Clinical Efficacy of Chitosan Sponge Compared With Conventional Hydrocolloid Dressing in Managing Skin Graft Donor Sites: A Clinical Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 22
- Locations
- 1
- Primary Endpoint
- Rate of epitheliazation
Study Overview
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
Detailed Description
Data Collection:
This is a prospective, single-blinded, comparative controlled-matched clinical trial involving patients in Hospital Pakar Sains Malaysia with partial thickness wounds created as a result of split-thickness skin graft harvest. Any patient requiring skin grafting and fulfilling the inclusion criteria will be approached preoperatively for recruitment in the study. Patients' donor site wounds will then be divided horizontally into two equal halves (superior and inferior) and dressed using chitosan sponge (Myplas® Sponge from Chitoplast Sdn. Bhd.) and hydrocolloid dressing (Elect Hydro™, Smith & Nephew) respectively, whereby the order for application of these 2 dressings will be randomised using https://www.randomizer.org/. The CONSORT statement for clinical trials is referred to during protocol development.
Patient consent:
Written informed consent will be obtained from all patients after counselling and understanding the information sheet given. For patients below 18 years of age, consent will be obtained from their legal guardian.
Sample size estimation:
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 12 Years to 99 Years (Child, Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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
Exclusion Criteria
- •Non-compliant patient, causing dressing to dislodge
- •Patient with history of allergy to seafood
- •Pregnancy
Arms & Interventions
Chitosan Group
chitosan dressings will be applied
Intervention: Chitosan (Device)
hydrocolloid group
hydrocolloid dressing will be applied
Intervention: Hydrocolloid Dressing (DuoDERM CGF) (Device)
Outcomes
Primary Outcomes
Rate of epitheliazation
Time Frame: enrollment till 20 days
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
Secondary Outcomes
- compatibility of dressing(from enrollment till 20 days)
- scar outcome(from enrollment till 6 months)
Investigators
Lim Ming Chin
Principal Investigator
Hospital Universiti Sains Malaysia