A randomized controlled trial comparing the appearance and wound complications of clean surgical wounds in children when closed with Steri-Strips versus subcuticular sutures

Not yet recruiting

• Conditions: Medical and Surgical,

• Registration Number: CTRI/2025/04/084152
• Lead Sponsor: Bharati Hospital And Research Centre Bharati Vidyapeeth Deemed to be University Pune

Brief Summary

Thestudy will be conducted in a Tertiary Care Centre in Pune. Patients fulfillingthe inclusion criteria and consenting for the study will be selected. They willbe blinded and divided into 2 groups (Steri-Strips versus Subcuticular Suturing).Their personal data and clinical details will be noted. The surgical woundwould be assessed subjectively by the patient/ parent/ guardian and objectivelyby the Plastic Surgeon using the POSAS 2.0 scale at regular intervals (POD-5, at 2 weeksand at 2 months post surgery).

Detailed Description

Not available

Study Timeline

• Last Update Posted: 2025-02-04
• Study Start: 2025-04-14

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 46

Inclusion Criteria

Patients undergoing clean surgeries.

Exclusion Criteria

• History of surgery previously at proposed site of surgery.
• Known co-morbidities (Diabetes, Bronchial Asthma, Tuberculosis).
• Patient having severe anemia.
• Patient with bleeding/ clotting disorder.
• Patient having cutaneous infection or dermatitis pre-operatively in close proximity to the proposed surgical site.
• Patient on chemotherapy or steroid treatment for other concomitant condition.
• Surgical wounds deemed unfit for Steri-Strip application by operating surgeon at the time of wound closure (Presence of infection, high tension wounds/ wounds difficult to approximate with fingers, wounds with exudate, wounds over highly mobile areas like joints).

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Comparing cosmesis and wound complications of pediatric clean surgical wounds closed with Steri-Strip versus Subcuticular Sutures	Post operative day 5 | 2 weeks post surgery | 2 months post surgery

Secondary Outcome Measures

Name	Time	Method
To demonstrate significant cost reduction by using Steri-Strips instead of subcuticular sutures for closure of pediatric clean surgical wounds	Post operative day 5

Trial Locations

Locations (1)

Bharati Hospital And Research Centre, Bharati Vidyapeeth (Deemed to be University), Pune; 🇮🇳 Pune, MAHARASHTRA, India

Bharati Hospital And Research Centre, Bharati Vidyapeeth (Deemed to be University), Pune

🇮🇳Pune, MAHARASHTRA, India

Dr Rohaan Rajesh Kamat

Principal investigator

8861644200

rohaankamat@gmail.com