Undermining Apices in Surgical Wounds: a Randomized Evaluator-blinded Split-wound Comparative Effectiveness Trial
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Observer Scar Assessment as measured by Patient Observer Scar Assessment Score (POSAS)
研究概览
简要总结
When patients have surgery on the neck, trunk, arms, or legs, stitches are the standard way to close the wound. Wounds always result in a scar, but doctors are always looking for ways to reduce scarring. Several studies have been done to test ways to close wounds that reduce scarring. One idea is to reduce the tension around the cut. One way to reduce tension is to free up the skin around the wound. This procedure is also called "undermining". Some studies have shown that freeing up the skin near the tips of the wound, called the "apices," is helpful for improving the cosmetic outcome of scars. This study will investigate if there are any differences in the appearances of the scar if one tip is undermined and the other is not.
详细描述
Reducing scar tissue formation and postoperative complications in wound closure has remained the focus of recent studies and decreases the cost and time burden of follow-up visits and procedures. Such studies have highlighted the impact of mechanical forces and tension on scar formation, demonstrating that reducing the mechanical stress within the wound environment results in better aesthetic outcomes. Undermining peripheral and apices of the wound has been used in the closure of large and tight defects allowing the closure of these wounds by reducing the tension. Undermining has been shown to reduce tension, and peripheral and apical undermining has been recommended for decreasing scar formation. However, extensive undermining may increase the complications of the surgery by reducing vascularization and creating a space for hematomas. To our knowledge, the impact of scar cosmesis and the rate of postoperative complications in apical undermining in the linear repair of surgical wounds have not been studied, and it remains unknown whether undermining the apices can decrease the protrusion of the scar tissue at the edges. This study seeks to determine the effectiveness of apical undermining of linear wound closures in improving scar cosmesis by using individuals as their own controls in a split-scar model.
This is a single center, randomized, evaluator-blinded, split wound study.
After screening and informed consent, demographic data will be collected including age, race, gender, and medical record number. This will be collected within the Redcap database.
The patient's wound will be labeled A if it is on the left or superior side of the investigator and B if it is on the right or inferior side. A concealed randomization result will be obtained from the Redcap randomization module, which will specify which side, A or B, will receive apical undermining
Following this, both sides of the wound will be sutured together with a subcutaneous (bottom) layer of stitches. Next, a cutaneous layer of sutures will be placed, as is the standard of care. A digital image of the wound after the epidermal closure will be obtained; these may be used in scientific talks and/or for publication purposes. The patient will then be instructed to continue dressing changes along the entire length of the surgical site until the wound is fully healed as is the standard of care.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Other
- 盲法
- Single (Outcomes Assessor)
盲法说明
Two blinded observers will record their scores independently using the POSAS instrument.
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 cutaneous surgical procedure on the neck, trunk, and extremities with predicted primary closure
- •Willing to return for follow-up visit
排除标准
- •Incarceration
- •Under 18 years of age
- •Pregnant women
- •Unable to understand written and oral English
- •Wounds with predicted closure length less than 3cm
研究组 & 干预措施
Linear Wound Closure
A cutaneous layer of sutures will be placed on one side, as is standard of care.
Linear Wound Closure with Apical Undermining
The other side of the wound will have a cutaneous layer of sutures, as is standard of care, and will receive apical undermining.
干预措施: Apical Undermining (Other)
结局指标
主要结局
Observer Scar Assessment as measured by Patient Observer Scar Assessment Score (POSAS)
时间窗: 3 months
The primary endpoint will be the score of two blinded reviewers independently using the POSAS assessment. The observer scale of the POSAS consists of six items (vascularity, pigmentation, thickness, relief, pliability, and surface area). All items are scored on a scale ranging from 1 ("like normal skin") to 10 ("worst scar imaginable"). The sum of the six items results in a total score of the POSAS observer scale. Furthermore, an overall opinion is scored on a scale ranging from 1 to 10. All parameters should preferably be compared to normal skin on a comparable anatomic location.
次要结局
- Width of Scar as measured using Trace-to-Tape Method(3 months)
- Patient Scar Assessment as measured by Patient Observer Scar Assessment Score (POSAS)(3 months)
- Complications or Adverse Events from Treatment(3 months)
研究者
Daniel Eisen, MD
Professor of Clinical Dermatology, Director of Dermatologic Surgery
University of California, Davis