COEBICS: Comparison of Erythema Between Interrupted and Continuous Sutures
试验速览
- 阶段
- 不适用
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Change in the Intensity of Scar Erythema
研究概览
简要总结
This is a randomized, controlled, prospective study which relies on computer-assisted skin image processing of scar photographs, to establish whether simple interrupted or running sutures are associated with the greatest degree of erythema when used to repair surgical defects arising from Moh's micrographic surgery (MMS) of facial skin cancers. Furthermore, through the use of the customized software that the investigators have developed for this purpose, an effort will be made to better understand the evolution (including progression and subsequent regression) of erythema over time in these scars.
详细描述
Purpose: This is a randomized, controlled, prospective split-scar study which employs computer-assisted image processing to establish whether simple interrupted or running sutures cause the greatest degree of erythema in the surgical scars resulting from Moh's micrographic surgery (MMS), and to better understand the evolution (including progression and subsequent regression) of erythema over time in these scars.
Hypothesis: Based on the literature review and the clinical experience of the investigators, it is hypothesized that the quantified difference in persisting erythema that is caused by each suturing technique will be minimal and not statistically significant.
Justification: The cosmetic appearance of scars is an important concern for patients undergoing Moh's micrographic surgery (MMS), a specialized therapeutic procedure that is used for high risk skin cancers on the face. Many factors influence the aesthetics of a surgical scar; suturing technique is among the most significant. Simple interrupted stitches and running (continuous) stitches are the two most frequently used suturing techniques. Anecdotal opinions favor one technique over the other. Some authors consider simple interrupted stitches to be more time consuming but allows more precise wound approximation. Other surgeons feel running stitches decrease suture marks. A recent literature search looking at the influence of suturing technique on the cosmetic outcome of scars could not draw any conclusion as to which stitching method should be recommended for facial repair because of the lack of comparative studies. The need for prospective randomized trials in this field is required. Multiple scales have been reported in the literature which can be utilized for cosmetic assessment of healing surgical scars. Persistent scar erythema/dilated peri-scar telangiectasias are a relatively common finding associated with facial surgery and are included as a component in only one of the aforementioned scar evaluation scales. Furthermore, it is only the presence of erythema that is gauged by the scale, and not its intensity or area as these parameters would be challenging to objectively assess. To address this issue, the investigators have developed a software that is capable of quantifying the intensity and area involving erythema in scars. As such, this study has been designed to determine whether simple interrupted or running sutures would cause the greatest degree of erythema and to what extent (both in terms of intensity and area) in the resulting facial MMS scars.
Objectives:
- To determine whether simple interrupted or running sutures cause the greatest degree of persistent erythema in the scars resulting from MMS facial defect repair.
- To determine the percentage difference in the degree of persisting erythema (including intensity and area) caused by each suturing technique.
- To quantitatively assess the evolution of erythema over time in simple interrupted and running sutures to better characterize its patterns of progression and subsequent regression.
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 (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
- •Subjects will be included only if the following conditions are all met:
- •The subject is 18 years of age or older.
- •The subject is presenting with a facial surgical defect after MMS that requires a repair resulting in a scar of more than 4 cm in length.
- •The subject is willing and capable of cooperating to the extent and degree required by the protocol.
排除标准
- •Subjects will be excluded if any of the following conditions are met:
- •The subject has a history of keloidal scarring.
- •The subject will require radiation therapy after surgery.
- •The subject is participating in another investigational drug or device study within 30 days of proposed study enrolment.
- •The subject is not able to fully understand the protocol and consent documents.
结局指标
主要结局
Change in the Intensity of Scar Erythema
时间窗: 1 week, 8 weeks, and 6 months post-operatively
The degree of scar erythema post-operatively will be assessed in each half of each patient's scar by quantifying both the intensity and the surface area of erythema. This will be achieved digitally by employing the customized software developed by the investigators for this purpose.
次要结局
未报告次要终点
研究者
David Zloty
Clinical Professor
University of British Columbia
