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临床试验/CTRI/2026/01/101827
CTRI/2026/01/101827招募中不适用

Suturing Versus Adhesive Strips for Skin Biopsy Site Closure: A Randomized Controlled Trial

Dr Anup Uchil B1 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2026年2月2日最近更新:

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
90
试验地点
1
主要终点
Wound appearance, Patient satisfaction,Wound complication

研究概览

简要总结

Background and Justification

  • Rationale: Skin biopsy sites are traditionally closed using sutures, which are reliable but time-intensive and can cause discomfort and scarring. Adhesive strips offer a less invasive, faster, and potentially more patient-friendly alternative.
  • Gap in Knowledge: Limited studies exist in the Indian context evaluating the efficacy and safety of adhesive strips for skin biopsy closures. This research aims to fill that gap and provide evidence for their clinical utility.

Objectives

  • Primary objective:

  • To compare the cosmetic appearance of healed wounds between sutured closures and adhesive strip closures.

  • To evaluate patient satisfaction with the closure method in terms of pain and cosmetic appearance.

  • To assess the incidence of wound complications, including dehiscence, infection, and hematoma, in both groups.

  • Secondary objectives

  • To compare the time required for wound closure using sutures versus adhesive strips.


Methods

  • Study Design: Randomized Controlled Trial.
  • Setting: Institute of DVL, RGGGH & MMC, Chennai.
  • Population: Patients requiring incisional biopsies; exclusions include patients below 18yrs age, pregnancy/lactation, patients with connective tissue disease, patients with venous insufficiency disorders who need skin biopsy over lower limb, patients with scleroderma, bleeding diathesis, documented uncontrolled diabetes mellitus.
  • Sample Size: 90 participants (45 per group), calculated with an 80% power and 5% alpha level.
  • Procedure: Patients randomized into adhesive strip or suture groups. Biopsies performed under local anesthesia with routine aseptic precautions. Closure methods recorded for wound appearance, patient satisfaction, wound complications, operative time and followed up at 1- & 2-weeks post-procedure.

Expected Benefits

  • Clinical Impact: Determine whether adhesive strips improve wound appearance, patient comfort and satisfaction and can reduce procedure time
  • Practical Application: Provide cost-effective and less invasive options for skin biopsy closure, enhancing patient-centered care.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
None

入排标准

年龄范围
18.00 Year(s) 至 65.00 Year(s)(—)
性别
All

入选标准

  • 1.Outpatients requiring incisional skin biopsy for diagnosis 2.Patients giving consent for the study.

排除标准

  • 1.Patients who are pregnant/lactating 2.Patients with Connective Tissue Disease 3.Patients with venous insufficiency disorders who need skin biopsy over lower limb 4.Patients with scleroderma 5.Bleeding diathesis 6.Documented Uncontrolled Diabetes Mellitus.

结局指标

主要结局

Wound appearance, Patient satisfaction,Wound complication

时间窗: 1- & 2- weeks

次要结局

  • Time required for wound closure((Baseline)Time for wound closure is measured from the start to completion of suturing or adhesive strip application(measured in minutes/seconds))

研究者

发起方
Dr Anup Uchil B
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Dr Anup Uchil B

Rajiv Gandhi Government General Hospital And Madras Medical College

研究点 (1)

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