| CTRI Number |
CTRI/2025/04/084152 [Registered on: 04/04/2025] Trial Registered Prospectively |
| Last Modified On: |
02/04/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A randomized controlled trial comparing the appearance and wound complications of clean surgical wounds in children when closed with Steri-Strips versus subcuticular sutures |
|
Scientific Title of Study
|
A Prospective Randomized Controlled Trial Comparing Cosmesis And Wound Complications Of Pediatric Clean Surgical Wounds Closed With Steri-Strips Versus Subcuticular Suturing |
| 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. Rohaan Rajesh Kamat |
| Designation |
Junior Resident, General Surgery |
| Affiliation |
Bharati Hospital And Research Centre, Bharati Vidyapeeth (Deemed to be University), Pune |
| Address |
Department of General Surgery, 8th Floor,
Bharati Hospital And Research Center,
Bharati Vidyapeeth (Deemed To Be University),
Dhankawadi, Pune,
Maharashtra - 411043
Pune
MAHARASHTRA
411043
India |
| Phone |
8861644200 |
| Fax |
|
| Email |
rohaankamat@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Viraj Chandrashekhar Shinde |
| Designation |
Professor |
| Affiliation |
Bharati Hospital And Research Center, Bharati Vidyapeeth (Deemed to be University), Pune |
| Address |
Department of General Surgery, 8th Floor,
Bharati Hospital And Research Center,
Bharati Vidyapeeth (Deemed To Be University),
Dhankawadi, Pune,
Maharashtra - 411043
Pune
MAHARASHTRA
411043
India |
| Phone |
9175343536 |
| Fax |
|
| Email |
drviraj.shinde@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr. Rohaan Rajesh Kamat |
| Designation |
Junior Resident, General Surgery |
| Affiliation |
Bharati Hospital And Research Centre, Bharati Vidyapeeth (Deemed to be University), Pune |
| Address |
Department of General Surgery, 8th Floor,
Bharati Hospital And Research Center,
Bharati Vidyapeeth (Deemed To Be University),
Dhankawadi, Pune,
Maharashtra - 411043
Pune
MAHARASHTRA
411043
India |
| Phone |
8861644200 |
| Fax |
|
| Email |
rohaankamat@gmail.com |
|
|
Source of Monetary or Material Support
|
| Bharati Hospital And Research Center,
Bharati Vidyapeeth (Deemed To Be University),
Dhankawadi, Pune,
Maharashtra - 411043,
India |
|
|
Primary Sponsor
|
| Name |
Bharati Hospital And Research Centre Bharati Vidyapeeth Deemed to be University Pune |
| Address |
Bharati Hospital And Research Center,
Bharati Vidyapeeth (Deemed To Be University),
Dhankawadi, Pune,
Maharashtra - 411043,
India |
| Type of Sponsor |
Private medical college |
|
|
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 Rohaan Rajesh Kamat |
Bharati Hospital And Research Centre, Bharati Vidyapeeth (Deemed to be University), Pune |
Pediatric Surgery OPD,
Ground Floor, Super Speciality Wing,
Bharati Hospital And Research Center,
Bharati Vidyapeeth (Deemed to be University),
Dhankawadi, Pune,
Maharashtra - 411043.
Pune
MAHARASHTRA |
8861644200
rohaankamat@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| BHARATI VIDHYAPEETH(DEEMED TO BE UNIVERSITY), MEDICAL COLLEGE, INSTITUTIONAL ETHICS COMMITTEE |
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 |
Steri-Strips |
Closure of Pediatric Clean Surgical Wounds with Steri-Strips |
| Comparator Agent |
Subcuticular Suturing |
Closure of Pediatric Clean Surgical Wounds by Subcuticular Suturing |
|
|
Inclusion Criteria
|
| Age From |
0.00 Day(s) |
| Age To |
18.00 Year(s) |
| Gender |
Both |
| Details |
Patients undergoing clean surgeries |
|
| ExclusionCriteria |
| Details |
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). |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| 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
|
| Outcome |
TimePoints |
| To demonstrate significant cost reduction by using Steri-Strips instead of subcuticular sutures for closure of pediatric clean surgical wounds |
Post operative day 5
2 weeks post surgery
2 months post surgery |
|
|
Target Sample Size
|
Total Sample Size="46"
Sample Size from India="46"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
14/04/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
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
|
The
study will be conducted in a Tertiary Care Centre in Pune. Patients fulfilling
the inclusion criteria and consenting for the study will be selected. They will
be blinded and divided into 2 groups (Steri-Strips versus Subcuticular Suturing).
Their personal data and clinical details will be noted. The surgical wound
would be assessed subjectively by the patient/ parent/ guardian and objectively
by the Plastic Surgeon using the POSAS 2.0 scale at regular intervals (POD-5, at 2 weeks
and at 2 months post surgery). |