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临床试验/NCT07844681
NCT07844681尚未招募不适用

A Prospective Randomized Study of Surgical Site Infection After Linear Repair With or Without Cyanoacrylate Skin Adhesive Following Mohs Micrographic Surgery and Wide Local Excision

University of Minnesota3 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2026年10月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
尚未招募
入组人数
300
试验地点
3
主要终点
Surgical Site Infection Within 30 Days After Linear Repair

研究概览

简要总结

This study will compare surgical site infection after linear repair with or without cyanoacrylate skin adhesive following Mohs micrographic surgery or wide local excision.

Adult participants undergoing Mohs micrographic surgery or wide local excision for skin cancer with a surgical defect suitable for linear repair will be stratified by suture type and randomized to standardized running epidermal suture closure with or without cyanoacrylate skin adhesive.

The primary outcome is surgical site infection within 30 days after surgery. Secondary outcomes include scar quality, treatment satisfaction, wound care burden, wound healing characteristics, antibiotic use, culture results, health care utilization related to wound concerns, and adverse events.

详细描述

Surgical site infection is an uncommon but clinically important complication after dermatologic surgery. Linear repairs are frequently performed after Mohs micrographic surgery and wide local excision, and closure technique may affect infection risk, wound healing, scar quality, and patient experience.

This is a prospective, randomized, stratified parallel group clinical study evaluating postoperative outcomes after standardized running epidermal suture closure with or without cyanoacrylate skin adhesive. Adult patients undergoing Mohs micrographic surgery or wide local excision for skin cancer will be screened on the day of surgery. Participants will be eligible if the surgical defect is suitable for linear repair using standardized running epidermal sutures.

Participants will be stratified by suture type. In the absorbable suture stratum, participants will be randomized using a 2×2 factorial design to fast gut or Vicryl Rapide suture material and to adhesive use or no adhesive. In the non-absorbable suture stratum, participants will receive Prolene and will be randomized to closure with or without cyanoacrylate skin adhesive.

All participants will undergo Mohs micrographic surgery or wide local excision as part of standard clinical care. Research procedures include randomization of closure approach, standardized wound photography, follow-up assessments at approximately 2 weeks and 3 months, documentation of infection or suspected infection, wound healing assessment, adverse event assessment, and patient-reported outcome measures.

The primary outcome is surgical site infection within 30 days following linear repair. Secondary outcomes include antibiotic use, wound healing metrics, patient-reported treatment satisfaction and wound care burden, scar quality using the Patient and Observer Scar Assessment Scale 3.0 Linear Scar Version, culture results and treatment descriptions when infection is suspected, health care utilization related to wound concerns, and adverse events.

研究设计

研究类型
干预性
分配方式
随机
干预模型
平行分组
主要目的
预防
盲法
单盲 (受试者)

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

  • Age 18 years or older
  • Undergoing Mohs micrographic surgery or wide local excision for skin cancer
  • Surgical defect suitable for linear repair
  • Surgical defect suitable for linear repair using standardized running epidermal sutures
  • Ability to provide informed consent
  • Ability to read at a 5th grade level or above, needed for survey administration

排除标准

  • Requirement for flap, graft, geometric repair, or healing by second intention
  • Active infection or severe contamination at the surgical site prior to closure
  • Known allergy or hypersensitivity to cyanoacrylate adhesive, fast gut, Vicryl Rapide, or Prolene
  • Recurrent tumor at the surgical site
  • Prior radiation therapy to the surgical site
  • Current use of systemic antibiotics for an unrelated medical condition at the time of surgery
  • Concurrent participation in another interventional research study that could confound wound healing or infection outcomes
  • Inability to comply with study procedures or follow-up visits
  • Any condition that, in the judgment of the investigator, would interfere with safe participation or interpretation of study outcomes
  • Children
  • Fetuses
  • Neonates
  • Prisoners
  • Adults lacking capacity to consent or adults with diminished or fluctuating capacity to consent
  • Non-English speakers
  • Individuals unable to read
  • Employees of the researcher

研究组 & 干预措施

Fast Gut Sutures With Adhesive

Experimental

Participants in the absorbable suture stratum will receive standardized running epidermal closure using fast gut sutures followed by cyanoacrylate skin adhesive.

