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CTRI Number  CTRI/2021/12/038884 [Registered on: 23/12/2021] Trial Registered Prospectively
Last Modified On: 02/02/2023
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Medical Device 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   A study comparing two different Non-Adherent Wound Dressing in Obstetric and Gynecological surgeries 
Scientific Title of Study   A single blind, single centre, randomized, comparative study to assess the safety and effectiveness of Trushield NXT Non-Adherent Wound Dressing versus Tegaderm HPPad Film Dressing with Non-Adherent Pad in post-operative wound management of Obstetric and Gynecological surgeries 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Prema DCunha 
Designation  Professor 
Affiliation  Father Muller Medical College 
Address  Department of OBG Father Muller Medical College, Father Muller Road, Kankanady

Dakshina Kannada
KARNATAKA
575002
India 
Phone  9845342488  
Fax    
Email  prema_dcunha@yahoo.com  
 
Details of Contact Person
Scientific Query  
Name  Prema DCunha 
Designation  Professor 
Affiliation  Father Muller Medical College 
Address  Department of OBG Father Muller Medical College, Father Muller Road, Kankanady

Dakshina Kannada
KARNATAKA
575002
India 
Phone  9845342488  
Fax    
Email  prema_dcunha@yahoo.com  
 
Details of Contact Person
Public Query  
Name  Prema DCunha 
Designation  Professor 
Affiliation  Father Muller Medical College 
Address  Department of OBG Father Muller Medical College, Father Muller Road, Kankanady

Dakshina Kannada
KARNATAKA
575002
India 
Phone  9845342488  
Fax    
Email  prema_dcunha@yahoo.com  
 
Source of Monetary or Material Support  
Father Muller Medical College 
 
Primary Sponsor  
Name  Father Muller Medical College 
Address  Father Muller Road, Kankanady, Mangalore – 575 002, Karnataka, India  
Type of Sponsor  Private 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 Prema DCunha  Father Muller Medical College  Room no 19, Department of OBG, Father Muller Road, Kankanady
Dakshina Kannada
KARNATAKA 		 9845342488

prema_dcunha@yahoo.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Father Muller Institutional Ethics Committee, Father Muller Research Center, Mangalore  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: O82||Encounter for cesarean delivery without indication,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Tegaderm HP Pad Film Dressing with Non-Adherent Pad   Non-adherent Wound dressing which is applied on surgical wounds for upto 3 days after surgery  
Intervention  Trushield NXT Non-Adherent Wound Dressing  Non-adherent Wound dressing which is applied on surgical wounds for upto 3 days after surgery 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Female 
Details  1. Women of age 18 – 65 years
2. Subject undergoing uncomplicated open obstetric/gynecological surgery in the opinion of the investigator
3. Subject with Hb ≥ 9gm/dl
4. Subject ready to give written consent for the study 
 
ExclusionCriteria 
Details  1. Subject with condition/comorbidity that could compromise wound healing, including eczema, peripheral vascular disease, receiving immunosuppressive, high dose corticosteroid medications, corticosteroid abuse, and having uncontrolled diabetes
2. Subject with a systemic infection not controlled by suitable antibiotic treatment
3. Subject with an active neoplastic condition, treated by radiotherapy, chemotherapy, hormone therapy or immunosuppressant agents
4. Subject participating in another clinical study less than 30 days before participation in this study
5. Investigator’s discretion 
 
Method of Generating Random Sequence   Permuted block randomization, variable 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
To assess effectiveness of Trushield NXT Non adherent wound dressing Versus Tegaderm HP+Pad Film Dressing with Non-Adherent Pad in post-operative wound management of obstetric and gynecological surgeries  Day 0, 3, 10 and 35 
 
Secondary Outcome  
Outcome  TimePoints 
1. To evaluate post-operative wound complications
2. To evaluate scar cosmesis
3. To evaluate subject and surgeon satisfaction of the dressing
4. To evaluate wound pain and pain during dressing removal
5. To evaluate material problems and other adverse events 		 Day 0, 3, 10 and 35 
 
Target Sample Size   Total Sample Size="102"
Sample Size from India="102" 
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" 
Phase of Trial   Phase 4 
Date of First Enrollment (India)   27/12/2021 
Date of Study Completion (India) Date Missing 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="3"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   NIL 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary   This study aims to compare the efficacy and safety of two non-adherent surgical wound dressings; Trushield NXT Non adherent wound dressing developed by Healthium Medtech Limited in comparison with Tegaderm HP+Pad Film Dressing with Non-Adherent Pad developed by 3M. Both the dressings are approved for usage in India.  
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