Effect of Replacing Buried Sutures With Tissue Adhesive on Aesthetic Outcome of Surgical Wounds.
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- Rating the healing progression of the wound
研究概览
简要总结
Surgery wounds are typically closed with combination of absorbable stitches placed under the skin and non-absorbable stitched placed at the skin surface. Absorbable sutures can produce unwanted side effects when the body produces a reaction to them. The investigators are conducting a study to determine if absorbable stitches can be replaced but tissue glue applied on the surface of the skin. If participants enroll in the study, the investigators will close one half of the participants wound with absorbable stitches placed under the skin and non-absorbable stitches on the surface. The other half of the wound will be closed with non-absorbable stitches and tissue glue. The appearance of the scar (if any) will then be evaluated at 3- and 6-month follow-ups by two dermatologists (either board-certified dermatologists or dermatology residents) and the patient.
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)
盲法说明
The efficacy of intervention methods will be assessed at the 3 month and 6 month follow-ups by having the patient and two blinded observers rate the healing progression of the wound using the POSAS. The observers will be either dermatology faculty or dermatology. The POSAS is a standard metric in measuring wound healing in cutaneous surgery studies since it does not require training but takes into account the scar assessment of the patient and observers. Subsequently, the height and width of the scar will be measured and compared to the surrounding unaffected skin. The assessments of the two blind observers will be averaged.
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
- •Age 18 years or older
- •Postoperative defects of at least 3 cm, resulting from either Mohs micrographic surgery or surgical excision
- •Willing to give informed consent and return for follow-up visits 3 months and 6 months following surgery
排除标准
- •Unable to understand English
- •Mentally impaired
- •Incarcerated
- •Has nonlinear closures
研究组 & 干预措施
Wound Side A: buried sutures, Wound Side B: tissue adhesive
Wounds halves will be labeled as A (left/superior) or B (right/inferior), the halves will be randomized to receive either tissue glue or deep sutures.
干预措施: Closure of surgical wounds using buried sutures or tissue adhesive on aesthetic outcome. (Procedure)
Wound Side A: tissue adhesive, Wound Side B: buried sutures
Wounds halves will be labeled as A (left/superior) or B (right/inferior), the halves will be randomized to receive either tissue glue or deep sutures.
干预措施: Closure of surgical wounds using buried sutures or tissue adhesive on aesthetic outcome. (Procedure)
结局指标
主要结局
Rating the healing progression of the wound
时间窗: 6 months after surgical wound closure
By observation using the Patient-Observer Scar Assessment Scale (POSAS)
次要结局
未报告次要终点
研究者
Michael Kolodney
Dermatology Section Chief
West Virginia University