EWMA 2013 - Ep525 - Use of a new active surface surfactant gel with silver sulphadiazine in the treatment of leg skin ulcers and diabetic foot lesions –

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$

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$43$pa\ents$in$a$mul\centric$observa\onal$study.$180$days$follow_up$results$are$reported$and$discussed.$$$

PALUMBO F.P. – SERANTONI S. – ABBRITTI F.

METHODS(



All$ pa\ents$ underwent$ to$ an$ anamnes\c$ and$ clinical$ $ and$ instrumental$ evalua\on$ (when$required).$Data$ were$ collected$ using$ a$ schedule$ $ to$ detect$ wound$ characteris\cs.$ QL$ index$ was$administred$to$all$pa\ents.$Dressing$ changes$ were$ performed$ from$ one$ to$ three$ \mes$ a$ week,$ depending$ on$ the$characteris\cs$of$the$lesions.$In$selected$pa\ents,$a$mul\layer,$mul\component,$inelas\c$bandage$was$applied.$$The$study$was$completed$in$30$days.$Our$preliminary$report$was$presented$at$EWMA$2012.$$

Pa\ents$were$selected$according$to$condi\ons$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$areas$pa\ents$were$enrolled$in$$4$groups.$



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$pa\ents$an$ improvement$of$obiec\ve$data$was$observed.$Reduc\on$of$exuda\on$and$of$ inflama\on$ in$ the$ skin$ around$ the$ulcers$were$observed$ since$ the$first$ week$ of$ gel$ applica\on.$ These$ were$ accompanished$ by$ reduc\on$ of$ average$wound$areas$and$of$pain.$Aler$60$days$rates$reduc\on$of$area$were$respec\vely$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.$$$$$



Follow_up$at$180$days$$All$lesions$<$20$cm2$$(30)$healed$in$about$60_75$days.$Two$lesions$>$100$cm2$$(Group$D)$underwent$to$surgical$implant$of$homologous$skin$gral.$3$pa\ents$were$treated$successfully$for$5$weeks$with$autologous$platelet$gel$(5$lesions).$The$others$lesions$(16)$were$treated$with$gel$applica\on$once$a$week$to$complete$healing.$At$180$$days$only$4$lesions$were$not$healed.$Drop$out$2$pa\ents$(1$hearth$failure,1$stroke).$$

Pain$percentages$decreased$respec\vely$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$pa\ents$aler$180$days.$pain$data$were$correlated$to$exuda\on$rate$that$decreased$respec\vely$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$reduc\on$rate$of$60,8%$aler$180$days.$A$very$important$data$was$collected$by$QL_Index$administra\on.$Increase$of$QL_Index$was$respec\vely$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.$

$$



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$



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$



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$$(before$and$a:er$60$days)$$



DISCUSSION$$Aim$ of$ this$ study$was$ to$ test$ the$ effec\veness$ of$ SSD_Gel$ in$ all$ types$ of$ leg$ ulcers.$ Thanks$ to$ its$proper\es$(it$can$solidify$at$body$temperature)$this$device$may$conform$to$the$boqom$of$the$ulcer$and$exert$its$an\bacterial$ac\vity$taking$advantages$of$its$features$on$the$surface$tension$(ac\on$on$biofilm).$In$this$way$it$is$possible$to$explain$its$an\_inflammatory$ac\vity$due$to$the$an\bacterial$and$the$sense$of$freshness$that$every$pa\ent$has$reported$from$the$first$applica\on.$The$ follow_up$ to$ 180$ allowed$ to$ observe$ in$ the$ lesion$ resistant$ $ to$ therapy$ a$ progressive$improvement$ in$symptoms$and$an$ increase$ $of$the$scores$of$the$QL_index$reducing$the$discomfort$associated$with$excessive$exuda\on$and$malodour$and$thus$allowing$the$recovery$of$the$social$life,$$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$ ac\on$ of$ the$bacterial$wall$to$silver$Sulphadiazine$linked$to$it.$In$our$experience$the$disappearance$of$the$sign$of$ infec\on$and$growth$of$\ssue$prolifera\on$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$the$an\bacterial$efficacy$of$the$product.$



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$15;45(9):677_681$

$$$Palumbo$F.P.,$Serantoni$S.,$Abbriv$F.$Use$of$a$new$surfactant$gel$with$Silver$Sulphadiazine$in$the$treatment$of$chronic$leg$ulcers$and$diabe\c$foot:$preliminary$results.$EWMA$2012,$Wien$$$$$

$$

Health & Medicine

EWMA 2013 - Ep525 - Use of a new active surface surfactant gel with silver sulphadiazine in the treatment of leg skin ulcers and diabetic foot lesions –