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临床试验/NCT03327922
NCT03327922已完成不适用

Interrupted Subdermal Suture Spacing During Linear Wound Closures and the Effect on Wound Cosmesis: a Randomized Evaluator Blinded Split Wound Comparative Effectiveness Trial

University of California, Davis1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2017年9月20日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
50
试验地点
1
主要终点
Patient and Observer Scar Assessment Scale - Reviewer 1

研究概览

简要总结

This study aims to investigate whether the spacing of the interrupted deep (subdermal) sutures affects surgical wound cosmesis on the trunk and extremities. In other words, the investigator would like to determine which of the following yields a more cosmetically appealing scar: many closely approximated subdermal sutures or fewer, more widely spaced subdermal sutures. The investigator wishes to compare the effects of one versus two centimeter spacing between sutures.

详细描述

Sutures are the standard of care in repairing cutaneous wounds. The majority of surgical reconstructions following a Mohs micrographic surgery and standard surgical excisions require two layers of sutures: a deep layer and a top layer. The deep layer dissolves naturally whereas the top layer must be removed.

This study aims to investigate whether the spacing of the interrupted deep (subdermal) sutures affects surgical wound cosmesis on the trunk and extremities. In other words, the investigator would like to determine which of the following yields a more cosmetically appealing scar: many closely approximated subdermal sutures or fewer, more widely spaced subdermal sutures. The investigator wishes to compare the effects of one versus two centimeter spacing between sutures. It is possible that fewer, more widely spaced sutures may leave more open space in the wound, leaving more tension to pull on those few sutures, possibly encouraging the wound to dehisce and make it harder to approximate the wound edges yielding a less cosmetically appealing scar compared to placing many closely approximated sutures which would decrease the tension and likely better approximate the wound edges yielding a more cosmetically appealing scar. On the other hand, we may find that suture spacing has no effect on wound cosmesis and that placing fewer, more widely spaced sutures is much more time efficient. The investigator may also find that the effect of suture spacing on wound cosmesis is dependent on wound tension. For example, perhaps the suture pacing would have no effect on the cosmesis of a wound under no tension, however, for a wound under high tension, it is possible that many closely approximated sutures would yield better cosmetic results for the reasons listed above.

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)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 18 years of age or older
  • Able to give informed consent themselves
  • Patient scheduled for cutaneous surgical procedure on the trunk and extremities 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 4 cm

研究组 & 干预措施

Vicryl absorbable suture placed 2 cm apart

Experimental

Wound closed with sutures spaced 2 centimeters apart will be treated in a simple, interrupted subdermal suture pattern

干预措施: Vicryl absorbable suture (Device)

Vicryl absorbable suture placed 1 cm apart

Experimental

Wound closed with sutures spaced 1 centimeter apart will be treated in a simple, interrupted subdermal suture pattern

干预措施: Vicryl absorbable suture (Device)

结局指标

主要结局

Patient and Observer Scar Assessment Scale - Reviewer 1

时间窗: 3 months following procedure

The primary endpoint will be the score of two blinded reviewers using the patient observer scar assessment score (POSAS). The POSAS measures scar quality in all types of scars by evaluating visual (e.g. color), tactile (e.g. pliability) and sensory (e.g. itch) characteristics of the scar from the perspective of the observer and patients. Scores for each subscale range from 1 to 10, for a sum score range from 6 to 60. Low scores indicate better outcomes.

Patient and Observer Scar Assessment Scale - Reviewer 2

时间窗: 3 months following procedure

The primary endpoint will be the score of two blinded reviewers using the patient observer scar assessment score (POSAS). The POSAS measures scar quality in all types of scars by evaluating visual (e.g. color), tactile (e.g. pliability) and sensory (e.g. itch) characteristics of the scar from the perspective of the observer and patients. Scores for each subscale range from 1 to 10, for a sum score range from 6 to 60. Low scores indicate better outcomes.

次要结局

  • Width of Scar(3 months following procedure)
  • Complications(3 months following procedure)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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