 10 to 80 parts by weight of an antiba`cterial tissue
nourisher,
b) 1 part by weight of effective antifungal/antibacterial agent
which is physically, chemically and pharmacologically compatible
with the antibacterial tissue nourisher (à), and
c) a sufficient amount of carrier which imparts to the admixture
: -
a consistency which readily permits it to be spread on and to
~0 adhere to a sponge or gauze dressing and to remain in place when
applied directly to tissue of an open wound or oE a burn, the
carrier bei`ng physcially, chemically and pharmacologically com-
patible with both the antibacterial tissue nourisher (a) and the
antiEungal/antibacterial agent (b) and comprising at most one
.,.
third oE the weight of said admixture.
.; ~ .
$~ -~ The antifungal/antihacterial agen-t is any such agent
which is compatible with sugar. It is advantageously water
soluble for ease of handling and for removal Erom
;
~ - 4a -
. .
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tissue being treated. It is preferably non-allergenic so
that it might have a wider scope o applicability~ Povidone-
iodine satisfies all of these criteria, is the antifungal/anti-
bacterial ag~nt of choice and is thus used throughout the
disclosure in pxovided examples. Any other antifungal/anti-
bacterial agent that is compatible with sugar and is thera-
peutically acceptable for administration directly to open
wounds is alternatively combined with a sugar, e.g. sucrose,
dextrose, maltose, fructose, honey and molasses, in the
same or comparable manner.
Povidone-iodine is c:onveniently provided in the
~orm of Betadine ointment (10 percent povidone-iodine) and
Betadine solution ~10 percent: povidone-iodine), since these
are in suitable carrier and no further carrier is required.
; Alternatively, the antifungal/~antibacterial agent is
separately combined with sugar~ any (preferably) water-
soluble and substantially-inert ~hysiologically-accepta~le
ointment base, e~g. Unibase , and, optionally, water (to
~` make more fluid) or, e.g., carboxymethylcellulose t~o make
less fluid) to obtain an appropriate consistency and stabi-
liky. Nat~l~ally, other ointment bases, such as petroleum
jelly, axe similarly useful i~ water-solubility is not
required.
;~ Ths sugar is suita~ly in the form purchased at
; a~y grocery store; it need not be specially puxified,
sterilized or otherwise treated. Although sucrose is pr~-
~ ferred in ~iew of its low cost and availability, such can
.: ~
.
-5-
s~ ~
be partially or wholly replaced by dextrosP~ maltose, fruc-
tose, honey, molasses or similar high-sugar-content substance.
All references herein to su~ar optionally include ~indivi-
dually or in any combination) each of the preceding;.all
examples~ however, are based on common, ordinary granulated
sugar.
The ratio of sugar to, e.g., po~idone-iodine~ is
significant from the viewpoint of costy ease of handling
and effecti~eness. ~en the povidone-iodine is in the form
o Betadiine ointment and Betadine solution, the weight
ratio of sugar to_Betadine. ointment acceptably.~arie~ from
1:1 to 8:1, with the amount of Betadine solution gradually
~ increasing from zero for the 1:1 ratio to 0.5 ounce per
'. ~ . pound ~0.03125 ~ram per gram) for the 2.5:1 ratio to
1 ounce per pound for the 4:1 ratio to 2 ounces per pound
for the 8:1 ratio ~based on the ~otal weight of sugar and
Betadine ointment).
. For extended shelf lif~, the range is advan~a-
~: geously limited to 2.5:1 to 5:1. Below that range (from
1:1 to 2.5:1) the components tend to separate but are readily
redispersed by stirxing shortly before use; above that
.~ range ~from 5:1 to 8:1) the components tend to separate
and crystallization occurs.
The preferred formulation is that based on 20 parts
by weight of sugar ~sucrose), 5 parts by weigh~ of Betadine~
oinb~ent and 2 parts by weight of Betadine~ solution. This
correspor~s to l~0 parts by ~eight_of sugar~ 3_5-par~s by.
.~ .
.~ .
~ 6
.,
/
~ ~5~
weight of povidone-iodine and 31.5 parts by weight of
carrier. ~hen the components are mixed in these proportions,
~he resulting admixture holds together and maintains its
consistency in ~oth heat and cold for long shelf life; it
is easy to apply and has hiyh patient acceptance. In addi-
tion, these amounts have been arrived a~ through experimen-
tation with various proportions of the respective components;
these proportions have been found to be the most useful,
not only for the compounding of this mixtur~, but for the
efficacy of the product in terms of various wounds and treat-
ments for which it has been employed. -That ~s to say, a --
proportion o sugar approximating 70 to 80 percent by
weight (based on total composition weight) appears to be
the optimum for wound healing., This corresponds closely
; with the concentration of sugars in honey.
` Ob~ ectiues ~~
~; 1. To provide comp~sition which inhibits the
~; growth and proliferation of ana kills bacteria and fungi
`~ which it contacts~
2. To provide a microbicidal and antibiotic
composition which will, when employed as a wound dxessing,
i ` result i~ a clean ~ebrided wound.
3 - - 3~ To provide a composition having a consistency
whi h facilitates its use directly on and in conjunction
with the dressing of open wounds and burns.
~ .
~; ~7~
.~
.
~'5~
4. To proviae a composition which is stable
(shelf-life and temperature) against separation or crystalli-
zation or is at least susceptible to controlled application,
e.g., by stirring shortly be~orP use.
5. To provide a composition which cleans tissue
it contacts so that the tissue can present a bed for orming
granula~ion tissue.
6. To pro~ide a composition w~ich encourages
formation of exuberant granulation tissue in a clean environ-
ment O
7. To provide a composition which encouragesepi~helialization from the edges of a wound while granula-
tion tissue fills the defect without eschar.
; 8. To provide a composition which enables a wound
to be covered by s~in with little or no defect.
., . ~
9. To provide a single composition which serves
as a) an antibiotic and antifungal agent, b) food and
.~ .
nourishment ~or granulation tissue and c) encouragement for
~i skin coverage.
¦ ~ 10. To provide a composition whi~h serves as a
topical anesthetic, reducing the need for narcotics.
11. To provide a composition which reduces or
, eliminates growth of wound tissue (to which it is applied)
into gauze or similar covering material.
12. To provide a composition which encourages
- tissue regeneration.
;~ . .
, 13. To provide a water-soluble and water-washable
..
; .
~ -8-
,
:
4 ~ antimicrobial.product which has a smooth to slightly granular
texture, is airectly applicable to wounds and burns, aci-
litates rapid healing with minimal scarring, readily adheres
to dressings and prevents growth of granular tissue into the
dressing.
14. To provide an economical composition whîch is
effe tive in treating a full spectrum of wounds incurred by
man and other animals.
. 15. To provide a unitary composition which is
portable as such;.and~need not be applied as separate compo~ -
nents to a wound or to dressing material.
: 16. To provide a me~dicament composition which is
dire~tly applicable to a wounded tissue and i5 stable
thareon when so applied.
17. To provide a medicament composition which is
easy to apply either directly to wounded tissue or to a
dressing material without spillage or creatin~ any mess.
18. To provide a medicament composition which
~ is substantially uniform and consistent thro~ghout and which
:~ is thus administrable by a readily-followed specified
- ~echnique which leads to predictable results.
:~ 19. To provide a substantially non~drying medi
cament composition which does not harden and adhere strongly
to wounded tissue to which it is applied.
20~ To provide a medicament composition with a
consistency which makes it easy to handle; it neither
crumbles (flakes off) nor flows, but it does hold together.
5~
210 To provide a substantially homogeneous compo-
sition ~or treating burns and open wounds and which has a
high degree of patient acceptability~
22. To provide a medicament composition which
stays in place when applied directly to wounded tissue nd
.is readily removable at a later time without injuring such
tissue.
: 23. To provide an open-wound-treating composition
whi~h mai.~tains long-lasting cleansing and healing properties
in situ and thus minimizes the frPquency of needed dressing
changes~
24. To provide a smooth and soothing medicament
composition with minimal, if any, irritation to wounded
tissue to which it is applied.
25. To provide a me:dicament composition which
permits complete and uniform c:overage of wounded tissue.
26. To pro~ide a composition which impaxts a
cooling sensation to and an anesthetic effect on wounded
tissue to which it is applied.
