PALUMBO F.P., SERANTONI S., ABBRITTI F.

1. USE$OF$A$NEW$SURFACTANT$GEL$WITH$SILVER$
SULPHADIAZINE$IN$THE$TREATMENT$OF$CHRONIC$
LEG$ULCERS$AND$DIABETIC$FOOT$
ITALIAN$MULTICENTRIC$EXPERIENCE$
$
PALUMBO$F.P.1$–$SERANTONI$S.2$–$ABBRITTI$F.3$
1$–$LABORATORIO$DI$$VULNOLOGIA$–$PALERMO$
2$–$CASA$DI$CURA$“VILLA$FIORITA”$–$PRATO$$
3$–$U.O.$CHIRURGIA$VASCOLARE$–$A.O.$G.$SALVINI,$GARBAGNATE$MILANESE$

2. USE$OF$A$NEW$SURFACTANT$GEL$WITH$SILVER$SULPHADIAZINE$IN$THE$TREATMENT$OF$
CHRONIC$LEG$ULCERS$AND$DIABETIC$FOOT:$ITALIAN$MULTICENTRIC$EXPERIENCE$
18,5$
19$
19,5$
20$
20,5$
21$
21,5$
22$
22,5$
23$
$$
males$20$
females$23$
Age: 26-91 years Average age 70.9 yy
AETIOLOGY
Venous 19
Arterial 10
Hypertensive 3
Mixed 5
Post-traumatic 5
Unknown 1
Vasculitis 3
Diabetic 9
Infection 1
Pressure 2
A$new$technological$advanced$device$(Silver$Sulphadiazine$Gel)$was$tested$on$58$
lesions$selected$in$43$paents$in$a$mulcentric$observaonal$study.$
180$days$follow_up$results$are$reported$and$discussed.$$
$
PALUMBO F.P. – SERANTONI S. – ABBRITTI F.

3. METHODS(
USE$OF$A$NEW$SURFACTANT$GEL$WITH$SILVER$SULPHADIAZINE$IN$THE$TREATMENT$OF$
CHRONIC$LEG$ULCERS$AND$DIABETIC$FOOT:$ITALIAN$MULTICENTRIC$EXPERIENCE$
PALUMBO F.P. – SERANTONI S. – ABBRITTI F.
All$ paents$ underwent$ to$ an$ anamnesc$ and$ clinical$ $ and$ instrumental$ evaluaon$ (when$
required).$
Data$ were$ collected$ using$ a$ schedule$ $ to$ detect$ wound$ characteriscs.$ QL$ index$ was$
administred$to$all$paents.$
Dressing$ changes$ were$ performed$ from$ one$ to$ three$ mes$ a$ week,$ depending$ on$ the$
characteriscs$of$the$lesions.$
In$selected$paents,$a$mullayer,$mulcomponent,$inelasc$bandage$was$applied.$$
The$study$was$completed$in$30$days.$Our$preliminary$report$was$presented$at$EWMA$2012.$$
Paents$were$selected$according$to$condions$of$the$injury$at$me$T0,$regardless$of$me$of$
onset$and$treatment$prior$to$enrollment$date.$$
GROUP$A$ 0_10$cm2$ 30$
GROUP$B$ 11_20$cm2$ 10$
GROUP$C$ 21_100$cm2$ 16$
GROUP$D$ >100$cm2$ 2$
According$to$wound$areas$paents$were$enrolled$in$$
4$groups.$

4. PALUMBO F.P. – SERANTONI S. – ABBRITTI F.
USE$OF$A$NEW$SURFACTANT$GEL$WITH$SILVER$SULPHADIAZINE$IN$THE$TREATMENT$OF$
CHRONIC$LEG$ULCERS$AND$DIABETIC$FOOT:$ITALIAN$MULTICENTRIC$EXPERIENCE$
ULCERS$AREA$ PLANIMETRIC$METHOD$
PAIN$ VISUAL$SCALE$
EXUDATE$ N.$DRESSING$CHANGE/WEEK$
QUALITY$OF$LIFE$
INDEX$(QL)$
ACTIVITY,$DAILY$LIVING,$HEALTH,$SUPPORT,$
OUTLOOK$
The$coordinators$of$the$study$all$received$the$same$training$in$vulnology$and$are$all$
vascular$surgeons.$
$
RESULTS$
$
In$all$almost$paents$an$improvement$of$obiecve$data$was$observed.$Reducon$of$
exudaon$and$of$inflamaon$in$the$skin$around$the$ulcers$were$observed$since$the$
first$ week$ of$ gel$ applicaon.$ These$ were$ accompanished$ by$ reducon$ of$ average$
wound$areas$and$of$pain.$
Aler$60$days$rates$reducon$of$area$were$respecvely$of$78,1%$in$Group$A,$of$75,89%$
in$Group$B$and$of$66,63%$in$Group$D.$In$Group$C$was$observed$a$decreasing$rate$of$
67,7%$aler$180$days.$
$
$
$

