跳至主要内容
临床试验/NCT06233812
NCT06233812招募中不适用

Surgical Outcomes of Simple Interrupted Versus Running Epidermal Sutures in Full-thickness Skin Graft Placement: A Split-scar, Randomized, Non-inferiority Comparison

Northwell Health2 个研究点 分布在 1 个国家目标入组 52 人开始时间: 2023年8月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
52
试验地点
2
主要终点
The Patient and Observer Scar Assessment Scale (POSAS)

研究概览

简要总结

The study hypothesis is that the use of running epidermal sutures in full-thickness skin graft (FTSG) placement for patients undergoing dermatologic surgery (Mohs micrographic surgery or excision) is non-inferior to the use of simple interrupted sutures with respect to cosmetic outcome. This will be a split-scar (within-person) study, in which half of each participant's scar will receive the study intervention (running epidermal sutures), with the other half receiving the control intervention (simple interrupted sutures). The primary outcome, total observer score of the Patient and Observer Scar Assessment Scale (POSAS) 2.0, will be assessed by two blinded observers at a 3-month follow-up visit, and compared between scar halves.

详细描述

A FTSG is used in lieu of linear repair or local tissue skin flap rearrangement when surrounding skin tissue laxity is unavailable or the patient prefers a graft instead. Typically the skin for a FTSG is harvested from a local or distant donor site depending on skin tissue match and tissue availability and sutured into place. The site where the FTSG was taken is primarily repaired or allowed to heal via second intent. This study is important because it provides a comparison of cosmetic outcome between interrupted versus running cutaneous sutures. The information provided would help determine if a more efficient suturing technique is non-inferior to a less efficient one, thus saving time for the patient and provider. There is no current standard of practice, with dermatologic surgeons using both interrupted and running sutures, as there is a paucity of literature on this topic as related to full thickness grafts after dermatologic surgery. Running epidermal sutures are more time efficient and thus decrease patient intra-operative time, save on suture material, increase surgeon productivity, and may improve the overall patient operative experience. There have been multiple other split scar studies and studies related to the cosmetic outcomes of various suturing practices. However, there have been none that have looked at simple versus running epidermal stitching of FTSG placement.

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
Triple (Participant, Care Provider, Investigator)

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

  • Inclusion criteria will capture patients
  • 18 years or older
  • have a FTSG reconstruction
  • any body site
  • to close to a primary defect after dermatologic surgery.
  • The authors will exclude patients not undergoing reconstruction with full-thickness skin-graft placement, unable to return for follow-up visits, unable to provide consent (eg. unable to understand spoken/written English, mentally handicapped), and patients under 18 years of age. Male and female patients are eligible. Planned enrollment based on a priori sample size calculation is 52 patients.

排除标准

  • Not undergoing reconstruction with full-thickness skin-graft placement
  • FTSG not large enough to accommodate at least 3 interrupted sutures on one half side
  • Pregnancy or lactation
  • Under 18 years of age
  • Unable/unwilling to return for follow-up visits
  • Unable to provide consent (eg. unable to understand spoken/written English, mentally handicapped)

结局指标

主要结局

The Patient and Observer Scar Assessment Scale (POSAS)

时间窗: POSAS 2.0 observer total score at 3 months post-surgery, calculated as the average of two observers' total scores.

Total observer score of the Patient and Observer Scar Assessment Scale (POSAS) 2.0 The patient score combines scar pain, itch, color, stiffness, thickness, and irregularity (1-10). The observer scale comprises of the items vascularity, pigmentation, thickness, relief, pliability, and surface area. All items of the patient and observer score combined will form a total POSAS score (the highest score represents the worst scar imaginable). It also consists of an overall opinion of the scar

次要结局

  • Patient overall opinion(through study completion, an average of 1 year)
  • Complications(through study completion, an average of 1 year)
  • Clinician overall opinion(through study completion, an average of 1 year)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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