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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorMonash University Malaysia

About this trial

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 criteria

Qualifiers

The included participants or caretakers are older than 18 years with at least one pressure ulcer that was stage I-II as classified by the National Pressure Ulcer Advisory Panel and the European Pressure Ulcer Advisory Panel (NPUAP/EPUAP)

Exhibited a pressure ulcer surface area of <80 cm2 (multiplication of the major and minor diameters of the wound surface)

PUSH (version 3.0) score of >5 that was likely to heal during the 6-month study period

Provision of signed and dated informed consent form

Disqualifiers

Stage III & IV pressure ulcers requiring different standard of care

Multiple known allergies to other types of dressings

Wound deemed to have an infection

Area of skin necrosis that requires special dressing and/or topical antibiotic treatment

Trial design

Treatments tested in this trial

  • Tocotrienol-loaded formulated dressing
  • Conventional dressing

Treatment groups

114 Participants
are divided into 2 treatment groups

Locations

1

Map coordinates are unavailable for these locations. Locations are shown below instead.

University Malaya Medical CentreRecruiting59100, Kuala Lumpur, SelangorMalaysiaMalaysia

Sponsors and collaborators

Monash University Malaysia

Lead sponsor

Malaysia Palm Oil Board

Collaborator

University Malaysia Medical Centre

Collaborator