Condition category
Not Applicable
Date applied
11/01/2018
Date assigned
16/02/2018
Last edited
18/01/2018
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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

Type

Public

Primary contact

Dr Adzim Poh Yuen Wen

ORCID ID

http://orcid.org/0000-0002-0903-6152

Contact details

A-3-3
Laman Baiduri
Jalan SS12/1
Wangsa Baiduri
Subang Jaya
47500
Malaysia

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

USM/JEPeM/16060218

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

Acronym

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

Interventional

Secondary study design

Non randomised study

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

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

Condition

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

Phase

Drug names

Primary outcome measures

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

01/08/2016

Overall trial end date

04/09/2017

Reason abandoned

Eligibility

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

Patient

Age group

Mixed

Gender

Both

Target number of participants

25

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

29/12/2016

Recruitment end date

03/07/2017

Locations

Countries of recruitment

Malaysia

Trial participating centre

Hospital Universiti Sains Malaysia
Department of Reconstructive Sciences Kubang Kerian, Kelantan
16150
Malaysia

Sponsor information

Organisation

Hospital Universiti Sains Malaysia

Sponsor details

Department of Reconstruction Sciences
Universiti Sains Malaysia
Kubang Kerian
Kelantan
Kota Bharu
16150
Malaysia

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

University/education

Funder name

Universiti Kebangsaan Malaysia

Alternative name(s)

National University of Malaysia, UKM

Funding Body Type

government organisation

Funding Body Subtype

government non-federal

Location

Malaysia

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

18/03/2018

Participant level data

Available on request

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes