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.

Evaluation of angiogenesis, epithelialisation and microcirculation after application of polyhexanide, chitosan and sodium chloride in rodents

“…These growth factors are known to be the key factors for stimulating angiogenesis . Our findings confirm the low toxicity and excellent tissue tolerance of polyhexanide . The advantage over the control group is possibly also caused by an improvement in the tissue perfusion and therefore increased metabolism .…”

“…Its transparency allows a direct assessment of the wound. Our previous studies as well as the data obtained from other groups showed excellent results concerning toxicity and wound healing in experimental and clinical setups .…”

“…Chitosan is a polysaccharide of randomly distributed β‐ ‐linked d ‐glucosamine. It is a natural material obtained from crustacean shells.…”

Intravital Pathophysiologic Comparison of Frostbite and Burn Injury in a Murine Model

“…The treatment of burns includes cooling, antiphlogistics, and painkillers, local disinfection, and moist dressings [13][14][15].…”

Biopolymers as Wound Healing Materials: Challenges and New Strategies

“…The open randomized controlled single-center study was carried out on 44 patients in 2 parallel groups (Traumasept®wound covering gel vs. Flammazine®). The transparency of the thermosensitive gel formulation and absence of staining allowed for good wound assessment, without the need for painful cleaning, and the change from the fluid to the gel state enabled easy handling and filling the wound cavities (Goertz et al, 2010). One of the most important parameters of the injured tissue pathology is to stop the bleeding and to protect the area with a protective support material in the first step.…”