Scar Appearance After Postoperative Hydrocolloid Dressing Versus Standard Petrolatum Ointment: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 146
- 试验地点
- 1
- 主要终点
- Cosmetic Outcome
研究概览
简要总结
Patients will be randomized either to receive standard daily dressing or hydrocolloid dressing using a randomization generator. After closing the wound with the sutures,the scar will be covered by a hydrocolloid dressing, which will be left in place for 7 days(Experimental) or the standard dressing (Control) that will be covered with petrolatum jelly and bandaging during this time period, which has to be re-applied daily. Patients and dermatologic surgeons will then complete surveys 7 days, 30 days, and 90 days after surgery to evaluate the cosmetic appearance of these scars.
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
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Adult > 18 years of age
- •Linear scars
- •Patients underwent conventional excision or Mohs micrographic surgery for primary cutaneous cancer or other cutaneous condition that required surgical intervention
排除标准
- •Scar localization on acral or hair bearing sites
- •Patients unable to converse in English
- •Patients requiring flap or graft for closure of wound
- •History of allergy to adhesives
- •Patient using topical chemotherapy agents on the surgical site or planning to start it within 3 months after surgery
- •Use of hydrocolloid dressings for post-operative wound care in the past
研究组 & 干预措施
hydrocolloid dressing arm
After informed consent and closing the wound with the sutures, the scar will be covered by a hydrocolloid dressing, which will be left in place for 7 days (Experimental)
干预措施: Hydrocolloid dressing (Device)
Petrolatum jelly dressing arm
and the other group of patients (control), after closing the wound with the sutures, the scar will be covered with petrolatum jelly during this time period, which has to be re-applied daily.
干预措施: Petrolatum jelly dressing (Other)
结局指标
主要结局
Cosmetic Outcome
时间窗: 90 days
Patient and surgeon assessment of cosmetic outcome using modified visual analogue scar scale. The minimum value is 1 and the maximum value is 10. 1 is the worst possible scar appearance and 10, is the best possible scar appearance.
Cosmetic Outcome
时间窗: 7 days
Patient and surgeon assessment of cosmetic outcome using modified visual analogue scar scale. The minimum value is 1 and the maximum value is 10. 1 is the worst possible scar appearance and 10, is the best possible scar appearance.
Cosmetic Outcome
时间窗: 30 days
Patient and surgeon assessment of cosmetic outcome using modified visual analogue scar scale. The minimum value is 1 and the maximum value is 10. 1 is the worst possible scar appearance and 10, is the best possible scar appearance.
次要结局
- Number of Participants With Complications(7 days, 30 days, 90 days)
研究者
Syril Keena Que
Assistant Professor of Clinical Dermatology
Indiana University