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| Name | Class |
|---|---|
| Malaysia Palm Oil Board | OTHER_GOV |
| University Malaysia Medical Centre | UNKNOWN |
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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:
Researchers will compare Tocotrienols-loaded formulated dressing to conventional dressing (standard of care as control) in pressure ulcers.
Participants will:
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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tocotrienol dressing | Experimental | Participants in this experimental arm will receive a Tocotrienol-loaded dressing. The dressing will be applied topically to the affected area, and the treatment will continue for a duration of 6 weeks. |
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| Conventional dressing | Placebo Comparator | Participants in this experimental arm will receive a conventional dressing as standard care (control). The dressing will be applied topically to the affected area, and the treatment will continue for a duration of 6 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tocotrienol-loaded formulated dressing | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Reduction 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). | Day 0, Day 1, Day 3, Day 5, Day 7, Day 15, Day 22, Day 29, Day 35, Day 43 |
| Measure | Description | Time Frame |
|---|---|---|
| Reduction in wound area | This secondary outcome measure was chosen because a greater reduction in wound area would indicate faster healing. | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Lay Hong Dr. Chuah, PHD, MPharm, R.Ph | Contact | +6017-3592799 | alice.chuah@monash.edu |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Malaya Medical Centre | Recruiting | Kuala Lumpur | Selangor | 59100 | Malaysia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33241700 | Background | 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. | |
| 32028609 |
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| ID | Term |
|---|---|
| D003668 | Pressure Ulcer |
| ID | Term |
|---|---|
| D012883 | Skin Ulcer |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| Conventional dressing | Device | 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. |
|
|
This secondary outcome measure provides an indication of the wound healing rate throughout the study. |
| Day 0, Day 1, Day 3, Day 5, Day 7, Day 15, Day 22, Day 29, Day 35, Day 43 |
| 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. |
| 30395878 | Background | 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. |
| 28061321 | Background | 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. |
| 23097676 | Background | 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. |