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

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

Overview

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.

Detailed description

The purpose of this study is to investigate the effects of the dressing containing Tocotrienols on patients with pressure ulcers. This research is necessary because pressure ulcers is common in patient with critical illness and bedbound. Therefore, proper wound care management is crucial. Tocotrienols has been proven to have numerous health benefits, and in this study, its use will be investigated for pressure ulcers in human subjects. A total of 114 participants from patients admitted to UMMC (University Malaya Medical Centre) will be participating in this study. The whole study will last about 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 wound dressing will be able to reduce wound complications on application through its anti-inflammatory, anti-oxidant and wound healing effects, and provide better wound care outcome. This study also provides fundamental groundwork to expand the use of Tocotrienols in surgical and non-surgical wound management, as well as scar reduction in aesthetic and cosmetic applications.

The participants that are invited to participate in the research study because they have pressure ulcers that requires Tocotrienols-loaded formulated dressing. Participants should not take part in this study if they have multiple known allergies to various types of dressings, if their wound is determined to be infected, or if there are of skin necrosis requires special dressing and topical antibiotic treatment. Additionally, individuals with any medical conditions that, in the investigator's opinion, could potentially compromise their safety, adherence, or ability to successfully complete the clinical trial will also be excluded from participation.

This is a double-blinded randomized controlled trial. The procedure that is being tested is a Tocotrienols-loaded formulated dressing on Stage 1 and Stage 2 pressure ulcers. The participants will be randomly assigned to one of the treatment groups below:

Group 1: Tocotrienols-loaded formulated dressing Group 2: Conventional hydrocolloid dressing (standard of care as control) Neither the participants nor the doctor will know which group the participants are assigned to but in the case of emergencies, this information 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 and recruit them if they are eligible. * If eligible, they will be randomly assigned to either the control or treatment group. * Undergo 24-hour allergy testing with patch of Tocotrienol-loaded dressing and standard hydrocolloid dressing * Assess skin sensitivity testing the next day, and if qualify, will be started on first dosing. * Attend follow-up visits on days 3, 5, 7, 15, 22, 29, 35 and 43, where additional questions and assessments will be completed.

This study is sponsored by the Malaysian Palm Oil Board (MPOB) who will pay for all study products and procedures. All the information obtained in this study will be kept and handled 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.

Interventions

• Device Tocotrienol-loaded formulated dressing
  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.
• Device Conventional dressing
  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.

Primary outcome measures

• Change in Pressure Ulcer Scale for Healing (PUSH) score [Time frame: Day 0, Day 1, Day 3, Day 5, Day 7, Day 15, Day 22, Day 29, Day 35, Day 43]

Secondary outcome measures (2)

• Change in total wound surface area [Time frame: Day 0, Day 1, Day 3, Day 5, Day 7, Day 15, Day 22, Day 29, Day 35, Day 43]
• Percentage of patients with completely healed wound [Time frame: Day 0, Day 1, Day 3, Day 5, Day 7, Day 15, Day 22, Day 29, Day 35, Day 43]

Eligibility criteria

Inclusion criteria

• 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
• Stated willingness to comply with all study procedures and availability for the duration of the study

Exclusion criteria

• 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
• Any (medical) conditions that would, in the opinion of the investigator, potentially compromise the safety or compliance of the subject or may preclude the subjects' successful completion of the clinical trial
• Allergic to dressings during 24-hour pre-study allergy test

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Quadruple blind

Primary purpose

Treatment

Study locations

Malaysia · 1 center

• University Malaya Medical Centre — Kuala Lumpur

Publications

• Guo HF, Mohd Ali R, Abd Hamid R, Chang SK, Rahman MH, Zainal Z, Khaza'ai H. Epidermal Growth Factor and Tocotrienol-Rich Fraction Cream Formulation Accelerates Burn Healing Process Based on Its Gene Expression Pattern in Deep Partial-Thickness Burn Wound Model. Int J Low Extrem Wounds. 2022 Dec;21(4):544-554. doi: 10.1177/1534734620971066. Epub 2020 Nov 26. PMID 33241700
• Guo HF, Abd Hamid R, Mohd Ali R, Chang SK, Rahman MH, Zainal Z, Khaza'ai H. Healing Properties of Epidermal Growth Factor and Tocotrienol-Rich Fraction in Deep Partial-Thickness Experimental Burn Wounds. Antioxidants (Basel). 2020 Feb 3;9(2):130. doi: 10.3390/antiox9020130. PMID 32028609
• Ruiz-Tovar J, Llavero C, Perez-Lopez M, Garcia-Marin A. Effects of the application of vitamin E and silicone dressings vs conventional dressings on incisional surgical site infection in elective laparoscopic colorectal surgery: a prospective randomized clinical trial. J Hosp Infect. 2019 Jul;102(3):262-266. doi: 10.1016/j.jhin.2018.10.021. Epub 2018 Nov 3. PMID 30395878
• Alias D, Ruiz-Tovar J, Moreno A, Manso B, Diaz G, Duran M, Garcia-Olmo D. Effect of Subcutaneous Sterile Vitamin E Ointment on Incisional Surgical Site Infection after Elective Laparoscopic Colorectal Cancer Surgery. Surg Infect (Larchmt). 2017 Apr;18(3):287-292. doi: 10.1089/sur.2016.199. Epub 2017 Jan 6. PMID 28061321
• Lin TS, Abd Latiff A, Abd Hamid NA, Wan Ngah WZ, Mazlan M. Evaluation of topical tocopherol cream on cutaneous wound healing in streptozotocin-induced diabetic rats. Evid Based Complement Alternat Med. 2012;2012:491027. doi: 10.1155/2012/491027. Epub 2012 Oct 14. PMID 23097676

Identifiers

NCT: NCT07694583 · RSCH ID-24-01422-IRV

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