Efficacy in Preventing Hypertrophic Scars: A Randomised Controlled Trial Comparing Chitosan Cream, Silicone Gel & Olive Oil
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 120
- 试验地点
- 6
- 主要终点
- Patient and Observer Scar Assessment Scale (POSAS) scores
研究概览
简要总结
The goal of this clinical trial is to compare the efficacy of three different topical applications in preventing hypertrophic scars in adults with scars healed after suturing. The main question it aims to answer is: Is Chitosan cream effective in preventing hypertrophic scars?
Researchers will compare Chitosan cream with silicone gel and olive oil to see if there is any difference in their efficacies.
Participants will be randomly assigned to three groups, with each group using a different topical application. They will be instructed to:
- apply the topical application on their scar twice a day for 8 weeks
- attend follow-up visits at 4, 12 and 24 weeks for a doctor to assess their scar and take clinical photographs
- immediately inform the researcher if they experience any side effects
详细描述
This is a 3-arm single-blinded randomised controlled trial to study the efficacy of three topical applications in preventing hypertrophic scars. The general objective is to investigate the efficacy of Chitosan cream in preventing hypertrophic scars compared to other topical applications commonly used; silicone gel and olive oil. The hypothesis is that Chitosan cream shows comparable efficacy in preventing hypertrophic scars compared to silicone gel and olive oil.
The study population consists of patients who had traumatic or surgical scars that have healed by primary intention in the Unit of Reconstructive Sciences, Hospital Pakar USM, Plastic & Reconstructive Surgery Unit of Hospital Raja Perempuan Zainab II and the Plastic & Reconstructive Surgery Department of Hospital Kuala Lumpur and have met the study inclusion criteria.
Patients who meet the inclusion criteria will be given a topical application (Chitosan cream / silicone gel / olive oil) which is assigned randomly by computer software (SPSS version 29). The topical applications is to be applied twice daily from the 14th day since wounding. The investigator will be blinded to the topical application given to the patient. Both patient and investigator will assess the scar using Patient & Observer Scar Assessment Scale (POSAS) version 3.0 and scars will be photographed under fixed camera settings & lighting conditions. Patients will come for follow-up on weeks 4, 12 & 24 and the scar assessment will be repeated by both patient & the same observer. Serial photographs will also be taken each visit. At the end of the 24 weeks, photographs of the scars will be reviewed by three independent plastic surgeons and scored using the Scar Cosmesis & Assessment Rating (SCAR) Scale. Both the scores from the clinical & photographic scar assessments will be evaluated to compare the efficacy of each topical application. The duration of the study is from Nov 2025-Nov 2026.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with traumatic or surgical wounds which have healed by primary intention within 14 days
- •Length of scar at least 3cm
排除标准
- •Patients with seafood allergy
- •Patients with scar from wounds that were complicated by infection or wound breakdown
- •Patients who have undergone scar treatment by other modalities
- •Patients with history of keloids / hypertrophic scars
- •Pregnant patients
结局指标
主要结局
Patient and Observer Scar Assessment Scale (POSAS) scores
时间窗: Enrolment to 24 weeks
Each item is rated on a 5-point score. The lowest score is '1' which corresponds to the situation of normal skin. Score '5' being the largest difference from normal skin.
Scar Assessment and Rating (SCAR) Scale scores
时间窗: Enrolment to 24 weeks
Scores of clinical photographs of each scar by 3 plastic surgeons. Score '0' indicates conditions closest to normal skin. Maximum scores for each item range from 1 to 4, where higher scores indicate larger differences from normal skin.
次要结局
- Side effects(Enrolment to 24 weeks)
研究者
Esther Tan Hui Min
Dr
Universiti Sains Malaysia