Efficacy of Conventional and Liposomal Povidone-Iodine in Infected Mesh Skin Grafts: An Exploratory Study.

Abstract

IntroductionInfection is a major threat to wound healing and a leading cause of graft loss in patients undergoing meshed skin grafts (MSGs). Therefore, topical antisepsis is important in the overall treatment scheme.MethodsAn exploratory satellite group of 14 patients with infected MSGs were enrolled as part of a prospective, randomized, controlled, parallel-group, open-label, pilot Phase II study that investigated the efficacy and tolerability of 3% liposomal povidone–iodine hydrogel (PVP–ILH, Repithel®; RepiGel®) versus chlorhexidine gauze in non-infected MSGs. The satellite group included both patients with infected wound beds prior to grafting and patients with infection of a previously placed graft, with MSG sizes ranging from 50 to 1000 cm2, who were randomized to treatment with (PVP–ILH) or 10% povidone–iodine ointment (Betaisodona®; BETADINE®). Medication was applied in a 2-mm layer and dressing changes with identical application of study medication took place daily. Wounds were evaluated by photoplanimetry, microbiologically and subjectively by patients and physicians.ResultsThe results for the main study group have been reported previously. In the satellite group, both PVP–ILH and povidone–iodine ointment performed remarkably well with respect to lowering the bacterial count and restoring wound healing, with different emphasis. Povidone–iodine ointment showed excellent antibacterial efficacy with no detectable microorganisms by Day 10, and rapid re-epithelialization (mean 90% by Day 6). PVP–ILH also demonstrated rapid re-epithelialization (mean 72% by Day 6) with a trend towards improved subjective measures of wound healing quality. Four patients (40%) receiving PVP–ILH experienced partial graft loss (10–15% of total MSG area); no patients in the povidone–iodine ointment group experienced graft loss.ConclusionOur results suggest that povidone–iodine ointment has a strong role in managing infected wounds, especially when a high concentration of povidone–iodine may be warranted, while PVP–ILH indicated similar beneficial results on markers of wound healing quality in larger infected wounds.Trial RegistrationThe trial was conducted prior to mandatory registration of drug products, PVP–ILH represents a medicated device in the EU and many other countries.FundingMundipharma Research GmbH & Co. KG.