A comparison of sea-cucumber based gel to conventional hydrogels in wound healing
| ISRCTN | ISRCTN15108764 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN15108764 |
| Secondary identifying numbers | USM/JEPeM/16060218 |
- Submission date
- 11/01/2018
- Registration date
- 16/02/2018
- Last edited
- 15/10/2018
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Other
Plain English summary of protocol
Background and study aims
Gamat (sea cucumber) has been widely used as a traditional medication/supplement for various ailments in South-east Asia, e.g. Malaysia, Indonesia, Thailand, Philippines and China. Gamat extracts contain many nutrients which may play a role in tissue repair, and they have been tested in rats and as a toothpaste in humans. However, to date, there have been no studies on human wounds. The aim of this study is to assess the effectiveness of Gamat gel in comparison with hydrogel in the treatment of skin graft donor sites.
Who can participate?
Patients with partial thickness wounds created as an after effect of skin graft harvesting
What does the study involve?
Both gels are applied to the patient simultaneously on the same wound divided into two areas. The duration of treatment is 10-14 days with follow up at day 21, then at 6 to 9 weeks. The effect is judged as which wound heals more on a specific day. Pain tolerance, itch tolerance, and scar quality are also assessed on both wound surfaces.
What are the possible benefits and risks of participating?
The results could show whether Gamat gel heals human cutaneous wounds faster or better. The risks would be allergic reactions, but these have not been reported so far.
Where is the study run from?
Hospital Universiti Sains Malaysia (Malaysia)
When is the study starting and how long is it expected to run for?
August 2016 to September 2017
Who is funding the study?
Universiti Kebangsaan Malaysia (Malaysia)
Who is the main contact?
Dr Adzim Poh Yuen Wen
Contact information
Public
A-3-3, Laman Baiduri
Jalan SS12/1, Wangsa Baiduri
Subang Jaya
47500
Malaysia
 ORCID ID |
0000-0002-0903-6152 |
|---|
Study information
| Study design | Single-center prospective single-blinded comparative study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Non randomised study |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details to request a patient information sheet |
| Scientific title | A prospective case-control comparative study to evaluate the efficacy of Gamat gel in comparison with hydrogel in treatment of skin graft donor sites |
| Study objectives | Null hypothesis: There is a no significant difference in the rate of epithelialization between Gamat gel dressing and Duoderm® Hydroactive® Gel dressing on skin graft donor sites. |
| Ethics approval(s) | Local ethics board in Hospital Universiti Sains Malaysia (JEPeM), 21/11/2016, ref: USM/JEPeM/16060218 |
| Health condition(s) or problem(s) studied | Skin graft donor site wounds |
| Intervention | This is a prospective, single-blinded, comparative clinical trial involving patients in Hospital Universiti Sains Malaysia with partial thickness wounds which were created as an after effect of skin graft harvesting. Any patient requiring skin grafting and fulfilling the inclusion/exclusion criteria will be approached preoperatively for recruitment. Both gels (sea-cucumber based gel and Duoderm (r) gel) will be applied on the patient simultaneously on the same wound, which is geometrically divided into two areas correspondingly. The effect is judged as which wound epithelializes more on a specific day. Pain tolerance, itch tolerance, and scar quality are also assessed on both wound surfaces. Duration of treatment 10-14 days. Follow up at day 21, then at 6 to 9 weeks. |
| Intervention type | Other |
| Primary outcome measure | Wound epithelialization, assessed by clinical judgment and calculated as percent of surface of wound epithelialized at day 10, 14 and 21 after intervention |
| Secondary outcome measures | 1. Pain and pruritus assessed with visual analogue scale at day 10, 14 and 21 2. Scar quality assessed with modified Vancouver scar scale (MVSS) at follow up (week 6 to 9) |
| Overall study start date | 01/08/2016 |
| Completion date | 04/09/2017 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Mixed |
| Sex | Both |
| Target number of participants | 25 |
| Key inclusion criteria | 1. All patients with partial thickness wounds after split-skin graft harvesting 2. This thickness is at 0.2 mm (0.008 inch); harvested with a specified dermatome 3. Skin-graft donors > 25cm2 wide 4. Consented patients 5. Patients compliant to the treatment protocol |
| Key exclusion criteria | 1. Accidental full thickness harvesting 2. Non-compliant patient, causing dressing to dislodge 3. Patients with history of allergy to seafood/ sea cucumber 4. Patients with uncontrolled diabetes mellitus, on steroid medications or who are immunocompromised 5. Pregnancy 6. Patient with skin pathology (eczema etc) |
| Date of first enrolment | 29/12/2016 |
| Date of final enrolment | 03/07/2017 |
Locations
Countries of recruitment
- Malaysia
Study participating centre
Kubang Kerian, Kelantan
16150
Malaysia
Sponsor information
Hospital/treatment centre
Department of Reconstruction Sciences
Universiti Sains Malaysia, Kubang Kerian
Kelantan
Kota Bharu
16150
Malaysia
"ROR" |
https://ror.org/0090j2029 |
|---|
Funders
Funder type
University/education
Government organisation / Local government
- Alternative name(s)
- Universiti Kebangsaan Malaysia (UKM), Universiti Kebangsaan Malaysia (UKM), Malaysia, ukminsta, Universiti Kebangsaan Malaysia - UKM, Universiti Kebangsaan Malaysia (Malaysia), University Kebangsaan (Malaysia), UKM
- Location
- Malaysia
Results and Publications
| Intention to publish date | 18/03/2018 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | To submit to BioMed Central Complementary and Alternative Medicine Journal. |
| IPD sharing plan | The datasets generated during and/or analysed during the current study are/will be available upon request from Dr Adzim Poh Yuen Wen. A copy of the raw data has been submitted to the Medical Sciences Studies Centre (or Pusat Pengajian Sains Perubatan [PPSP]) of Hospital Universiti Sains Malaysia. All patients were assigned a coded number to protect anonymity. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/12/2018 | Yes | No |
Editorial Notes
15/10/2018: Publication reference added.
