Clinical safety and efficacy of a novel thermoreversible polyhexanide-preserved wound covering gel.

ABSTRACT

BACKGROUND: An ideal topical formulation for wound therapy does not exist. The aim of this study was to develop a novel improved therapeutic option for the treatment of acute and chronic wounds. METHODS: A transparent wound gel which is in a liquid state below and in a gel state at or above room temperature was developed. Forty-four patients were included in this open randomized controlled single-center study. Flammazine served as control in the treatment of skin graft donor sites. Wounds were assessed for time of dressing change and overall satisfaction of patients and health care providers. The data were analyzed using the nonparametric Mann-Whitney test. RESULTS: The wound gel proved to be superior in comparison with Flammazine with respect to wound assessment (p = 0.002), staining (p = 0.007), leaking (p = 0.032) and smell (p = 0.034). Flammazine showed favorable results regarding the parameters dehydration of the dressings (p = 0.012) and wound adherence (p = 0.005). The evaluation of the overall dressing change process showed no significant differences. CONCLUSION: The thermoreversible wound gel containing polyhexanide allows for good handling and wound assessment. This study demonstrated a high satisfaction level of patient and health care providers, and the wound gel proved an effective alternative to commonly used treatments.