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临床试验/NCT06287866
NCT06287866已完成不适用

Pinch Grafting Versus Second Intention Wound Healing for Mohs Micrographic Surgery Defects on the Scalp

University of California, Davis3 个研究点 分布在 1 个国家目标入组 5 人开始时间: 2024年4月2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
5
试验地点
3
主要终点
Time to re-epithelialization

研究概览

简要总结

Oftentimes, following surgery on the scalp, wounds are left to heal by themselves. This is called "second intention." Open wounds left to heal on the scalp often take 8 weeks or more to completely heal. The investigators are investigating how second intention closure compares to another established reconstruction technique, called "pinch graft." In the pinch graft technique, a dermatological surgeon numbs and then shaves off a thin piece of skin (usually from the groin area) and places it in the wound bed it (also known as "grafting"), to encourage growth of new healthy skin. This study will compare time-to-healing in the second intention method versus the pinch graft method.

详细描述

Pinch graft methodology was first developed in 1976 as a treatment to accelerate healing of lower leg ulcerations, particularly venous or gravitational ulcerations (1, 2). It was later adapted as a tool to hasten healing in surgical wounds, such as surgical closure of diabetic foot wounds (3). It has also been used in the healing of patients with wounds related to dystrophic epidermolysis bullosa (4). More recently, pinch grafts have been investigated as a reconstruction option for Mohs micrographic surgery defects (5). In this study, patients with below the knee Mohs surgical defects were randomized to receive either PG reconstruction or SIH reconstruction. Patients with PG reconstruction healed 20 days sooner (i.e., faster time to reepithelialization) than those who underwent SIH. Complication rates, including infection and reported pain, were also lower in the PG cohort compared to the SIH cohort. SIH is often recommended as a reconstruction technique for surgical wounds without adjacent skin laxity to support primary closure, such as the anterior lower extremity and scalp. There is no study to date examining the use of pinch grafts in scalp wounds. In our study, the investigators explore whether PG is a viable and useful reconstruction method for wounds on the scalp that otherwise would be left to close via SIH. Specifically, in our study, the investigators examine the comparative time to healing and complication rates between PG and SIH in Mohs surgical defects of the scalp.

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

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

入选标准

  • 18 years of age or older
  • Able to give informed consent themselves
  • Patient scheduled for cutaneous surgical procedure on the scalp with predicted second intention closure
  • Willing to return for follow up visit
  • Active user of MyChart
  • Willing to send weekly messages until wound is healed

排除标准

  • Incarceration
  • Under 18 years of age
  • Pregnant women
  • Unable to understand written and oral English
  • Scalp wounds with planned primary repair reconstruction
  • Surgical defects with bone exposure
  • No MyChart access or use

研究组 & 干预措施

Pinch Grafting

Experimental

干预措施: Pinch Graft (Procedure)

Second Intention Wound Healing

No Intervention

结局指标

主要结局

Time to re-epithelialization

时间窗: 1-8 weeks

Participants will submit weekly photos to blinded reviewers to assess for re-epithelization.

次要结局

  • Observer Scar Assessment as measured by Patient Observer Scar Assessment Score (POSAS)(3 months)
  • Patient Scar Assessment as measured by Patient Observer Scar Assessment Score (POSAS)(3 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (3)

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