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CTRI Number  CTRI/2024/11/076107 [Registered on: 01/11/2024] Trial Registered Prospectively
Last Modified On: 30/10/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   A RCT comparing triclosan coated suture with non coated suture in closing midline laparotomies to assess decrease in SSI and Wound dehiscence 
Scientific Title of Study   Effectiveness of triclosan coated polydioxanone suture in comparison to non coated polydioxanone suture in closure of midline laparotomies in terms of SSI and wound dehiscence a randomized 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 PRAGYA SINHA 
Designation  Postgraduate 
Affiliation  Rajendra institute of medical sciences 
Address  2nd Floor , Department of General Surgery , RIMS , Bariatu , Ranchi

Ranchi
JHARKHAND
834009
India 
Phone  8405970883  
Fax    
Email  pragyasinha.8@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr. Nishith M Paul Ekka 
Designation  Associate Professor 
Affiliation  Rajendra institute of medical sciences 
Address  Department go General Surgery , RIMS , Bariatu , Ranchi

Ranchi
JHARKHAND
834009
India 
Phone  9431358260  
Fax    
Email  drnmpekka@gmail.com  
 
Details of Contact Person
Public Query  
Name  DR PRAGYA SINHA 
Designation  Postgraduate 
Affiliation  Rajendra institute of medical sciences 
Address  2nd Floor , Department of General Surgery , RIMS , Bariatu , Ranchi

Ranchi
JHARKHAND
834009
India 
Phone  8405970883  
Fax    
Email  pragyasinha.8@gmail.com  
 
Source of Monetary or Material Support  
Rajendra Institute of Medical Sciences , Bariatu , Ranchi , Jharkhand-834009 , India 
 
Primary Sponsor  
Name  Rajendra Institute of medical sciences 
Address  Bariatu , Ranchi , Jharkhand , 834009 
Type of Sponsor  Government medical college 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Pragya Sinha  Rajendra Institute of Medical Sciences  Surgery OT , 2nd floor , Department of General Surgery , Bariatu , RIMS Ranchi
Ranchi
JHARKHAND 		 8405970883

pragyasinha.8@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Rajendra Institute of Medical Sciences  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: O||Medical and Surgical,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Non coated Polydioxanone suture  monofilament synthetic absorbable suture Dose - There is no drug coated in the suture . Length of suture used will be according to the wound length. Route of administration - Topical Frequency - Single 
Intervention  Triclosan coated polydioxanone suture  dose: MP 2360 microgram/meter Route of administration : Topical Frequency - Single  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  Patients undergoing midline laparotomy.
Both elective and emergency cases.
Those who will be treated at RIMS Ranchi between [study duration] 
 
ExclusionCriteria 
Details  Patients who are planned for second look surgery
Patients who are immunocompromised or on immunosuppresants .
Patients undergoing stoma reversal surgery. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   On-site computer system 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
Incidence of Surgical site infection and wound dehiscence  15 days 
 
Secondary Outcome  
Outcome  TimePoints 
risk ratio of SSI in patients with midline laparotomies.  15 days 
To estimate the risk ratio of wound dehiscence in patients with midline laparotomies.  15 days 
To estimate the baseline characteristics of patients with midline laparotomies.  15 days 
 
Target Sample Size   Total Sample Size="154"
Sample Size from India="154" 
Final Enrollment numbers achieved (Total)= "154"
Final Enrollment numbers achieved (India)="154" 
Phase of Trial   Phase 4 
Date of First Enrollment (India)   12/11/2024 
Date of Study Completion (India) 27/02/2025 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
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 - YES
  1. What data in particular will be shared?
    Response - All of the individual participant data collected during the trial, after de-identiļ¬cation.

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form
    Response - Clinical Study Report
    Response -  Analytic Code

  3. Who will be able to view these files?
    Response - Anyone

  4. For what types of analyses will this data be available?
    Response - Any purpose.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [pragyasinha.8@gmail.com].

  6. For how long will this data be available start date provided 01-11-2025 and end date provided 01-11-2030?
    Response - Beginning 3 months and ending 5 years following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - nil
Brief Summary   This study is a randomised  single blind , parallel group , single centre trial assessing the effectiveness of Triclosan coated polydioxanone suture in comparison to non coated polydioxanone suture in Rajendra institute of Medical Sciences , Ranchi , Jharkhand,  India .  The primary outcome will be to determine the incidence of surgical site infection (SSI)  and wound dehiscence at day 15 . The secondary outcomes are to estimate the risk ratio of SSI and Wound dehiscence at day 15 ; and to estimate the baseline characteristics of patients with midline laparotomies. 
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