A Pilot Study Comparing Cutaneous Scarring When Scalpel Versus Cautery is Used to Make Skin Incisions
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 4
- 试验地点
- 2
- 主要终点
- The primary outcome measure is the Vancouver Scar Scale
研究概览
简要总结
Cutaneous scarring after elective surgery is a concern for surgeons of all types, perhaps even more so to plastic surgeons. Cautery is often used on the "cut" setting to make or extend incisions; however very few studies have looked at the results of these scars. The investigators' study aims are to compare standard scalpel incisions versus cautery incisions and to objectively compare the resultant scars in a prospective, randomized, controlled fashion.
详细描述
Rationale: Most surgeons at some point have used the "cut" setting on a cautery device to make or extend an incision. Anecdotally, there does not appear to be a noticeable difference in the scarring. This opinion, however is not shared by all surgeons.
Review of the literature reveals a paucity of evidence supporting the use of cutting cautery vs. standard, scalpel incision. A study that objectively, prospectively, and randomly compares the scars between these two methods has the potential to alter the doctrine of scalpel incisions, potentially saving money, and allowing a safer operating room environment (one free of scalpels in some cases).
Objectives: To objectively compare the cutaneous scars resulting from scalpel versus cutting cautery incisions using a subjective and objective scar measurement tool.
Methodology:
Research Design: This study will be a Blinded, Prospective, Randomized Controlled Trial.
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 (Participant)
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
- •Inclusion Criteria:
- •Patients undergoing primary, elective panniculectomy.
- •Patients must voluntarily be enrolled in the study after informed consent.
- •Patients must be in relative good health and have adequate nutrition.
- •Patients of all races and genders will be included.
- •Patients must agree to refrain from the use of topical scar products during the study period.
排除标准
- •Under the age of 18 years old
- •Patients with previous history of hypertrophic or keloid scarring
- •Patients presenting for scar revision
- •Patients presenting for a non-elective surgery
- •Patients with chronic immunosuppression or wound healing problems
- •Currently taking medications that interfere with wound healing such as corticosteroids, anti-coagulants (aspirin or NSAIDs), vasoconstricting agents (adrenaline or ergotrate), anti-cancer drugs, or colchicine for gout,
- •Use of any tobacco products
结局指标
主要结局
The primary outcome measure is the Vancouver Scar Scale
时间窗: 12 months
次要结局
- Visual scar scale done by both the subject and an independent observer(12 months)