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Published on: March 25, 2020
Efficacy of Conventional and Liposomal Povidone-Iodine in Infected Mesh Skin Grafts: An Exploratory Study
Peter M Vogt1, Joerg Hauser2, Stefan Mueller3
1Hannover Medical School, Hannover, Germany.
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.
Insights
Povidone-iodine ointment effectively cleared infections and promoted healing in meshed skin grafts. Liposomal povidone-iodine hydrogel also aided healing but showed some graft loss, suggesting ointment is better for severe infections.
Area of Science:
- Wound healing and regenerative medicine
- Dermatology and skin grafting
- Infectious disease management
Background:
- Topical antisepsis is crucial for preventing infection and graft loss in meshed skin grafts (MSGs).
- Infection significantly threatens wound healing outcomes and graft survival.
Purpose of the Study:
- To investigate the efficacy of 3% liposomal povidone-iodine hydrogel (PVP-ILH) versus povidone-iodine ointment in infected MSGs.
- To compare antibacterial and wound healing properties of PVP-ILH and povidone-iodine ointment.
Main Methods:
- A pilot Phase II study enrolled 14 patients with infected MSGs in an exploratory satellite group.
- Patients received either PVP-ILH or 10% povidone-iodine ointment, applied daily.
- Wound evaluation included photoplanimetry, microbiology, and subjective patient/physician assessments.
Main Results:
- Povidone-iodine ointment demonstrated rapid re-epithelialization (90% by Day 6) and complete bacterial clearance by Day 10.
- PVP-ILH showed rapid re-epithelialization (72% by Day 6) with improved subjective healing quality markers.
- Four patients (40%) treated with PVP-ILH experienced partial graft loss; none in the povidone-iodine ointment group did.
Conclusions:
- Povidone-iodine ointment is effective for managing infected wounds, particularly when high-concentration povidone-iodine is needed.
- PVP-ILH showed comparable benefits in healing quality markers for larger infected wounds, but with a risk of graft loss.
