Use of 6-0 Fast Absorbing Gut Versus 5-0 Fast Absorbing Gut for Linear Cutaneous Wound Closure: a Randomized Evaluator Blind Split Wound Comparative Effectiveness Trial.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 50
- 主要终点
- Scar Assessment
研究概览
简要总结
Traditionally, dermatologic surgeons close wounds with stitches. Fast absorbing gut is a dissolvable stitch that is very commonly used. Some surgeons believe that using a thinner size of this stitch causes less skin reaction and improves the cosmetic outcome of the scar. Other surgeons believe that using a thicker size of this stitch reduces the tension on the scar and improves the cosmetic outcome of the scar in that manner. The investigator wishes to determine whether the thickness of the fast absorbing gut suture that is used makes a difference in the cosmetic outcome of the scar.
详细描述
The purpose of this study is to determine whether the use of 6-0 fast absorbing gut during repair of linear cutaneous surgery wounds on the face or neck improves scar cosmesis compared to wound closure with 5-0 fast absorbing gut. The investigator will use a split wound model, where half of the wound is repaired with 6-0 fast absorbing gut and the other half is repaired with 5-0 fast absorbing gut. Three-months post-surgery, the scar will be measured via the patient observer scar assessment scale, a validated scar instrument. The scar width, and adverse events will also be recorded.
This study aims to investigate whether 5-0 versus 6-0 fast absorbing gut suture leads to better surgical wound cosmesis on the head and neck. The 5-0 fast absorbing gut suture has a large diameter, and therefore greater tensile strength. The greater tensile strength would provide better support of the healing scar during the first 5-7 days after surgery and for this reason, could potentially lead to improved scar cosmesis. However, the greater diameter could also lead to track marks that are larger and more visible. Furthermore, fast absorbing gut has a high degree of tissue reactivity to begin with, and it is known that larger diameter sutures generate more tissue reactivity compared to smaller diameter sutures of the same material; therefore, it is also possible that the 6-0 fast absorbing gut suture would provide better scar cosmesis by virtue of its lower tissue reactivity3,4.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Factorial
- 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 cutaneous surgical procedure on the head and neck with predicted primary closure
- •Willing to return for follow up visit.
排除标准
- •Mentally handicapped
- •Unable to understand written and oral English
- •Incarceration
- •Under 18 years of age
- •Pregnant Women
- •Wounds with predicted closure length less than 3 cm
研究组 & 干预措施
6-0 fast absorbing gut suture
6-0 fast absorbing gut used to suture wound
干预措施: 6-0 fast absorbing gut suture (Device)
5-0 fast absorbing gut suture
5-0 fast absorbing gut used to suture wound
干预措施: 5-0 fast absorbing gut suture (Device)
结局指标
主要结局
Scar Assessment
时间窗: 3 months following the procedure
The primary endpoint will be the score of two blinded reviewers using the patient observer scar assessment score at a three-month assessment visit.
次要结局
- Width of the Scar(3 months following the procedure)
