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

The purpose of this study is to investigate the effects of the dressing containingTocotrienols on patients with pressure ulcers. This research is necessary becausepressure ulcers is common in patient with critical illness and bedbound. Therefore,proper wound care management is crucial. Tocotrienols has been proven to have numeroushealth benefits, and in this study, its use will be investigated for pressure ulcers inhuman subjects. A total of 114 participants from patients admitted to UMMC (UniversityMalaya Medical Centre) will be participating in this study. The whole study will lastabout 3 years and each participant will last about 43 days or 6 weeks.This study is important because it is hypothesised that the Tocotrienols‐loaded wounddressing will be able to reduce wound complications on application through itsanti‐inflammatory, anti‐oxidant and wound healing effects, and provide better wound careoutcome. This study also provides fundamental groundwork to expand the use ofTocotrienols in surgical and non‐surgical wound management, as well as scar reduction inaesthetic and cosmetic applications.The participants that are invited to participate in the research study because they havepressure ulcers that requires Tocotrienols‐loaded formulated dressing. Participantsshould not take part in this study if they have multiple known allergies to various typesof dressings, if their wound is determined to be infected, or if there are of skinnecrosis requires special dressing and topical antibiotic treatment. Additionally,individuals with any medical conditions that, in the investigator's opinion, couldpotentially compromise their safety, adherence, or ability to successfully complete theclinical trial will also be excluded from participation.This is a double‐blinded randomized controlled trial. The procedure that is being testedis a Tocotrienols‐loaded formulated dressing on Stage 1 and Stage 2 pressure ulcers. Theparticipants will be randomly assigned to one of the treatment groups below:Group 1: Tocotrienols‐loaded formulated dressing Group 2: Conventional hydrocolloiddressing (standard of care as control) Neither the participants nor the doctor will knowwhich group the participants are assigned to but in the case of emergencies, thisinformation will be available to the doctor.During the length of the study, the participants involvement will include: ‐ Being screened by the study doctor, who will examine their pressure ulcers andrecruit them if they are eligible. ‐ If eligible, they will be randomly assigned to either the control or treatmentgroup. ‐ Undergo 24‐hour allergy testing with patch of Tocotrienol‐loaded dressing andstandard hydrocolloid dressing ‐ Assess skin sensitivity testing the next day, and if qualify, will be started onfirst dosing. ‐ Attend follow‐up visits on days 3, 5, 7, 15, 22, 29, 35 and 43, where additionalquestions and assessments will be completed.This study is sponsored by the Malaysian Palm Oil Board (MPOB) who will pay for all studyproducts and procedures. All the information obtained in this study will be kept andhandled in a confidential manner, in accordance with applicable laws and/or regulations.Data from the study may be archived for the purpose of analysis, but the participants'identity will not be revealed at any time.