5. USE$OF$A$NEW$SURFACTANT$GEL$WITH$SILVER$SULPHADIAZINE$IN$THE$TREATMENT$OF$
CHRONIC$LEG$ULCERS$AND$DIABETIC$FOOT:$ITALIAN$MULTICENTRIC$EXPERIENCE$
PALUMBO F.P. – SERANTONI S. – ABBRITTI F.
Follow_up$at$180$days$
$
All$lesions$<$20$cm2$$(30)$healed$in$about$60_75$days.$Two$lesions$>$100$cm2$$(Group$D)$underwent$
to$surgical$implant$of$homologous$skin$gral.$3$paents$were$treated$successfully$for$5$weeks$with$
autologous$platelet$gel$(5$lesions).$
The$others$lesions$(16)$were$treated$with$gel$applicaon$once$a$week$to$complete$healing.$At$180$$
days$only$4$lesions$were$not$healed.$
Drop$out$2$paents$(1$hearth$failure,1$stroke).$
$
Pain$percentages$decreased$respecvely$of$50%$in$Group$A,$76,8%$in$Group$B$and$of$87,7%$in$Group$
D$aler$60$days.$We$observed$a$decrease$of$82,8%$in$Group$C$paents$aler$180$days.$
pain$data$were$correlated$to$exudaon$rate$that$decreased$respecvely$of$57,1%$in$Group$A,$71,4%$
In$Group$B$and$0f$66,6%$in$Group$D$aler$60$days.$In$Group$C$we$observed$a$reducon$rate$of$60,8%$
aler$180$days.$
A$very$important$data$was$collected$by$QL_Index$administraon.$Increase$of$QL_Index$was$respecvely$
of$35,2%$in$Group$A,$of$44,9%$in$Group$B$and$of$20,9%$in$Group$D$aler$60$days.$An$increase$of$20,9%$
Was$reported$in$Group$C$aler$180$days.$

6. $
$
PALUMBO F.P. – SERANTONI S. – ABBRITTI F.
USE$OF$A$NEW$SURFACTANT$GEL$WITH$SILVER$SULPHADIAZINE$IN$THE$TREATMENT$OF$
CHRONIC$LEG$ULCERS$AND$DIABETIC$FOOT:$ITALIAN$MULTICENTRIC$EXPERIENCE$
0$
1$
2$
3$
4$
5$
6$
7$
8$
9$
T$0$ T$30$ T60$ T90$ T180$
GROUP$A$
GROUP$B$
GROUP$C$
GROUP$D$
PAIN$
0$
50$
100$
150$
200$
250$
T0$ T30$ T60$ T180$
A$
B$
C$
D$
WOUND$AREAS$
_80$
_75$
_70$
_65$
_60$
A$
B$
C$
D$
_100$
_80$
_60$
_40$
_20$
0$

7. PALUMBO F.P. – SERANTONI S. – ABBRITTI F.
USE$OF$A$NEW$SURFACTANT$GEL$WITH$SILVER$SULPHADIAZINE$IN$THE$TREATMENT$OF$
CHRONIC$LEG$ULCERS$AND$DIABETIC$FOOT:$ITALIAN$MULTICENTRIC$EXPERIENCE$
QL_INDEX$
0$
1$
2$
3$
4$
5$
6$
7$
8$
9$
T0$ T30$ T60$ T90$ T180$
A$
B$
C$
D$
0$
10$
20$
30$
40$
50$
1$ 2$ 3$ 4$
0$
0,5$
1$
1,5$
2$
2,5$
3$
3,5$
T$0$ T$30$ T60$ T90$ T180$
GROUP$A$
GROUP$B$
GROUP$C$
GROUP$D$
EXUDATE$
_50$
_40$
_30$
_20$
_10$
0$

8. PALUMBO F.P. – SERANTONI S. – ABBRITTI F.
USE$OF$A$NEW$SURFACTANT$GEL$WITH$SILVER$SULPHADIAZINE$IN$THE$TREATMENT$OF$
CHRONIC$LEG$ULCERS$AND$DIABETIC$FOOT:$ITALIAN$MULTICENTRIC$EXPERIENCE$
Use$of$SSD)GEL$in$a$mixed$leg$ulcer$(before$and$a:er$2$weeks$of$treatment)$
Use$of$SSD)GEL$in$a$post$operaAve$dehiscence$$(before$and$a:er$60$days)$$

