| CTRI Number |
CTRI/2026/01/101827 [Registered on: 22/01/2026] Trial Registered Prospectively |
| Last Modified On: |
29/06/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A study comparing stitches and adhesive strips for closing skin biopsy wounds |
|
Scientific Title of Study
|
Suturing Versus Adhesive Strips for Skin Biopsy Site Closure: A Randomized Controlled Trial |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Anup Uchil B |
| Designation |
Second year postgraduate |
| Affiliation |
Rajiv Gandhi Government General Hospital And Madras Medical College |
| Address |
INSTITUTE OF DVL
DEPARTMENT OF DERMATOLOGY
OPD number 47,Tower 3,Fourth floor
RGGGH And MMC
Chennai 600003
Chennai
TAMIL NADU
600003
India |
| Phone |
9880884190 |
| Fax |
|
| Email |
uanup1992@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR. V SAMPATH |
| Designation |
Director |
| Affiliation |
Rajiv Gandhi Government General Hospital And Madras Medical College |
| Address |
INSTITUTE OF DVL
DEPARTMENT OF DERMATOLOGY
OPD number 47,Tower 3,Fourth floor
RGGGH And MMC
Chennai 600003
Chennai
TAMIL NADU
600003
India |
| Phone |
|
| Fax |
|
| Email |
sampv11@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Anup Uchil B |
| Designation |
Second year postgraduate |
| Affiliation |
Rajiv Gandhi Government General Hospital And Madras Medical College |
| Address |
INSTITUTE OF DVL
DEPARTMENT OF DERMATOLOGY
OPD number 47,Tower 3,Fourth floor
RGGGH And MMC
Chennai 600003
Chennai
TAMIL NADU
600003
India |
| Phone |
9880884190 |
| Fax |
|
| Email |
uanup1992@gmail.com |
|
|
Source of Monetary or Material Support
|
| INSTITUTE OF DVL
RGGGH And MMC
Chennai 600003 |
|
|
Primary Sponsor
|
| Name |
Dr Anup Uchil B |
| Address |
INSTITUTE OF DVL
RGGGH And MMC
Chennai 600003 |
| Type of Sponsor |
Other [SELF] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Anup Uchil B |
Rajiv Gandhi Government General Hospital |
INSTITUTE OF DVL
DEPARTMENT OF DERMATOLOGY
OPD number 47,Tower 3,Fourth floor
Chennai
TAMIL NADU |
9880884190
uanup1992@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee,Madras Medical College,Chennai 600 003 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Adhesive Strips |
3M Steri-Strips; 3M, Minneapolis, MN
Adhesive strips are removed 1 week after application. |
| Comparator Agent |
Suturing |
Non-absorbable 3-0 polypropylene suture
Sutures are removed 1 week after application. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1.Outpatients requiring incisional skin biopsy for diagnosis
2.Patients giving consent for the study
|
|
| ExclusionCriteria |
| Details |
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 |
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
Pre-numbered or coded identical Containers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Wound appearance, Patient satisfaction,Wound complication |
1- & 2- weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| 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) |
|
|
Target Sample Size
|
Total Sample Size="90"
Sample Size from India="90"
Final Enrollment numbers achieved (Total)= "90"
Final Enrollment numbers achieved (India)="90" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
02/02/2026 |
| Date of Study Completion (India) |
29/06/2026 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
29/06/2026 |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Completed |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Background and JustificationRationale: 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.
ObjectivesPrimary 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.
MethodsStudy 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 |