Polyvinyl pyrrolidone-iodine liposome hydrogel improves epithelialization by combining moisture and antisepsis. A new concept in wound therapy

Moist treatment of wounds has been shown to improve epithelialization. howe ver at an increased risk of bacterial infection. In this monocentric, rando mized, open, phase II pilot study of polyvinyl pyrrolidone-iodine, a well-e stablished topical antiseptic was tested in a new liposomal complexed form in patients receiving meshed skin grafts after burns or reconstructive proc edures. Mesh skin graft sites of 36 patients were dressed either with the n ew polyvinyl-pyrrolidone-iodine liposome hydrogel formulation (Betasom hydr ogel) (n = 21). or chlorhexidine-gauze (n = 15). After the first dressing c hange, wounds were assessed daily and documented every other day until they were healed. Methods of analysis included clinical assessment, photoplanim etry (rate of epithelialization), impedance measurement (moisture of surfac e and wound healing quality), patient's assessment of pain and other sensat ions, and thyroid hormones (T-3, T-4, and TSH). The rate of epithelializati on was improved with Betasom hydrogel compared to chlorhexidine-gauze on da y 11 (96.3% vs. 75.9% p = 0.056) and significantly on day 13 (100% vs. 82.3 % p = 0.005), respectively. Impedance measurements showed an earlier return to normal values (day 9) in Betasom-hydrogel-treated wounds as opposed to chlorhexidine treatment (day 11). Clinical assessment indicated significant ly better antiseptic efficacy (p = 0.002) and wound healing quality (p = 0. 004) of Betasom hydrogel. Graft loss occurred at a significantly lower rate in Betasom treatment (n = 1: 5%), than in chlorhexidine treatment (n = 5: 35.7%) (p = 0.001). No relevant adverse events or clinically relevant chang es of thyroid hormones were observed with Betasom hydrogel. The rationale o f this new polyvinyl pyrrolidone-iodine liposomal formulation was based on the properties of liposomes that provide higher moisture to the wound surfa ce, release PVP-iodine at a low rate, and target the substance more exactly by interaction with the cell surface. These initial clinical results show earlier epithelialization and better healing in wounds treated with polyvin yl pyrrolidone-iodine liposome hydrogel, which combines moisture and antise psis, compared to wounds treated with a conventional antiseptic chlorhexidi ne-gauze.