27. To provide a ~omposition which ena~les the
placement of uniform and controlled amounts of a sugar
; substance and of an antifungal/antibacterial in direct
contact with wounded tissue; the contact i5 predictable and
constant with regard to both of these component~.
28. To provide a wound-healing composition which
promotes the formation of healing tissue as firm granulation
tissue which ~ontinues to build up and to become the surface
tissue as the wound heals.
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,
s~
29. To provide a wound-treating composition which
is an improve~ debrider and reduces eschar formation.
30. To provide a wound-treating composition which
is easily applied by patients with minimal instruction.
31. To provide a composition with which patients
are willing to redress wounds as required.
32. To provide a wound-treating composition which
re~ders wounds substantially odorless.
33. To provide a wound-treating composition which
is readily and effectively applied without need for observing
...... ,, ,, ~ ., . ~ ,
"sterile" conditions, thus ~aterially reducing the cost of
dxessing and associated materials and the time required to
apply and to change dressings.
Components or Ingredients
~ lthough repeated reference is made to sugar or
sucrose, to povidone-iodine and to carrier used in Betadine~
ointment and in Betadine~ solution, these are merely illus-
trative of preferred embodiments; ,he subject invention is
~ot so limited.
In lieu of sucrose, any strong an~ibacterial (in
high concentration) agent which functions as a stimulant to
the srowth of granulation tissue, including other sugars
and sugar-provlding componen s~ such as fructose, glucose,
dextrose, maltose, honey, molasses or any combination ~hereo~,
is suitable. Ordinary table susar is preferred in ~iew of
its availability and cost. When honey, molasses or simi-
larly~fluid material ~s employed in plac2 of susar, the ~nt o~
~ 5~
separate carrier is optionally reduced or even eliminated.
This component is referred to, generically, merely as
nsugar" throughout most of this text.
Likewise, the subject compositions are not limited
to those wherein povidone-iodine is the antifungalJanti-
~acterial component~ Such component is replaced wholly or
partially by one or more different ingredients with similar
andJor related p~o~erties. The ingredient is, optionally,
insoluble or mPrely dispersible in water, but is preferably
water soluble; it may ber but is preferably not,an anti-
biotic; ideally, it is not allergenic. Illustxative of the
ingredients which comprise thîs component, in whole or in
part, are:
acrisorcin gentian violet nitrofurazene
Amphotericin B Griseoful~in Nys~atin
anthra~in haloprogin povidone-iodine
Candicidin hexachlorophene resorcinol
dibromopropamidine ichth~mo~ sulfabromometh2z~
isethionate
domiphen bromide iodochlorhydroxyquin undecylenic acid
fluorouracil iodoform zinc undecylenate
I~ order to provide the combination of the n sugar n
and ~he antifungal/antibacterial component with the desixed
consiste~cy, one or a combination of carriers is ordinarily
require~ Ingredients ~rom which ~he carrier is formulated
in any suitable combination include, e.g.:
.
12-
5650
agax polyethylene glycol 4000
cold cream polyethylene glycol 6000
corn oil povidone
cottonseed oil propylene glycol
gelatin silica gel
glyceri~ sodium alginate
hydrophilic ointment sodium carboxymethylcellulose
hydrophilic petrolatum sorbitol solution
lanolin . spermaceti
methylcellulose starch
olive oil . ~ . . stearic acid
peanut oil ~stearyl alcohol
pectin white ointment
polyethylene glycol 400 . white petrolatum
polyethylene glycol 600 ~yellow ointment
polyethylene glycol 1500
.
These are stanaard and recognized ingredients regularly
used in the formulation of topical ointments and salves.
They are used in the normal fashion and are admixed with the
"sugar" component to obtain a composition which does not flow,
but has the desired spreadable consistency and sufficient
adherence to hold it together. The composition advanta-
geously does not comprise one or more volatile components,
the loss of which (e~g. on leaving a jar of the composition
uncovered) would lead to a change in the consistency of such
composition.
-13-
~ he antifungal/antibacterial component must
necessarily be physically, chemically and pharmacologically
compatible with the "sugar" or sugar-providing component.
When a separate carrier component is used, it must also
be physically, chemically and pharmacologically compatible
with both of the pre~iously-noted essential components~
D~taiZs and ExampZes
The compositions of this invention provide a signi-
ficant improvement over prior administration of sugar and
Betadine solution, not only in terms of patient acceptabi-
lity and ease of application to various wounds, but also in
terms of the function of the product itself~ Prior to the
introduction of the compounded mixture, it was noted that
wounas would grow so rapidly tX~at they would have a tendency
to adhere to the dressing material and, therefore, wound
healing was distuxbed when the dxessing was changed. By
using povidone-iodine ointment in admixture with sugar, this
problem was eliminated. The careful admixture of the various
componen~s was worked out ovex a period of time in oxder to
achieve the present formulation, which has been found, on
repeated testing, to be extremely efficacicus and safe. It
has been success~ully used in a variety of treatment reglmens,
both operative and non-operative, and in a variety of wound
situations i~ the office, in physical therapy and in the
hospital setting. In many cases it has been founa to be
totally effective in the healing o~ a variety of wounds
without the use of further surgery~ skin grafting or ancil-
lary antibiotics.
~ 5~ '
A particular problem ~ncountered with the prior
treatment regimen (sugar in conjunction with Betadine
solution),rlore fre~uently in treating finger-tip amputations
than in treating deep wounds~involved the healing of fi~ger-
tip wounds at such a rapid rate that granulation tissue
tended to invade the dressing material. This posed some
considerable difficulty in removing the dressing nd, often,
a considerable amount of pain for the patient. Although
tightly-woven silk or nylon dressings would prevent this
problem, they also tended to limit the extent of granulation
tissue expansion and thereby tended to prevent the resulting
healed wound from res~oration to the preinjured stater
The admixture of sugar with povidone-iodine oint-
ment not only provided improvement by minimizing tissue growth
into dressing material while retaining the positive proper-
ties of susar and Betadine~ solution, it was also easier to
apply and uni~orm in consiste~cy. The separate components
were subject to various techniques of administration.
Spillage of Betadine colution and free sugar occurred
during application, making a general mess. After application
the separate components tended to dxy out; the sugar crystal-
liz~d and tended to escape from or through the dressing.
Numerous attempts were made to formulate a concoc-
tion of sugax with povidone iodine that would adhere to a
bandage and would not flow ~rom tissue or through dressings
to which it was applied, that was not generally sloppy to
' .
~5~
handle and did not result in a sticky, syrup-filled dressing.
Any admixture tended to reduce the amount of sugar placed in
direct contact with the wound. Premixed combinations of
sugar with povidone-iodine solutions separated after standins
for even a short period of time; the sugar settling at the
bottom and a syrup of povidone-iodine solution and sugar
layering at the topO Even using povidone-iodine ointment,
compositions having at least ~0 percent by weight of ointment
separated and were rather gooey, whereas a composition having in
excess of 80 percent by weight of sugar tended to become
granular and non-adherent to itself; it was difficult to
apply or to ~eep adhered to a dressing. A sugar : povidone~
iodine ratio o~ 3.5:0.1 to 4:0.1 proved best with the povi-
done-iodine in the form of 10 parcent (by weight) oin~ment.
This range combines optimum wound healing with both safety
and economy.
The preceding-ranges and proportions are predicated
on the admixture of sugar with different combinations of
Bet~dine ointment and Betadine solution, since these
povidone-ioaine products are readily a~ailable. When the
spec~fic composition prepared with 20 parts by weight of
sugax, 5 parts by weight o~ Betadine oin~ment and 2 parts
by weight of Betadine~ solution is aamixed so that it is
subs~antially uniform, it is ex~remely effectivef is
economical and i5 both shel-life and temperature stable.
~ The resulting proportion (20 0.7~ of sugar to povidone-
; iodine is truly limited only by the ~ctual nature
(consistency) of the carriers used for Betadine oin~ment
and Betadine solution. Other carriers ~used singly or in
appropriate combinations) produce comparably-stable admix-
tures ha~ing sugar/povidone-iodine weight ratios from 10:1
to 80~1 or, preferably, from 25:1 to 55:1. As povidone-
iodine is water soluble, water-soluble carriers are clearly
preferred, but not essential. The ke~ i5 the consistency of
~he sugar/carrier aamixture. When such consistency approxi-
mates that of the noted substantially uniform specific
composition, a suitable amount of povidone-iodine is incor-
porated therein to produce a homogeneous admixture having
the desired weight ratio of sugar to povidone-iodine. A
carxier is selected 50 that sugar constitutes two third~
or more of the sugar/povidone-iodine final product (~ncludlng
carrier) in order to provide a desired sugar concentration
in direct contact with tissue to which the meaication is
applied. By selecting water-soluble carriers with different
consistencies, varying concentrations of sugar are incor ~,
porated therein to o~tain stable sugar/carrier admixtures.