9. PALUMBO F.P. – SERANTONI S. – ABBRITTI F.
USE$OF$A$NEW$SURFACTANT$GEL$WITH$SILVER$SULPHADIAZINE$IN$THE$TREATMENT$OF$
CHRONIC$LEG$ULCERS$AND$DIABETIC$FOOT:$ITALIAN$MULTICENTRIC$EXPERIENCE$
DISCUSSION$
$
Aim$of$this$study$was$to$test$the$effecveness$of$SSD_Gel$in$all$types$of$leg$ulcers.$Thanks$to$its$
properes$(it$can$solidify$at$body$temperature)$this$device$may$conform$to$the$boqom$of$the$ulcer$
and$exert$its$anbacterial$acvity$taking$advantages$of$its$features$on$the$surface$tension$(acon$on$
biofilm).$In$this$way$it$is$possible$to$explain$its$an_inflammatory$acvity$due$to$the$anbacterial$and$
the$sense$of$freshness$that$every$paent$has$reported$from$the$first$applicaon.$
The$ follow_up$ to$ 180$ allowed$ to$ observe$ in$ the$ lesion$ resistant$ $ to$ therapy$ a$ progressive$
improvement$in$symptoms$and$an$increase$ $of$the$scores$of$the$QL_index$reducing$the$discomfort$
associated$with$excessive$exudaon$and$malodour$and$thus$allowing$the$recovery$of$the$social$life,$$
which$is$especially$important$in$the$elderly.$
The$SSD_Gel$interacts$with$the$surface$of$“non$healing”$ulcers$probably$through$a$mechanism$of$
reducing$ the$ surface$ tension$ of$ the$ biofilm$ and$ thus$ allowing$ the$ exposure$ to$ the$ acon$ of$ the$
bacterial$wall$to$silver$Sulphadiazine$linked$to$it.$
In$our$experience$the$disappearance$of$the$sign$of$infecon$and$growth$of$ssue$proliferaon$was$
observed$with$greater$frequency$in$small$lesions.$Many$of$the$injures$that$are$larger$than$20$cm2$
were$treated$by$skin$grals.$Their$engralment$in$all$cases$showed$indirectly$the$anbacterial$efficacy$
of$the$product.$

10. PALUMBO F.P. – SERANTONI S. – ABBRITTI F.
USE$OF$A$NEW$SURFACTANT$GEL$WITH$SILVER$SULPHADIAZINE$IN$THE$TREATMENT$OF$
CHRONIC$LEG$ULCERS$AND$DIABETIC$FOOT:$ITALIAN$MULTICENTRIC$EXPERIENCE$
AKNOWLEDGEMENTS$
$
A$SPECIAL$THANKS$TO$DR.$ELSA$LO$IACONO$AND$DR.$ELENA$PATORNO$FOR$THE$PREPARATION$OF$DATA$ON$
PATIENTS.$
$
$
$
REFERENCES$
$$
Ahamed$M.,$Alshali$M.,$Siddiqui$Mk$
SILVER$NANOPARTICLES$AND$HUMAN$HEALTH$
Clin$Chim$Acta$2012$Dec$14;411(23_24):1841_8$
$
Benziane$H.,$Karfo$R.,$Siah$S.,$Taoufik$J$
ANALYSE$PHARMACEUTIQUE$DE$LA$PRESCRIPTION$DES$ANTIBIOQUES$AU$SERVICE$DES$BRULES$ET$CHIRURGIE$PLASTIQUE$DE$L’HOPITAL$MILITAIRE$D’INSTRUCTION$MOHAMMED$V,$MAROC$
Ann$of$Burn$and$Fire$Disaster$–$vol.$XXIV,$n.3$–$September$2011$
$$$
Gear$A.J.,$Hellewell$TB,$Mazzarese$P.M.,$Arnold$P.B.,$Rodeheaver$G.T.,$Edlich$R.F.$
A$NEW$SILVER$SULPHADIAZINE$WATER$SOLUBLE$GEL$
Burns$1997$Aug;23(5):387_91$
$$
Bocchiov$G.,$Robov$E.$
THE$USE$OF$A$TOPICAL$ANTIBACTERIAL$AGENT$(SILVER$SULPHADIAZINE)$ON$SOFT_TISSUE$WOUNDS$
Minerva$Chir.$$1990$May$15;45(9):677_681$
$$
$
Palumbo$F.P.,$Serantoni$S.,$Abbriv$F.$
Use$of$a$new$surfactant$gel$with$Silver$Sulphadiazine$in$the$treatment$of$chronic$leg$ulcers$and$diabec$foot:$preliminary$results.$
EWMA$2012,$Wien$
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