Clinical Efficacy of Chitosan Sponge Compared With Conventional Hydrocolloid Dressing in Managing Skin Graft Donor Sites: A Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 22
- 试验地点
- 1
- 主要终点
- Rate of epitheliazation
研究概览
简要总结
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
详细描述
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:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 12 Years 至 99 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •Non-compliant patient, causing dressing to dislodge
- •Patient with history of allergy to seafood
- •Pregnancy
研究组 & 干预措施
Chitosan Group
chitosan dressings will be applied
干预措施: Chitosan (Device)
hydrocolloid group
hydrocolloid dressing will be applied
干预措施: Hydrocolloid Dressing (DuoDERM CGF) (Device)
结局指标
主要结局
Rate of epitheliazation
时间窗: 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
次要结局
- compatibility of dressing(from enrollment till 20 days)
- scar outcome(from enrollment till 6 months)
研究者
Lim Ming Chin
Principal Investigator
Hospital Universiti Sains Malaysia