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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
Tocotrienol-loaded formulated dressing
DeviceTocotrienol-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.
Conventional dressing
DeviceThe 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.
Treatment groups
114 Participants
are divided into 2 treatment groupsGroup A: Tocotrienol dressingExperimental treatment 1 intervention
Group B: Conventional dressingPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Change in Pressure Ulcer Scale for Healing (PUSH) score
This primary outcome measure was developed by The National Pressure Ulcer Advisory Panel to monitor pressure healing over time. The range of the score is 0-17, that is, from completely healed to the greatest severity. The scale consists of 3 domains: length times width (10-scale), exudate amount (none, light, moderate, and heavy), and tissue type (necrotic tissue, slough, granulation tissue, epithelial tissue and closed wound).
Time frame
Day 0, Day 1, Day 3, Day 5, Day 7, Day 15, Day 22, Day 29, Day 35, Day 43Secondary outcomes
1
Change in total wound surface area
This secondary outcome measure was chosen because a greater reduction in total wound surface area would indicate faster healing. The surface area will be measured using digital wound imaging app.
Time frame
Day 0, Day 1, Day 3, Day 5, Day 7, Day 15, Day 22, Day 29, Day 35, Day 432
Percentage of patients with completely healed wound
This secondary outcome measure provides an indication of the wound healing rate throughout the study.
Time frame
Day 0, Day 1, Day 3, Day 5, Day 7, Day 15, Day 22, Day 29, Day 35, Day 43Locations
1Map coordinates are unavailable for these locations. Locations are shown below instead.
University Malaya Medical CentreRecruiting59100, Kuala Lumpur, Selangor
Malaysia
MalaysiaSponsors and contacts
Click on the lead sponsor to view all of their trials.
Monash University Malaysia
Lead sponsor
Malaysia Palm Oil Board
Collaborator
University Malaysia Medical Centre
Collaborator
Source ClinicalTrials.gov