Clinical Research Directory

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

Sponsor: Monash University Malaysia

Summary

The goal of this clinical trial is to investigate the effects of the dressing containing Tocotrienols on patients with stage 1 and stage 2 pressure ulcers. The main questions it aims to answer are: * Will the dressing containing Tocotrienols lead to a reduction in the Pressure Ulcer Scale for Healing (PUSH) Score? * Will the dressing containing Tocotrienols help heal the participants' pressure ulcer wounds? * Will the dressing containing Tocotrienols lead to reduction in wound surface area? * What is the percentage of patients with completely healed wounds by the end of the study? Researchers will compare Tocotrienols-loaded formulated dressing to conventional dressing (standard of care as control) in pressure ulcers. Participants will: * Have their pressure ulcers checked by a study doctor to ensure they are infection-free and suitable ulcer fitting the inclusion criteria * Undergo 24-hour allergy testing with patch of Tocotrienol-loaded dressing and standard hydrocolloid dressing * Be randomly assigned to one of three groups if they qualify: control, vehicle-control, or treatment group * Assess skin sensitivity testing the next day, and if qualify, will be started on first dosing. * Attend follow-up visits on days 1, 3, 5, 7, 15, 22, 29, 35 and 43, where additional questions and assessments will be completed.

Official title: A Prospective, Double-Blinded, Randomized Controlled Trial to Evaluate the Efficacy of a Formulated Dressing Containing Tocotrienols in Wound Care for Pressure Ulcers

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