Condition category
Not Applicable
Date applied
Date assigned
Last edited
Retrospectively registered
Overall trial status
Recruitment status
No longer recruiting
Publication status

Plain English Summary

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

Trial website

Contact information



Primary contact

Dr Adzim Poh Yuen Wen


Contact details

Laman Baiduri
Jalan SS12/1
Wangsa Baiduri
Subang Jaya

Additional identifiers

EudraCT number number

Protocol/serial number


Study information

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 hypothesis

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

Local ethics board in Hospital Universiti Sains Malaysia (JEPeM), 21/11/2016, ref: USM/JEPeM/16060218

Study design

Single-center prospective single-blinded comparative study

Primary study design


Secondary study design

Non randomised study

Trial setting


Trial type


Patient information sheet

Not available in web format, please use the contact details to request a patient information sheet


Skin graft donor site wounds


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



Drug names

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 trial start date


Overall trial end date


Reason abandoned (if study stopped)


Participant 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

Participant type


Age group




Target number of participants


Participant 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)

Recruitment start date


Recruitment end date



Countries of recruitment


Trial participating centre

Hospital Universiti Sains Malaysia
Department of Reconstructive Sciences Kubang Kerian, Kelantan

Sponsor information


Hospital Universiti Sains Malaysia

Sponsor details

Department of Reconstruction Sciences
Universiti Sains Malaysia
Kubang Kerian
Kota Bharu

Sponsor type

Hospital/treatment centre



Funder type


Funder name

Universiti Kebangsaan Malaysia

Alternative name(s)

National University of Malaysia

Funding Body Type

government organisation

Funding Body Subtype

Local government



Results and Publications

Publication and dissemination plan

To submit to BioMed Central Complementary and Alternative Medicine Journal.

IPD sharing statement
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.

Intention to publish date


Participant level data

Available on request

Basic results (scientific)

Publication list

1. 2018 results in:

Publication citations

Additional files

Editorial Notes

15/10/2018: Publication reference added.