Comparison of Fast-Absorbing Sutures for Mohs Surgery Repair on the Face (ComFAS): a Randomized Controlled Split-scar Study
试验速览
- 阶段
- 早期 1 期
- 入组人数
- 100
- 主要终点
- The Stony Brook Scar Evaluation Scale (SBSES) score (cosmetic outcome)
研究概览
简要总结
This study is being carried out to assess equivalence of scar outcome for two absorbable sutures used for wound closure on the face in dermatologic surgery: rapidly absorbable polyglactin 910 (VicrylRapide™) and fast-absorbing plain gut (5-0 fast). This is important because absorbable sutures are commonly used in Mohs surgery for epidermal closure, yet there is no evidence indicating if any of the sutures above allow for a better cosmetic outcome (less erythema, edema, and scarring).
详细描述
Prospective randomized controlled split-scar observer-blinded study.
After dermatologic surgery on the face, surgeons have a choice between using non-absorbable or absorbable sutures for skin closure. A dermatologic surgeon favoring absorbable sutures for wound closure will consider many factors in material selection, including ease of manipulation, cost, and absorption time. However, there have been no randomized trials comparing the most important measure: aesthetic/cosmetic outcome.
Study endpoint/outcome: use three validated scar assessment tools.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Single (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
- •Patients who are over 18 years and are having Mohs surgery on the face.
排除标准
- •Patients with surgical wounds less than 4cm in length
- •Patients requiring full thickness skin grafts for reconstruction
- •Patients who are unable to attend routine postoperative follow-up appointments
- •Patients who are receiving radiation therapy after surgery.
结局指标
主要结局
The Stony Brook Scar Evaluation Scale (SBSES) score (cosmetic outcome)
时间窗: 6 months
In this study we will use three validated scar assessment tools (the Stony Brook Scar Evaluation Scale (SBSES) to assess scar width, height, color, cross-hatching and overall appearance, the Wound Evaluation Scale (WES) to rate scar stepoff, contour irregularity, scar width, edge inversion, and inflammation , and the Visual Analogue Scale (VAS)) to assess overall scar appearance. This will be done at the one-week, two-month and six-month post-operative follow-ups.
The Visual Analogue Scale (VAS) score (cosmetic outcome)
时间窗: 6 months
In this study we will use three validated scar assessment tools (the Stony Brook Scar Evaluation Scale (SBSES) to assess scar width, height, color, cross-hatching and overall appearance, the Wound Evaluation Scale (WES) to rate scar stepoff, contour irregularity, scar width, edge inversion, and inflammation , and the Visual Analogue Scale (VAS)) to assess overall scar appearance. This will be done at the one-week, two-month and six-month post-operative follow-ups.
The Wound Evaluation Scale (WES) score (cosmetic outcome)
时间窗: 6 months
In this study we will use three validated scar assessment tools (the Stony Brook Scar Evaluation Scale (SBSES) to assess scar width, height, color, cross-hatching and overall appearance, the Wound Evaluation Scale (WES) to rate scar stepoff, contour irregularity, scar width, edge inversion, and inflammation , and the Visual Analogue Scale (VAS)) to assess overall scar appearance. This will be done at the one-week, two-month and six-month post-operative follow-ups.
次要结局
未报告次要终点