Evaluating the Efficacy of a Tocotrienols-Loaded Dressing in Wound Care for Pressure Ulcers
A Prospective, Double-Blinded, Randomized Controlled Trial to Evaluate the Efficacy of a Formulated Dressing Containing Tocotrienols in Wound Care for Pressure Ulcers
Monash University Malaysia
114 participants
Jan 21, 2026
INTERVENTIONAL
Conditions
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.
Eligibility
Plain Language Summary
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Interventions
Tocotrienol-loaded formulated dressing is designed as all-in-one easy to use dressing. This is the first dressing formulated to contain tocotrienols. The dressing is expected to speed up the healing process compared to control.
The standard care serves as a control, using a conventional hydrocolloid dressing. This control group allows for a comparison with the intervention to assess differences in outcomes at the end of the study.
Locations(1)
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NCT07694583