Evaluating Tocotrienol-Infused Dressings Versus Standard Hydrocolloid Dressings for Treating Stage 1 and 2 Pressure Ulcers in Adults A Double-Blind Randomized Controlled Trial

What this Trial Is About

Researchers are investigating the effects of a new wound dressing containing Tocotrienols on patients with stage 1 and stage 2 pressure ulcers. This study aims to determine if this dressing can reduce the Pressure Ulcer Scale for Healing PUSH score, help heal wounds, decrease wound surface area, and increase the percentage of patients with fully healed wounds. The trial compares the Tocotrienols-loaded dressing to a conventional hydrocolloid dressing as standard care. It is a double-blinded randomized controlled study involving 114 participants and sponsored by Monash University Malaysia and the Malaysian Palm Oil Board. Participants will be randomly assigned to one of two groups one receiving the Tocotrienols-loaded dressing and the other receiving a conventional dressing. Both dressings will be applied topically to the affected area for about six weeks. Before treatment, participants will undergo 24-hour allergy testing with both dressings to ensure safety. Follow-up visits are scheduled on days 1, 3, 5, 7, 15, 22, 29, 35, and 43 to monitor progress and collect data. During the study, participants will be assessed regularly by study doctors who will examine their pressure ulcers and conduct skin sensitivity tests. Measurements including the PUSH score and wound surface area will be recorded at multiple time points to evaluate healing. The study will also track the percentage of patients with completely healed wounds. All study products and procedures are provided at no cost, and personal information is kept confidential. The total participation time for each individual is about six weeks.

Evaluating the Efficacy of a Tocotrienols-Loaded Dressing in Wound Care for Pressure Ulcers