Efficacy and Safety of a Carbopol40 Hydrogel Functionalized With Plasma-Activated Water (PAW) in the Treatment of Chronic Wounds: A Randomized Controlled Trial

What this Trial Is About

Researchers are evaluating the effectiveness and safety of a new hydrogel made from Carbopol40 neutralized to pH 5.5 and combined with Plasma-Activated Water (PAW) for treating chronic wounds. These wounds include diabetic foot ulcers, pressure injuries, surgical wound dehiscence, and arterial or venous ulcers that have not healed for more than three months. The study aims to see if the PAW-hydrogel speeds up wound closure, reduces bacteria in the wound, and is safe and well-tolerated compared to standard advanced wound care. Participants will be randomly assigned to one of two groups. The experimental group will receive topical applications of the PAW-hydrogel 2 to 3 times a week after wound cleaning with sterile saline. The hydrogel is applied as a uniform layer covering the entire wound and covered with a sterile dressing. The control group will receive the usual advanced wound care including cleaning, mechanical debridement if needed, and conventional dressings without the PAW-hydrogel. Treatments continue for up to 12 weeks or until the wound fully closes. During the 12-week follow-up, participants will be assessed weekly for wound area reduction and bacterial load at specific intervals. Other evaluations include pain levels recorded at each treatment visit, wound tissue quality assessments, and monitoring for any treatment-related side effects. The number of dressing changes and overall safety will also be tracked. Participants provide informed consent and may leave the study at any time without affecting their medical care.

PAW-Hydrogel for Chronic Wound Healing