The addition of contemplated amounts of povidone-iodine ~o
a stable sugarJcarrier admixturç does not materially affect
either the consistency or the stability of the admixtuxe.
Suitable pharmacologically-acceptable water-
solubl~ carriers are known, and their particular selection
or combination is not the essence o~ the subject in~ention~
The same carriers that are used in Betadine ointment and
Betadine solution are optionally used with greater or lesser
-17
~S~5~ ~
concentrations of po~idone-iodine. Were the povidone-iodine
concPntration increased to 20 weight percent in each, the
resulting composition (corresponding to the noted specific
composition) would have a susar/povidone-iodine weight ratio
of 20:1~4; were it reduced to 5 weight percent ir. each, the
resulting composition would have a sugar~povidone-iodine
weight ratio of 20:0~35.
. For any sugar/carrier admixture that is too flui~,
a small proportion of a suitable stif~ening agent, such as
carboxymethylcellulose, is suitably addea. Agents of this
type also add to the stability of the aamixture.
Although a stable homogeneous admixture is pre-
r~rred and is herein taught, less-stable admixtures provide
many of the same ~dvantages and most of ~he same therapeutic
propexties so long as a high concentration o~ sugar i5 in
contact with the wound surface. If the compositions a) can
be mixed to a substantially uniform consistency shortly before
use, b) will adhere to gauze or similar material and c) will
stay in place on a wound to which they are applied, they are
clearly within the scope of this i~vention even though they
might tend to layer within hours if stored in a receptacle.
ha~ bee~
p~ Close watch ~s~ maintained to assure the com-
~1~ pounding i~ clean facilities and with clean e~uipment. A
; - stainless steel mixer and stainless steel blade are recom-
mended. The product i5 packaged in opaque, dishwasher-
cleaned, air-tight plastic containers.
To compound the mixture, e.g~, 2 pounds of povidone-
iodine solution tlO percent ~y weight), such as Betadine
solution, and 5 pounds of povidone-iodine ointment tlO percent `
- by weight), such as Betadine ointment, are placed in a
~18-
,
- \ r
;5~,
S-gallon stainless steel tub. Th~se are mixed well with a
stainless steel blade, powered by a one-half horsepower
motox, geaxed through a reduction gear designed for pizza
dough. ~en the mixture is uniform in consistency, 20
: pounds of sugar are added slowly until the mixed batch is
of unifo~m consistency.
The hardware and mixing apparatus are o stainless
steal to minimize any contamination of the product by soft~r
metals, such as aluminum. All u~ensils, including the mixing
bowl and blade, the stainless steel spoon and the container
jars,_are washed with soap ancl water prior to use.
~en the mixture is of uniform consistency ~usually
after l0 minutes of mixing), 1:he batch is weighed out into
~ . clean one-pint plastic containers tiars). These are opaque.
: Once weighed, the jars are closed tightly and labeled with
a batch number, corresponding to the date mixed. This pro-
duct, thus stored, maintains its consistency over a period
.
in excess of six months.
There are two basic technigues for applying the
admixtuxe to wounds. When the wound is deep, the medicine
is spread dire~tly onto the wound and then covered with a
standard 4 x 4 tinch) dressin~ pad or other appropriate
dressing material. The subject sugar/povi~one-iodine
admixtur~ adheres to the wound, making it easy to apply ~he
dressing. The more ~ommon techniyue is to apply thi.~
admixture directly on~o a 4 x 4 (inch) pad as if spreading
peanut butter on a slice o~ breadr The pad is then placed
o~er the wound with the medicine-side down. This approach
works better when applying ~ressings to ~urns and other
shallow wounds.
--lg--
~2~5~ '
That is to say, the medicine is applied to a
wound so a~ to cover the injured surface completely, gener-
ally with one-quarter-inch thickness of the medicine.
Dressing-change schedules are dictated by the conaition of
the wound. In highly-contaminated (pussy) or weeping wounds
dressing changes are perfonmed every four to six hours; in
other wounds dressing changes are performed less fre~uently~
sometimes only one or two times per d~y.
Dressings are ad~antageously changed three to
four times a ~ay. Since there seems to be more rapid develop-
ment of tissue in finger tiP . am~utations, he dressings
should be changed somewhat more frequently. ~i~h each
dressing removal, the residue is easily washed off with tap
5/1~ water or in a whirlpool, if ~ In approxi~ately 50 per-
cent of the cases hydrogen peroxide is useful for cleansing
the wound before debridement, and may be necessary as often
as once each day in many wounds.
The sugarfpovidone-iodine composition tends to
enhance---woun~ bleeding when applied to bleeding wounds
within twenty-four hours after injury. ~or;th-s reason~
after cleansing or debridement, Iodoform is generally used
initially to secure hemostasis in these wounds and the
composition is not applied until the following day or until
hemos~asis is assured~ Once the wound is free of bleeding,
the subject admixture is applied as previously described
with multiple daily dressing changes.
-20~
L.2t~
When epithelialization occurs, a ring of whitP
tissue sometimes appears between advancing skin and granu-
lation tissue. This is usually debrided one to two times
a day in order to obtain full skin coverage without allowing -
an indentation (defect) to occur at the site o the wound.
Repeated daily dressing changes are continued
until ~he wound is healedO ~ealing time varies, depending
upon the type and dep~h of the wound, but all thus-treated
wounds have healed well and relati~ely quickly.
SugardyneTM.h-~.been use ~ ~on a;variety.of wounds,=.. ....
both infected and non-inected~ In~ected wounds have been
contaminated with 5~ophy~ococcus oureus, ~. coZi, a~d Ps~monas
: aerugino5e, as well as these in combination, plus numerous
other bacterial species. Successully-treated wounds have
included abrasions, older lace.rations and shotgun and gunshot
wounds invol~ing both small an~ massive soft tissue injuries
and open fractures secondary to these injuries. Other
.
trea~ed injuries have included spider bites involving necro-
sis, irst-, second- and thira-degree burns; frostbite
injuries; open fractures tQ bone; and decubitus, pressure,
diabetic and stasis ulcers. The subject composition has not
been found successful i~ treating poison i~y and poison oak
unless the patient has exroriated the adjacent skin and it
has become infected.
.
--2~L--
5~
Some success has been experienced on psoriasis;
there is a tendency for healing of the psoriatic lesions.
On a massive fungating carcinoma o the skin in a 98 year
old patient, it caused a rapid decrease in the size of the
fungating lesion.
The composition has bee~ proved to be extremely
effective in the treatment of a large variety of common and
rather uncommon wounds to man where bacterial and fungal
contamination ordinarily occur. There has been an extremely
high success rate with rapid healing, minimization of hospi-
tal in-patient time and burn-unit time, and more rapid
-patient discharge. There has been a considerable improvement
in the end results because of more rapid healing and the
elimination o~ further surgical procedures, including ~kin
grafting.
In ~hose cases where grafting has been required,
the do~or sites have been treated with ~he composition.
These sites have healed without scarring and became barely
:
p rceptible, i~ at all, as donor sit~s.
;- The composition has not only presented itself as
an effective healing agent but, because of its anesthetic
effects, has significantly reduced the necessity ~or admini-
stering addictive narcotics. Where many patients would
normally request a narcotic medication prior to ox following
dressing changes, these requests have been at a minim~m when
using the composition. This is par~icularly true where
patients have large open wounds, including painful burns
-22-
~3 ~5~
where application of any topical medicine is extremely
disagreeable. Therefore, in addition to its wound-healing
properties, treatment with the composition has helped to
reduce addictive potential for narcotics, especially in
patients txeated over an extended period of time.