干预措施: Cyanoacrylate Skin Adhesive (Device)

Fast Gut Sutures With Adhesive

Experimental

Participants in the absorbable suture stratum will receive standardized running epidermal closure using fast gut sutures followed by cyanoacrylate skin adhesive.

干预措施: Fast Gut Running Epidermal Suture Closure (Procedure)

Fast Gut Sutures Without Adhesive

Active Comparator

Participants in the absorbable suture stratum will receive standardized running epidermal closure using fast gut sutures without cyanoacrylate skin adhesive.

干预措施: Fast Gut Running Epidermal Suture Closure (Procedure)

Vicryl Rapide Sutures With Adhesive

Experimental

Participants in the absorbable suture stratum will receive standardized running epidermal closure using Vicryl Rapide sutures followed by cyanoacrylate skin adhesive.

干预措施: Cyanoacrylate Skin Adhesive (Device)

Vicryl Rapide Sutures With Adhesive

Experimental

Participants in the absorbable suture stratum will receive standardized running epidermal closure using Vicryl Rapide sutures followed by cyanoacrylate skin adhesive.

干预措施: Vicryl Rapide Running Epidermal Suture Closure (Procedure)

Vicryl Rapide Sutures Without Adhesive

Active Comparator

Participants in the absorbable suture stratum will receive standardized running epidermal closure using Vicryl Rapide sutures without cyanoacrylate skin adhesive.

干预措施: Vicryl Rapide Running Epidermal Suture Closure (Procedure)

Prolene Sutures With Adhesive

Experimental

Participants in the non-absorbable suture stratum will receive standardized running epidermal closure using Prolene sutures followed by cyanoacrylate skin adhesive.

干预措施: Cyanoacrylate Skin Adhesive (Device)

Prolene Sutures With Adhesive

Experimental

Participants in the non-absorbable suture stratum will receive standardized running epidermal closure using Prolene sutures followed by cyanoacrylate skin adhesive.

干预措施: Prolene Running Epidermal Suture Closure (Procedure)

Prolene Sutures Without Adhesive

Active Comparator

Participants in the non-absorbable suture stratum will receive standardized running epidermal closure using Prolene sutures without cyanoacrylate skin adhesive.

干预措施: Prolene Running Epidermal Suture Closure (Procedure)

结局指标

主要结局

Surgical Site Infection Within 30 Days After Linear Repair

时间窗: Within 30 days after Mohs micrographic surgery or wide local excision

Surgical site infection will be assessed within 30 days following linear repair after Mohs micrographic surgery or wide local excision. Surgical site infection is defined as culture-confirmed infection or strong clinical suspicion of infection when a culture cannot be obtained, including purulent discharge, erythema with edema or warmth, drainage consistent with infection, or cellulitis requiring antibiotic therapy.

次要结局

  • Wound Care Burden(2 weeks after surgery)
  • Systemic Antibiotic Use(Baseline through 30 days after surgery)
  • Wound Healing Complications(7 to 14 days and 30 days after surgery)
  • Treatment Satisfaction(2 weeks and 3 months after surgery)
  • Scar Quality(3 months after surgery)
  • Culture Results and Infection Treatment(Within 30 days after surgery)
  • Health Care Utilization Related to Wound Concerns(Baseline through 3 months after surgery)
  • Adverse Events(Baseline through 3 months after surgery)

研究者

申办方类型
其他
责任方
申办方

研究点 (3)

Loading locations...

标识符

NCT 编号
NCT07844681
其他研究编号
DERM-2026-35119

日期

首次提交
(9天前)
首次发布
(前天)
主要完成日期
(2年后)
研究完成日期
(2年后)
最近核实
(29天前)
最近更新
(前天)

监管与共享

FDA 监管药物
否
FDA 监管器械
是
是否有结果
否

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