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

Introduction: Infection 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.

Methods: An 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 cm, 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.

Results: The 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.

Conclusion: Our 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 Registration: The trial was conducted prior to mandatory registration of drug products, PVP-ILH represents a medicated device in the EU and many other countries.

Funding: Mundipharma Research GmbH & Co. KG.