Aesthetic Outcome of Electrodesiccation and Curettage vs Excision With Complex Linear Closure for Low Risk Lesions on the Trunk and Extremities: a Randomized, Blind Control Trial
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 59
- 试验地点
- 2
- 主要终点
- Scar Assessment
研究概览
简要总结
The purpose of this study is to determine whether electrodesiccation and curettage (ED&C) versus excision with complex linear closure affects esthetic outcomes (primary outcome). As secondary outcome, we plan to look at patient quality of life measures and complications. This will be a prospective, 2-arm, randomized, evaluator-blinded clinical trial. One half of the patients will receive ED&C and the other half will receive excision with repair by complex linear closure. Three-months post-surgery, the scar will be evaluated via the patient observer scar assessment scale (POSAS), a validated scar instrument, as well as the trace-to-tape method, an objective outcome measure for linear postoperative scars. In addition, patients will be provided a validated quality of life survey to complete. Any adverse events will also be recorded.
详细描述
Low risk lesions on the trunk and extremities can be treated via various modalities including topical therapies, ED&C, and excision. The purpose of this study is to compare ED&C versus excision with repair by complex linear closure. The wound following ED&C will heal by second intention, meaning that there will not be any sutures placed. Complex linear closures following an excision will require two layers of sutures: a deep (subcutaneous) layer and a top (cutaneous) layer.
This study aims to investigate whether ED&C versus excision with repair by complex linear closure for low risk lesions on trunk and extremities affects cosmesis. In other words, the research team would like to determine which of the following yields a more cosmetically appealing scar: ED&C or excision with linear closure. As secondary outcomes, the research team plans to look at quality of life measures via a validated survey and complications.
There has been a prospective cohort study measuring quality of life following ED&C vs excision vs Mohs surgery1 and another prospective cohort study measuring patient reported outcomes following ED&C2. However, randomized control trials comparing the cosmesis and quality of life of these two methods appear to be lacking in current literature. The research team hopes that this study will provide new insight in cutaneous surgery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 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
- 否
入选标准
- •18 years of age or older
- •Able to give informed consent themselves
- •Patient scheduled for treatment of low risk cutaneous neoplasms on the trunk or extremities (superficial or nodular basal cell carcinoma and squamous cell carcinoma in-situ).
- •Willing to return for follow up visit
排除标准
- •Incarceration
- •Under 18 years of age
- •Pregnant Women
- •Lesion size equal to or greater than 2 cm.
- •Aggressive tumor subtypes(invasive squamous cell carcinoma (any subtype), infiltrative(sclerosing) basal cell carcinoma, micronodular basal cell carcinoma.
- •Recurrent tumors
结局指标
主要结局
Scar Assessment
时间窗: 3-12 months
The primary endpoints will be (1) the score of two blinded reviewers using the patient observer scar assessment score and (2) the mean scar area to preoperative cancer area ratio using the trace-to-tape method at a three-month assessment visit.
次要结局
- Complications(3-12 months)
- Quality of Life Measures (DLQI)(3-12 months)