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

Peter M Vogt, Joerg Hauser, Stefan Mueller, Bjoern Bosse, Michael Hopp, Peter M Vogt, Joerg Hauser, Stefan Mueller, Bjoern Bosse, Michael Hopp

Abstract

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 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.

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.

Keywords: Liposomal povidone–iodine hydrogel; Mesh skin grafts; Microbial colonization; Povidone–iodine ointment; Pseudomonas aeruginosa; Staphylococcus aureus; Topical antisepsis; Wound healing; Wound infection.

Figures

Fig. 1
Fig. 1
Mean re-epithelialized area (%) during the study (with exploratory p values). Number of patients was 10 for PVP–I ointment (n = 8 for study Day 12) and 4 for PVP–ILH

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