To a large extent thus-treated wounds have healed
with no scars or with minimal scarring. The wounded area
was left with skin that w s normally colored and sensitive,
and there has been no recurrence of ine~tions or produc-
tion of osteomyelitis in any patient treated to date. Inma~y cases an~ibiotics have been used minimally or not at
all in conjunction with this medicine. In many cases the
treated wounds have been among the worst seen by the inven-
tor, and they have healed well~ Moreover, even with dee~
wounds, hair has appeared on healed surface tissue. Regard-
less of bacterial or fungal contamination, the wounds have
sucessfully healed. This was true evPn where all other
employed products ailed and where a~l tried antibiotics
were found to be ineffec~ive. This was true using the
admixture in an "unsterile" form and applying it without
ol,s~n/inc
a~eæ~im - '7sterile" procedures.
~ he subject composition ~sugar~povidone-iodine
admixture) is an effective medicine which has been used and
is useful in ~he treatment ofo
_~3_
s~
1. ~brasions (infected and non-infected)
2. Absesses (~oils3
3. Acne (in~ected and non-infected)
4. Burns tinfec~ed and non-infected)
a~ Common burns
1. First degree
2. Second degree
3. Third degree
b. Other burns
: - 1. Electrical
2. Che~ical (acid, alkali and others)
3.~ Friction (rope and pavement~
;~ 4. Sunburn
5. Carbuncles (closed and draining)
`~ 6. Carcinoma of skin (in~ected and non infected)
7. Crush injuries--Reduction of tissue edema
8. Debriding agent in tissue necrosis
(Brown Recluse spider bites) (infected or
non-infected)
.. Deep wounds (infected and non-infected) ! ~-
; 10. Erysipelas
~ 11. Exposed bone ~infected or non-infected)
: ~ 12. Felon tonly after incision and drainage)
~: 13. Finger tip amputations ~large and small)
(inected or non-infected)
14. Fractur blisters ~in~ee~ed or non-infec~ed)
; 1~. Frostbite (infected or non-inected)
;''` . '
.... .
-24-
-`` l
~'5~
16. Gangrene (infected or non-infected)
17. Gunshot wounas (înfected or non-infected)
18. Lacerations (infected and non-in~ected)
190 Open wounds to bone (infected a~d non-infected)
20. Osteomyelitis
21. Paronychia tbefore and after incision and
drainage~
~2. Perianal abce~ses
~3. Pilonidal cysts tinfected or non-infeGted)
24. Post-op dressing (infected or non-infected)
25. Psoriatic lesions
26. Shotgun wounds ~infected or non-infected)
; 27. S~itch abcesses
28. Stump wounds and guillotine amputations
(infected or non-inected)
29. Ulcers ~infected or non-infected3
a. Decubitus (bed sores)
~ ~ - -b. Diabetic
:~ c. Pressuré
d.- Stasis ltrop~lc~ ~ ~--~~`-~~ ~~ --- -
To date no attempt at the treatment of eye, ear,
nose~ throat~or genital injuries has been made, and the
~ subject compositio~ has sho~n no significant effectiveness
`~ in the treatment ~f viral disea es, poison ivy or poison oak~
However, it has ~een effective in the treatment of all
wounds, whether co~taminated by bacteria, by fungi or by a
combination o~ bo~h. It has been found equally effectiYe
against both Gram-po5itive and Gram-negative bacteria.
,
2~
The medicine [a su~stantially homogeneous admix-
ture o-f from 10 to 80 parts by weight of a suitable sugar
(antibacterial tissue nourisher) or sugar-providing
component, 1 part by weight of a physically-, pharmacologi-
cally- and chemically~compatible antifungal/antibacterial
agent which is pharmaceutically acceptable for direct
application to tissue of open and deep wounds and at most
33 1/3 percent by weight ~based on the tota7 weight of the
medi~ine) o~ pharmacologically-acceptable ~physically-
~chemically- and physiologically-~ compatible carrier which
is sufficient (in amount and in physical properties) to
impaxt to ~he admixture a consistency which readily enables
the admixture to be spread on and to adhere to a sponge or
gau2e dressing material and to remain in place when applied
directly to tissue of an open wound or of a burn~ is easily
applied. ~ter a wound is cleaned with water or hydrogen
peroxide, the medicine is ~ormally applied to a 4 x 4 (inch~
sponge with a tongue blade or knife, and the sponge is
then applied to the wound, med~cine-side dow~ (directly on
the tissue~. Alternatively, the medicine is applied
directly on the wouna and is then co~ered wi~h a gau~e
sponge.
The admixture of 20 parts by weight of granulated
sugar ~ S parts by weight of Betadine~ ointment and 2 parts
by weight of Betadine~ solution (Sugardyne~M3
is easily stored. It does not appear to separate over a
period of time whether storage is at normal room temperature,
in a warm room, or in the refrigerator. Sa~ples have been
-2~-
maintained undex each of ~hese conditions for o~er six
months with no separation and no contamination occurring~
There has been no breakdown or reduction in efficacy
despite preparation and storage under non-sterile circum-
stances. Cultures have consistently been negative.
SugardyneT~ has been applied to most wo~lds in an
unsterile fashion with no deletexious outcome. Each of its
ingredients and the ~inal admixture are water soluble and
stain neither skin nor clothing permanently~ If discolora-
tion ~oes occur, it is easily removed with water and a mild
~etergent:~
Sugardyne is not painful when applied. Most
pa~ients have experienced rather rapid relie~ of pain af~er
its application and, when it is applied to a burn wound,
there is al~ost an anesth~tic eeling immediately upon appli~
cation. A few patients have clescribed a slight sensa~îon
o~ heat a~ter application of ';ugardyneTM; rarely do they
describe a sensation of pain. ~he described heat sensation
.
i~ short-lived, and no patient has reported discomort to
an extent that the use of Susardyne M was d~scontinue~.
Sugardyne~M tends to prevent the growth of new
tissue into the dressing material while allowing ull
exuberant granulation tissue to grow. This allows dressing
changPs to be made easily without di~turbing the healing
wound and without pai~ to the patie~t, If it is absorhed, it
is meta~olized and not excreted. ~o known data suggest any
harm secondary tcj thi5 abso~ption. If sucrose is hydrolized
by tissu~ fluids and bacterial enzymes on a wound surface,
-27-
s~
the absorbed materials would be glucose, fruc~ose and/or
their metabolites. Unlike salt (NaCl) these substances are
metabolized rather than excreted from the human body.
Therefore, in elderly patients with cardiac or renal disease
the absorbad produc~s do not present a potential cardio-
vascular-re~al problem. Further, no evidence suggests tha~
the product is diabetagenic, either in the diabetic or non-
diabetic patient. No deleterivus effects have been observed
following the topical administration of povidone-iodine or
of the admixture (except for the previously-noted precaution
for a bleeding tendency when applied to fresh, bleeding wounds).
Where comparisons have been available on the same
patient, a medicine of this invention has out-performed all
other medications commonly used for treating similar wounds.
These medications include Silvadene, Iodoform gauze, Zeroform
gauze, P-I (povidone-iodine) ointment and P-I solution when
used alone.
By comparison, in most burn wounds and wounds where
eschar (scab) formation is common, most other products allow
the ~ormation of eschar while subject medicines do not. As
`~ a result, a very cl~an, rapidly-granulating wound is achieved
: `
within a brief period, usually from one to three days.
Although the use o~ a subject medicine usually reduces any
; need for grafting, wounds requiring such treatment are poten-
tially able to be grafted sooner. Additionallyl most other ?
products require the concomitant use of antibiotics; they
have generally not been necessary when using a subject
medicine, e.g. SugardyneTM.
Total hospital time in the Rurn Unit is greatly
reduced by the use of a subject medicine, since burn wounds
are rapidly converted to clean, healing, non-contaminated
;' .
- 28 -
:~
`s~
wounds. Since further contamination has not been a problem,
the burn patient can be treated with whirlpool and with
multiple dressing changes on the ward rather than in the
Burn Unit. Patients are not only released from the Burn Unit
soonex; th~y, like non-burn patients, are released from the
hospital more quicklyu
SugardyneTM has been especially helpful in treat-
ment of diabetics for whom amputations would be the normal
course of events after the development of a diabetic ulcera-
tion of the foo~. The medicine, even in the face of
rather large contaminated ulcerative area, including osteo-
myelitic bone beneath the ulcer, has resulted in rather
rapid healing of the diabetic ulceration. There has also
been rather rapid healing of the underlying osteomyelitis,
despite the fact that, in many cases, systemic antibiotics
were not used or were minimally effective according to
laboratory testing.
