Comparing Chitosan Sponge With Hydrocolloid as Dressing for Split-thickness Skin Graft Donor Site Wounds

NCT07472465 | Completed DMC

• 1 other identifier: USM/JEPeM/KK/23120941
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to compare whether chitosan sponge have same clinical efficacy as a hydrocolloid dressing in treating skin graft donor site wounds. The main questions it aims to answer are: Does chitosan sponge show comparable clinical efficacy as a split-thickness skin graft donor site dressing compared with a conventional hydrocolloid dressing? Participants will: The skin graft donor site wound will be divided into equal halves, and a chitosan sponge and hydrocolloid dressing will be applied to the same patient. The rate of epithelialization will be assessed on days 10, 15, and 20 pain score, pruritus score, ease of removal, exudate level, and bleeding will be assessed on days 10, 15, and 20 The scar outcome will be assessed 2 months and 6 months post-procedure

Conditions

Skin Graft Wounds

Outcome Measures

Primary Outcomes (1)

• Rate of epitheliazation

  To compare the rate of epithelization of STSG donor site using chitosan sponge and conventional hydrocolloid dressing. Visual assessment will be done according to percentage of wound surface epithelized as well as objective percentage with grid film is applied to avoid biasness

  enrollment till 20 days

Secondary Outcomes (2)

• compatibility of dressing

  from enrollment till 20 days

• scar outcome

  from enrollment till 6 months

Study Arms (2)

Chitosan Group

ACTIVE COMPARATOR

chitosan dressings will be applied

Device: Chitosan

hydrocolloid group

ACTIVE COMPARATOR

hydrocolloid dressing will be applied

Device: Hydrocolloid Dressing (DuoDERM CGF)

Interventions

Chitosan DEVICE

sponge type of dressing made of chitosan

Chitosan Group

Hydrocolloid Dressing (DuoDERM CGF) DEVICE

hydrocolloid type of dressing

hydrocolloid group

Eligibility Criteria

• Age: 12 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• All patients with partial thickness wounds after split thickness skin graft harvesting
• Skin graft donors \> 50cm2 wide
• Age \> 12 years old
• Consented patients
• Patients compliant to the treatment protocol

You may not qualify if:

• Non-compliant patient, causing dressing to dislodge
• Patient with history of allergy to seafood
• Pregnancy

Sponsors & Collaborators

• Hospital Universiti Sains Malaysia: lead

Study Sites (1)

Hospital Pakar Universiti Sains Malaysia

Kota Bharu, Kelantan, 16150, Malaysia

Location

Related Publications (3)

• Jayakumar R, Prabaharan M, Sudheesh Kumar PT, Nair SV, Tamura H. Biomaterials based on chitin and chitosan in wound dressing applications. Biotechnol Adv. 2011 May-Jun;29(3):322-37. doi: 10.1016/j.biotechadv.2011.01.005. Epub 2011 Jan 22.

  PMID: 21262336 BACKGROUND

• Varon DE, Smith JD, Bharadia DR, Shafique N, Sakthivel D, Halvorson EG, Nuutila K, Sinha I. Use of a novel chitosan-based dressing on split-thickness skin graft donor sites: a pilot study. J Wound Care. 2018 Jul 1;27(Sup7):S12-S18. doi: 10.12968/jowc.2018.27.Sup7.S12.

  PMID: 30008255 RESULT

• Stone CA, Wright H, Clarke T, Powell R, Devaraj VS. Healing at skin graft donor sites dressed with chitosan. Br J Plast Surg. 2000 Oct;53(7):601-6. doi: 10.1054/bjps.2000.3412.

  PMID: 11000077 RESULT

Related Links

• Meta-analysis and Systematic Review of Skin Graft Donor-site Dressings with Future Guidelines
• Randomized clinical trial of donor-site wound dressings after split-skin grafting

MeSH Terms

Interventions

Bandages, Hydrocolloid

Intervention Hierarchy (Ancestors)

Bandages; Equipment and Supplies

Study Officials

• MING CHIN LIM, MBBS

  Universiti Sains Malaysia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 9, 2026
• First Posted: March 16, 2026
• Study Start: May 1, 2024
• Primary Completion: May 30, 2025
• Study Completion: July 1, 2025
• Last Updated: March 16, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

MY (1)