: To date there has been a reduction in the total
number Q amputations performed on diabetics because the
early diabetic ulcer, even with underlying osteomyelitis,
usually responds ~uickly to treatment with, e.gO, SugardyneTMO
Further, wounds to extremities ~especially fingers and toes)
in non-diabetics, normally reguiring amputation, have been
more likely to be ~iable and salvageable. Skin grafts have
; ~ee~ reduced in number since the medicine rapidly tends to
fill the defect created hy ~he wound. It lea~es clean
granulation tissue which subsequently levels off at ~he
level of the normal surrounding soft tissue. It epithe-
lializes with ~ormal, sensitiYe skin and normal skin color.
-2~-
s~
Scars are minimal, defects are minimal, and the patients are
quite happy with the results. ~lost p~tients are able to use
the product at home without significant difficulty and with
a reduced number of follow-up visits, either in the hospital,
in physical therapy or in the physician's of Iice.
Most of the wounds treated with a subject compo-
sitîon are wounds which would be expected to heal more
slowly, since they heal by secondary intention. Actual
results suggest that these wounds heal much more rapidly
; than similar wounds not so treatea; significantly, many
heal as rapidly as wounds treated by primary intention.
Wounds heal in a brief period o~ time with minimal
scarring; healed tissue is free of hypertrophic scarring.
~o date there have been no keloids~ Both laymen and physi-
cians agree that the wounds are healed "without scar."
Color and sensation are generally restored to
normal. Damaged neural elements are encouraged to grow
in such a way as to re-lnnervate the injured area and to
replicate normal se~sation~
Wounds in which ~one was exposed and infected have
responded dramatically to treatment with a subject medicine.
~; Exposed, infected, uncovered and unprotected bone is gener-
.~ .
ally Pxpected to die. Most physicians agr~e ~hat every pos-
sible attempt should be made to cover such exposed bone,
even in the face of its in~ection. Numerou~ operations have
' '
.
-30-
been de~ised to carry out this objective. These operations
include skin grafting, ad~ancing flaps, relief incisions
with advancement of tissue over exposed areas, muscle
releases and muscle transfers, including the use of abdominal,
cross-arm and cross-leg flaps. None of these techniques has
had to be employed when exposed bone was present in a wound
to which a subject medicine was applied. The medicine has
cleaned the wound and the bone, allowing granulation tissue
to cover the wounded area and the bone, with eventual com-
plete filling of the defect and complete co~erage by skin.
No patient treated with this medicine, with or wïthout the
use of systemic antibiotics, has de~eloped osteomyelitis.
These data should be contrasted with the prevalence of
osteomyelitis following open ~ractures competently treated
by standaxd techniques and appropriate antibiotic coverage;
a three to six percent ra~e of osteomyelitis is commonO
Limited experience has shown that a subject
:~ O medicine, applied to fresh first:- and second-aegree burns,
provid~ immediate relie of pain and rapid healing of the
injured area. Where bliste~s are present, they either
rapidly resolve or are protected to allow normal healing
to progress beneat~ them at a more rapid Pace. Therefore~
: in conditions where blisters and potential infection are
otherwise problems (su~h as fracture blisters or cxush
injuries)l a subject medicine has been effecti~ely used to
i~duce rapid heali~g. In patients having third degree (full
thickness) burns and treated wi~h the suhject medicine,
~ ' ' .
-3~- .
rapid conversion of damaged tissue to clean, graftable
granulation ti~sue usually occurs in from three to four days.
one patient (not an adolescent) had acne on his
back, and this condition rapidly healed in response to
treatment with SugardyneT~. This pxoduct has produced
dramatic results in those patients where stitch abscesses
(very similar ~o acne) have been treated following surgery.
They are usually healed completely in one to two days, and
there is gsod reason to b~ieve that a similar response
would be :Eound in ad,o,lescents with acnP. .. ..
In the face of ever-escalating costs for medical
treatment and hospital care, the s~bject compositions
represent medicines which not only produce results in healing
never ~e~ore demonstrated, but which are safely used on a
wide variety of wounds by the patient at home with minimal
direct supervision by a physic.ian. Their components are
readily available and inexpensive. The restrictions on
~heir use are minimal and the advantages found in their use
far outweigh the ~ew aisadvantages.
32-
:
,~
~ ~2565~ `
Case ~istories
In the following cases SugardyneTM is employed as
the medication in the absence of a specific statement to the
contrary.
The typical dressing technique with this medica~
tion invol~es removing any prior dressing, cleansins the
wound with ~oap and water and then wi~h hydrogen peroxide,
applying SugardyneT~ directly to the wound with a tongue
blade, completely covering or filling the wound. Alterna-
tively, the SugardyneTM.is applied to a 4-in~h x 4-inch
sponge and the thus-obtained dressing is applied, face down,
to the wound. Dressings are changed two or three times
daily, adjusting the frequenc~ of dressing changes and
SugardyneTM application to the type and sevexity of the
wound. Moxe serious wounds are changed more frequently,
:~ based on clinical judgment and experience. These techniques
are employed in the following oase histories unless other-
: wise indicated.
:: I. AW is a 22-year old black male whv was
treated for a neuroma involving the left great toe, with
; subse~uent remo~al of the great toenail to excise ~he
neuromar The nai} ~ed was initially treated with Iodoorm.
This was followed by treatment with the medication
~SugardyneT~I) without any use of antibiotics, to effec~
. a rlean-healing nail bed. SugardyneTM dressings were
thereafter changed twice a aay for three days~ ~W was
able to use the medication without pain and was able to
:;
: .
-33-
,
5~
return to work three days following the surgical procedure.
Commentary: This case demonstrates the ease of
application of the medication and the lack of pain while
using the medication on an out-patient basis. It also shows
the capacity of the patient ~o xeturn to work quickly and
during the healing process.
II~ A 70-year-old white female (~A) was treated
for infection secondary to a previous operation for an
ankle fracture. The patient had a draining wound on the
medial aspect of her leg in the area of the previous
surgery. She had been on antibiotics for a considerable
period of time i~ view of an open fracture. She was placed
on daily SugardyneTM dressings, with dressing changes
~after cleaning the wound with hydrogen peroxide) twice
daily, and Keflex ~500 mg) every six hours. The ~7ound
was nearly completely healed (with no signs of in~ection)
within seven days ~ollowing initial treatment. ~er course
was painless.
Comment: ~ith the use of SugardyneTM, the course
.~ . .
of treatment was painless, the resultant healing was rapid
and ~he application was easy.
III. A 12-year-old white female ~BB) was treated
with SugardyneTM for tape burns following a hip operation.
- Pa~nless dressing changes were effected twice a day for
th ee d~ys, after which time the in~ured skin was healed
`~ without a~tibiotics and without lea~ing a scar.
.
-34-
5~3 ,
IV~ A 90-year~old white male (JDj was treated for
multiple fractures of the left foot. He was treated with
a clos~d reduction, and some three weeks later he appeared
to be doing well. When his cast was removed, he had a
mild leg and foot edema. Xe subsequently developed tremen-
dous edema secondary to disuse and his age, and three days
after cast removal he was noted to have erythema and a
weeping infected area involving much of his foot, ankle
and leg secondary to self-induced scratching. The subject
tissue was cleansed with Betadine solution and was there-
after treated with SugardyneT~i over the wounds. Prior to
dressing with SugardyneTM (two times each day), the
involved tissue was washed with hydrogen peroxide. Although
he was directed to take Keflex (500 mg) every six hours,
he subsequently stated that he did not take this anti-
biotic~ One day after his initial treatment with the
medication much o~ the erythema and superficial infection
had cleared. Three days later his in~ection was subs~an-___ _
tially healed, and by six days he had nearly complete.
healing. He went on to complete ~ealing without s~ars.
.~ ~ Comment: This case demonstrates the effective-
-ness of the m~dication in an elderly patient with edema
and erysipelas, without concommitant use of antibiotics~
V. A 23-year-old white male tNE~ sustained a
massive gun-shot (0.35? caliber Magnum) wound to the let
hand on 5eptembPr 26th, 1978, with loss of bone and soft
tissue surrounding and distal to the distal half of the
-35-
third metacarpal and the proximal half of the proximal
phalanx of the long finger, including the MP joint. He
was initially treated with Iodoform packing to the open
wound and was subsequently treated with whirlpool,
hydrogen peroxide and dressing changes wi~h SugardyneTM.
Thereafter, he underwent revision of t~e wound of the
hand and amputation of the long finger. He was discharged
eight days after the original injury~ The wound~ on the
palmar and dorsal surface of the hands were nearly completely
closed two and a half weeks after injury, with no sign of
infection. At four and a half weeks after injury he had
full functional use of the remaining fingers of the hand
and was able to make a good stron~ fist.
Commentary: This case demonstrates the effective
use of the medication in a massi~e gunshot wound involving
the hand with subsequent minimal scarring and rapid
healing, with rapid return to work and ~ull ~unc~ion~
VI. A 6-year-old black male (HF) had apparently
fallen from his bicycle and injured his left Xnee three
. days priox to being seen in the emergency room. Xe was
running a temperature in excess of 102 and had been given
penicillin, but, when first examined, an infected a~rasion
with erythema was noted in and around the surface o the
left knee. The patient was treated in the emergency room
.using Sugardyne ~ and continued on penicillin. One day
later he had clean-healing wounds with marked reduction
: in the siza o the wou~d. The wounds ha~nearly completely
~ -36-
t;~
. .
healed (with no signs of infection and minimal scarring)
within six days thereafter.
Co~runentary: This patient demonstrates rapid
healing of a serious wound, continuing the use of an
antibiotic which had previously been ineffective. He was
treated without pain and with no scarring; he was able to
be treated without hospitalization.
VII. A 28-year-old black fPmale ~BM~) was treated
for an infected burn on the back of har hand with SugardyneTM.
The dressing was changed twice a day. Healing was effec~ed
without~a scar in-less' than one~week.
; VIII. A 36-year-old black male ~DC) sustained a
deep laceration of his right index finger when an engine
block ell on his hand. Initial treatment included sutusing
... . . ... .. _ ..
of the wound~ This was followed by daily dressing changes
with SugardyneTM. Substantial healing was e~fected in nine
days with such treatment. A full range of motion was
obtained in sixteen days, with no scarring.
;; IX. A 49-year-old white female (IN) was involved
in a motox vehicle accident in which she sustained a large
hematoma ~blood collection) on her left calf. This was
drai~ed in the Emergency Room and packed with Iodofoxm.
Subsequently, daily dressi~g changes with Sugardyne
- produced a non-scarred, healed wound in two weeks.
X. A 34-year-ola white male (LP) had been treated
Xor an ulceration and multiple small abscesses involving
nearly the entire distal end o~ a left, below-knee,
-37-
' ., ~ 5
~565i~ ~
amputation stump with a num~er of medications, including
topical creams, ointments, poultices, antibio~ics and
steroids or approximately a year, all to no avail. On
examination, the patient exhibited a very large ulcer with
small abscesses involving the entire 3-inch x 3-inch dia-
meter below-knee amputation ~t~mp on the weight~bearing
surface. The patient appeared ts have both fungal and
bacterial contaminants. He was f1rst treated with
SugardyneTM without concomitant use of antibiotics on
October 31st, 1978~ and two weeks later he had approximately
3J4 closure of the distal-stump wound with minimal amounts
of drainage. The SugardyneTM dressing was changed three
times each day after cleansing the wound (each time) with
. soap, water and hydrogen peroxide. The wound had nearly
completely healed within one month, despite the fact that
the patient continued to work during the entire cour~e
of treatment.
Comment: This massively-ulcerated wound,
unresponsive to a number of other acceptable treatments,
responded rapidly and without hospitalizatio~ to SugardyneTM
without interruption of a work schedule. The patient had
no complaints of pain during the use of this medication;
he found it easy to use and ea~y to apply.
XI~ A 5-year-old white male (RC~ was injur~d
when his right foot was caught in a log splitter. He
;~ sustained necrosis to ~he skin on the lateral aspect of
his foot and a mas~ive crush injury to the entire foot,
.
-38-
25~
.
resulting in tremendous s~elling and loss of normal blood
supply distally. He subsequently underwent a fasciotomy
to the foot and was treated with whirlpool and SugardyneTM
to his wounds a~ter pac~ing with Iodoform for two days.
Wh~n the Iodoform packing was removed, the wound was free
from blood. The patient made excellent progress, and the
wound had nearly completely healed by the end of three weeks.
By 27 days the patient had complete healing with minimal
scarring both medially and laterally. He had complete
filling in of the medial defect and complete restoration
of the lateral`area which-had prèviousIy ~eén nëcrotic.
There was ~ormal sensation, normal color, minimal scarring
and full range of motion and function.
Comment: Expected healing time was markedly
reduced without any necessity for a sXin graft. The
patient had no complaints of pain during application of
the SugardyneT~i.
XII. A 16-year-old white male (TS) sustained
: ..
a ~inger-tip amputation on December ~5th, 1978. Initial
. ~aC~; r ~n
treatment was with an-~hr~xnr dresslng. On the second
day following the amputation the Iodoform dressing was
removed and the wound was aresse~ with SugardyneTM.
Dressing changes were mada three times each day. By ~he
fourth day the patient had a clean-healing wound with
good granulation tissue in the wound. On the eight day
the patient had excellent pxogression of healing with a
small indentation in the center of the ~ound; he was
-39-
, . .
continued on SugardyneTM dressing changes three times a day
with intermittent cleansing with hydrogen peroxide. The
wound was nearly completely healed six days later and, by
January 11th, 1979, the wound was comple~ely healed. ~he
patien~ had normal sensation and normal color wi~h a very
slight defect in the fingertip in terms of to*al length.
Commentary: Treatment using SugardyneTM resulted
in restoration of finger length, alleviated need for a
skin graft, avoided antibiotics and resulted in a rapidly-
healing wound. Moreover, the total expense of treatment
was markedly less than would be expected with o~her medic-
aments.
XIII. A 7-year-old white male ~DP) was treated
- following a crushing injury tto the tip of his right index
finger) sustained in a motorcycle accident. He had been
treated for from 10 to 12 days prior to this time and was
noted to have a massive infection in~volving the entire
end of his finger, from the last joint to the tip. He was
~` treated with SugardyneTM, using three to four dressing
ch~nges per day (cleansing the wound each time with hydrogen
peroxide). Nearly complete healing was effected within one
week; complete healing was accomplished in 13 days without
any scarring.
XIV. A 61-year-old black male ~GK) was treated
for injuries to his left hand. He had sustained crush injuries
and deep lacerations (including tendons) of the index, long
and ring fingers. He was initially treated with Iodoform;
this was followed by whirlpool and application of SugardyneTM.
.
.
- 40 -
~`'1 `.
~s~
Dressing changes were effected twice a day with hydrogen
peroxide. Nearly complete healing ensued with minimal
scarring. A full passive range of motion was r~stored
within four weeks. Complete healing of the long- and ring-
finger injuries was accomplished in less than two weeks.
XV. A S-year-old white male (~H) apparently
fell and suffered multiple abrasions of the right hand,
the right side of his face and forehead. He was seen one
aay later, having an elevated temperature, and his wounds
ware covered with pus. After cleansing, his wounds were
dressed with SugardyneTM. His mother c~anged hls dressings
twice a day, and the patient was placed on erythromycin
(250 mg) every six hours. Two days later the patient's
wounds were without signs of infection and were nearly
completely healed. There were DO signs of scars.
Comment: The healing was rapid. The patient did
not complain of any pain during the course of dressing
changes.
.. . ... . .
XVI. A 41-year-old ~hite male SRK~ sustained
a deep abrasion to the right shin at its midpoint, down to
the bone. This wound was infected with Mississipi River mud
and water. Within two days it wa~ highly contaminated and
infected. Treatment was initiated on the second day with
5ugardyneTM dressings, changed twice daily a~ter cleansing
(each time) with hydrogen peroxide. Tha wound proceeded
to heal rapidly without further in~ection and was covered
with skin with a slight brownish discoloration, but which
41
25~
had full sensation and full hair covering.
Commentary: This case demonstrates the effective~
ness of SugardyneTM on wounds with open exposed infected
bone and sot tissues and without concomitant use o~ anti-
biotics, resulting in rapid and painless healing.
X~II. A 41-year-old white male surgeon ~RK),
who sustained first and second degree burns to his left hand
after a match book exploded in his hand, resulting in burns
on the ~olar and ~orsal aspects involving the base of the
thumb, ~he palm,~ of the hand and all four fingers.
Immediat'e treatment consisted of'applica'tion-,'of Suga~rdyneTM,
and a dry dressing. The patient was subsequently able to
remove the dressing in four hours with complete resolution
of th~ first and second degree burns, including all but
two small blisters. Pai-n relie was immediate, and the
patient was able to return to a full schedule of duties,
including full use of the hand, in four hours. Ee was
able to operate the next morning with no evidence of
burns'and no pain. ~
.
Comment: This case demonstrates the effective-
ness both in terms of rapid healing and in terms of pain
relief in the b~rned patient. It demonstrates the capacity
of SugardyneTM to allow a patient to r~turn to full working
capacity quickly and without pain.
XVIIIo A 63-year-old white male (A~) sustained
a gunshot wound in 1965 to his right ankle, with subsequent
fusion o~ the ankle. The patient has intermittently had
purulent drainage Erom the ankle and such drainage has
-
-4~-
~5~
generally cultured StaphyZococcus aureus. He has generally
had to be on antibi9tics because of the drainage, which
ordinarily healed after a pexiod of swelling and drainage.
The patient has been treated with SugardyneT~ since June
1978, and has had a r~duction in the nu~ber of flare-ups.
~e has also had rapid healing with using Sugardyn~TM when
a flare-up occurred. He generally begins SugardyneT~l
txeatment as soon as he sees any erythematous area; healing
usually follows within one or two days~
Commentary: This patient demonstrates the
effectiYeness o SugardyneT~5 i~ chronic osteo~yeliti`s`-~nd ~-
also shows the effectiveness of this medicament when
compared with this patient's usual response to antibiotics
alone.
XVIX. A 22-year-old white femal2 ~E~j was
treated in the Emergency Room after an automobile accident
on August 5th, 1978, in which she sustained multiple
abrasions and lacerations and a deep laceration to the
medial aspect of her left knee~ A~ter cleansing, the
deep lacerations of the knee were closed over a drain,
~nd the patient was dressed with SugardyneT~l. Two days
thereafter her wo~md was heating well wi$hout signs of
infection. By the sixth day her wounds wexe nearly
completely healed. Her wounds subsequently healed with
minimal signs of scaxring in all abrasion and laceration
sites, an~ she had no keloid formation~ Dressings were
changed twice a day during treatment.
~'s~
Commentary This patiPnt was able to be treated
without antibiotics and made an uneventful, unscarred,
comfortable recovery using SugardyneT~.
XX. A 13-year-old white male (JW) suffered a
laceration and ~racture to his left elbow one week prior
to treatment in the Emergency Room. He had an er ~ emJatous
area on the lateral aspect of the elbow and was ~ril~.
~e appeared to have an early infected laceration of the
left el~ow. Treatment includea cleansing with Betadine~
7 scrub and dressing with SugardyneTM. The pàtient was
4 placed on Keflexi(25 ~g~ every six ~ours.-:On the ~llowing
day the patient's symptomatology had diminished considerably,
and much of the erythema was gone. Within two days there-
after th~ early infection had completely healed.
; Comment: T~is case dëmonstrates rapid healing
of an infected laceration and open ~racture by use of
SugardyneTM used concomitantly with antibiotics.
XYI. A 35-year-old black male (cW) was admitted
~~~ ~ ~~ to the hospital after haviny been stabbe~ through and
~ ~ .
through the mid portion of the left arm at the leve~ of
the bone. The patient's initial treatment consisted of
intravenous antibiotics and open packing of the wound
~o prevent infectionO ~e was ~ubsequently ~reated with
SugardyneTM in the hospital and on an out-patient basis
until the wound was clean enou~h to be closed with sutures.
This was done three weeks later, and he went on to an
uneventful recovery without further infection.
-~4-
Comment: The potential for infection in this
serious wound was alleviated by the use of SugardyneTM and
antibiotics. The patient healed with minimal scarring and
no infection. Much of his treatment was accomplished on
an out-patient basis.
XXIIo A 54-year-old white female (~) was
trea~e~ for a massive infection of her left leg. The
înfection ~ubsequently resulted in a massive abscess,
re~uiring an open amputation on June 5th, 1978. Because
o~ the slow resolution of her infection, s~.e was tr ated
with S~gardyneTM as well as antibiotics,and this resulted
in complete cleaning and granulation of the distal stump.
Subsequently she underwe~t a re~ision of this amputation
and was able to be discharged ~Erom the hospital six days
later. By the end of three weeks the stump W2S completely
healed, with no signs o~ even a linear scar. She was
subse~uently fitted with a below-knee pros~hesis and has
had minimal problems sinoe that time. The SugardyneT~
treatmen~ involved dressing changes thrPe times each day.
Antihiotics were adminis~ered every six hours during
~reatment.
Commentary: A difficult problem in a middle
aged diabetic was handled successfully using Sugardyne
with rapid healing, so that a second procedure ~Oula be
done to enable the patient to be discharged Irom the
hospital sooner. Her course was markedly improved using
this medicament, and the potential for death following an
infectio~ o~ this type was avoided with the concomitant use
of SugardyneT~I and antibiotics. No progress was made ~rior
. -45-
~S~i5~
to treatment with`SugardyneTM.
XXIII A 54-year-old white female (MW~ developed -
stich abscesses following surgery on her wrist. She was
treated with SugardyneTM and with Keflex (250 mg) every
six hours. She subsequently proceeded to heal well with
no sign of a scar.
Comment: This case demonstrates the us~ of
SugardyneTM for a commonly-encountered problem following
surgery.
XXIV. A 35-year-old black male (JK) was injured
on May 28th, 1978, while riding his motorcycle. He suffered
multiple abrasions of both upper extremities, including the
shoulders, outer surfaces of the arms and forearms, includ-
ing.the hand and knuckles (especially on the rlght side).
The wounds were init:ially treated in the Emergency
Room. A~ter one day they were covered with large amounts
of pus and appeared to be near~y burned. The wounds were
clea~sed with Betadine solution and were redres~ed with
SugardyneTM. Within two days the wounds wexe clean; ther
.~ was ~resh granulation tissue and no sign of infection. The
wounds were nearly completely filled wi~hin one week, and
st were completely skinned over with normal negroid skin.
Three days later his wounds were nearly ~ully healed, and
he had brown skin covering all previously-injured tissue.
The tissue was normal in sen~ation.
Commentary: The patient was able to treat his
wounds at home wikhout infection and ~ith a good end result
in what could ~ery well ha~e become a serious burn-like
,~ I P s L~skltn I c TM
~1~7 ~ in~ectio~. ~is wounds healed with Sugardyne
: -46-
~ c3~ ,
with no scarring and no depigmentatio~. His treatment ~Jas
without pain.
XX~. A 26-year old white ~ale (Jl~C~ had sustainec
a dirty laceration of the mid portion of the volar aspect
of his right forearm, wnich subsequently became infectPd
(despite antibiotics) some five days following initial
treatment~ The initial treatment included removal of a few
sutures and packing of the wound with Iodof~rm. Two days
thereafter the woundr which was pu~ulent, but had no
~leeding, was treated with Su~ardyneT~. It subsequently
healed without further infection and with minimal scarring
in approximately 7 days. The patient dressed his wounds
on a daily basis, using hydrogen peroxide to wash the woun~,
SugardyneT~ and a dry dressinq.
Commentary: The pat:ient was able to continue
work despite thîs infected wolmd and was able to heal
rapidly without pain secondary to his injury.
.; . ~ .
XXVI. A 58-year-old white male l~G3 had under-
gona a partial amputation of his right foot secondary to
diabetic gangrene approximately 1~ years prior to being
seen. He had had ulcerations o the foot, requiring
multiple hospitali~ations on ~early a monthiy basis for
approximately two or three yeaxs. During that period o~
~ime lthe patient had become addic~ed ~o medica~ions fox
pai~. EIe had been treated with a large ~rariety of the
usual medications, both systemic and oral antibiotics~
as well as wound dressing materials, to treat his ulcer.
-47-
~56~ '
As a general rule, when his ulcer became ba~ly infected,
his diabetes went out of control, and the patient was
forced to be hospitalized. During the course o:E almost a
year the patient has been using SugardyneTM for daily
dressing changes, washing his wOuna with soap and water
and hydrogen peroxide prior to each such change. During
this period he has not required hospitalization, nor has
he required contlnuous antibiotics as he had in the past.
~is diabetes has been stable, and he has been free of any
pain, thereby freeing him of his need for nar~otics.
. Commentary: Although this patient's diabetes
and chronic ulcerations of the foot have not healed, he
has bee~ stabilized to the pOillt where repeated hospitali-
zations have not been necessary, and his diabetes has been
well controlled ~ith the use oi SugardyneT~ for basic
~h~onic wound care. He is now cured of his p~e~ious
narcotio addiction.
XXVII. A 29-year-old white male (C~) was
injured thre~ or four days prior to being seen. A large
plank fell across his ankle, in1icting soft-tissue injury
as well as.a significant sprain. The patient subs2qu~ntly
developed an abscess which was drain~d and treated with
SugardyneT~I. The initial treatment included pac~ing with
Iodoform dressin~, which was removed after one and a half
days, at which time there was some purulencer but no
bleeding. Within four days after the initial treatment
, -~8-
~s~so
the wound was nearly completely healed.
Comment: The patient was able to be treated on
an out~patient basis ~or a rather significant in~ury to
his ankle, the injury did not require use of concomitant
antibiotics. The patient was able to use SugardyneT~ with
ease and without pain.
XX~III. A 10-year-old black male ~PD) sustained
a deep laceration and contusion to the distal portion of
the right index finger, including a fracture of the tuft,
when a bri~k fell on it. The patient's initial treatment
was with SugardyneTM. The patient underwent one Emergency-
Room dressing change and wound check. Within four days
the wound was completely healecl with no signs of s~arring.
Commentary: This case demonstrates rapid unevent-
ul healing with minimal hospil:ali~ation time,no antibio-
tics, ease of application and minimal pain for the patient.
XXIX. A 30-yeax-old white female (SH) was treated
in the Emergency Room after having suffered an axe injury
with an open fracture of the middle phalanx of the left
long finger. She was treated primarily with open reduction,
internal fixation and suturing o~ the lacerated extensor
tendon, placed on antibiotics and SugardyneT~ dressing
changes after suturing of the skin wound. She healed
rapidly without infection. She subsequently had minimal
visible s5ar of the finger wi~h no Xeloid formation. Three
months ater injury the fracture was completely healed.
:
.
~49-
Commentary: A seriously-injured, nearly amputated
finger was c~pable of treatment without hospitalization of
the patient; it healed with SugardyneTM treatment without
scarring. The patient was able to treat herself at ho~e
with minimal discomfort.
XXX. A 7-year-old white male (JL) suffered near
amputations ~by an axe) of his index and long fingers of
his left hand. The patient underwent initial cleansing and
stabilization of fingers with K-wires. He had repair of
extensor tendons and clos~re of skin, dressing wounds with
SugardyneTM. The patient made an uneventful recovery, with
nearly complete healing of wounds within one week. There
was no infection. Subsequently, open fractures healed with-
out incident. The patient had no visible scars.
Comment: Case illustrates rapid healing of
contaminated injured tissue, including bone, without
infection with SugardyneTM as the primary wound dressing
agent.
XXXI. A 59-year-old meat cutter ~HB) who
amputated the distal one-third of his right long finger
(distai phalanx) while working as a butcher, received
initial treatment in the Emergency Room. This treatment
involved stopping the bleeding from the soft tissue and
bone in the end of the amputated tiy. Treatment was with
Iodoform gauze, followed in one day with Sugardyne M.
Subsequent dressing changes were twice daily, with hydrogen
peroxide cleansing preceding each. The patient proceeded
to complete healing in four weeks, with regeneration of
- 50 -
'
.
'~ ' . ' ~ ..
~ ~2~tj~
approximately three-fourths Qf the lost tissue, with no
skin graft. He had good feelin~ and excellent pulp over-
lying the fingertip.
Comment: This case illustrated regeneration of
tissue following fingertip amputation, utilizing Sugardyne
foridaily dressing changes. No antibiotics were used
despite open exposed bone. The ~reatment was substantially
painless.
XXXII. A 10-year-old white male (JW~ was treated
~or a two-inch sliver embedded in the sole of his right
foot~ After cleansing the foot, the sliver was xemoved
under local anesthesia. SugardyneTM was used to dress the
wound, and the patient was placed on antibiotics by mouth~
The oot healed completely in two days without infection.
and wi~h dressing changes twic:e a day.
~ omment: This case demonstrates the efect of
SugardyneT~ on contaminated tissue, both in t~rms o~
pre~enting infection and o~ rapid healing~ The oral anti-
biotic was Keflex, which was administered every six hours
during treatmen~.
XXXIII. A 16-year-old white male (WM) had been
injured 1~ days prior to being seen; the fourth and fiffh fingers
o his left hand had been sprayed with li~uid propane,
resulting in a frostbite injury ~full thickness - third
degree)/ especially to the mid-dorsal portion of his
fifth finger~ Bo~h fingers were initially badly blistered
and, despite treatment elsewhere wi~h Betadine~ (P-I) solution,
. -51-
. ' . . .
~25~C~
~oth fingers had become infected. Nearly two-thirds of
the dorsum of the fifth finger was infectea over both the
PIP and DIP joints. On January 4th, 1979, nineteen days
after injury, the patient was started on SugardyneTM
dressings two to three times each day. Within four days
~hereafter the wound was clean, with no signs of inectionO
On the fourth day a 1/8-inch border of skin had appeared
at the wound edges; 11 days later the wound was more than
50 percent covered with skin. Two weeXs later the wound
was completely healed, with no evidence of scar. The
patient had obtained a full range of motion of all finger
joints.
Comment: This case demonstrates the effecti~eness
of SugardyneTM on a difficult burn type wound, overlying
~oint creases. Rapid healingl, despite previous ~reatment
with P-I solution alone, which had been ineffective fox
three weeks.
XXX}~. A 15-year-old white male (XB~ suf~ered
an open fracture of his right tibia, wi~h bone protruding
through the skin, while riding ~ motorcycle on July 24th,
19 7~ . Irrigation and debriaement was carried out in
an operating room; stabilization was obtai~ed wi~h X-wires
and a ca t. The wound was approximated~over a drain and
was subsequently treated with SugardyneTM three times a
ph~s~ ~e~l
day, withA~Es~c1 twice daily. Within 16 days the wound
had complete~y healed with no infection. The patient had
been on antibiotics, i.~. and orally,for seven days. The
.~
-52-
~Z5i~5~ '
recovery was uneventful with no osteomyelitis.
Comment: This case illustrates an open fracture
which was successfully treated with Sugardyne~, with no
wo~nd or bone infection and no tissue scarring.
XXXV. A 15-year-old white male (T~ suffered
open contaminated fracture of his right tibia. He was
treated in an operating room with irrigation and debrideme~t
of the open wound~ with closure loosely over a drain. The
fracture was stabilized using K-wires and a cas~. Further
treatment included removal of the drain and i.v, antibiotics.
SugardyneTM was started on the third day,`with~resu-ltant
healing without infeotion. The bonP healed in usual fashion
without infection.
Comment: This case demonstrates effectiveness
of SugardyneT~l in open fractures. There was normal ra~id
healing of the wound and fracture without infection, and
there was no scar.
XXXVI. A 13-year-old black male ~VW) was treated
for a large abscess of his le t knee. He had sustained an
injury to the knee some three weeks earlier in a fall. The
injuxed area developed a hematoma which de~eloped a 3-inch x
4-inch abscess. The abscess was drained undex local anes-
thesia on February 27, 7 9790 Large amounts of pus were
drained from ~he abscess, which was packed with Iodofor~,
and dressed with Sugardy~eTM~ The patient was seen for
repacking in the Emergency ~oom each day over the weekend,
and ne~rly complete resolution of ~he abscess was effected
53-
in :Eour days. Nearly complete healing had occurr~d in six
days. The patient made complete recovery with no xecurrence
of the abscess.
Comment: This case illus~rates usefulness or
SugardyneT~ to help draw pus from a wound or abscess. It
also shows the use of this medicament in the complete rapid
healing of a wound.
The invention and its advantages are readily
understood from the precPding description,. Various changes
may be made in the process and in the compositions without
departing from~the spirit or scope of the invention or
sacrificing its material advantages. The process and
compositions hereinbPfore descr:ibed are merely illustrative
of.preferred embodiments of the invention.
:
.
:
o54--
