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CTRI Number  CTRI/2025/02/080791 [Registered on: 18/02/2025] Trial Registered Prospectively
Last Modified On: 16/02/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Medical Device 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Compare standard dressing with iNPWT for recudution of post operative complications 
Scientific Title of Study   Effectiveness of incisional negative pressure wound therapy to reduce serous drainage following modified radical mastectomy in breast cancer patients: A randomised 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 Sanket Kevadiya 
Designation  Junior Resident 
Affiliation  AIIMS Jodhpur 
Address  Department of General Surgery, AIIMS Jodhpur, Basni Phase-2, Jodhpur, Rajasthan-342005.

Jodhpur
RAJASTHAN
342005
India 
Phone  7801837837  
Fax    
Email  sanketkevadiya91@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Satya Prakash Meena 
Designation  Additional Professor 
Affiliation  AIIMS Jodhpur 
Address  Department of General Surgery, AIIMS Jodhpur, Basni Phase-2, Jodhpur, Rajasthan-342005.


RAJASTHAN
342005
India 
Phone  8010861072  
Fax    
Email  drsatyaprakash04@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Sanket Kevadiya 
Designation  Junior Resident 
Affiliation  AIIMS Jodhpur 
Address  Department of General Surgery, AIIMS Jodhpur, Basni Phase-2, Jodhpur, Rajasthan-342005.


RAJASTHAN
342005
India 
Phone  7801837837  
Fax    
Email  sanketkevadiya91@gmail.com  
 
Source of Monetary or Material Support  
Department of General Surgery & Department of Surgical Oncology AIIMS Jodhpur 
 
Primary Sponsor  
Name  AIIMS Jodhpur 
Address  AIIMS Jodhpur, Basni Phase-2, Jodhpur, 342005. 
Type of Sponsor  Research institution 
 
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 Sanket Kevadiya  AIIMS Jodhpur  Department of General Surgery and Department of Surgical Oncology, 5th Floor B Block, OPD Building, AIIMS Jodhpur, Basni Phase-2, Jodhpur
Jodhpur
RAJASTHAN 		 7801837837

sanketkevadiya91@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
InstitutionalEthicsCommittee(Clinical Trials)AllIndiaInstituteofMedicalSceinces   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: C501||Malignant neoplasm of central portion of breast,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Conventional Dressings  Simple foam dressing will be applied in control group. 
Intervention  Negative Pressure Wound Therapy  Closed or incisional negative pressure wound therapy (NPWT) over suture line is a new advancement to reduce postoperative seroma or SSI. It improves lymphatic drainage and reduces lateral tension. Consequently, NPWT may enhance wound healing and limit problems at the surgery site. For the patients with a variety of wound types and surgeries like colorectal cancer surgery, abdominoplasty etc., a negative pressure wound therapy (NPWT) has been widely used. In order to encourage healing, negative pressure wound therapy (NPWT) applies uniformly negative pressure to the wounds surface. The system is made up of a fluid collection system, a sponge, and a semi occlusive barrier. Four primary modes of action—macro deformation of the tissues, drainage of extracellular inflammatory fluids, wound environment stability, and microdeformation—account for its efficacy 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  All female patients with the diagnosis of breast cancer planned for Modified Radical Mastectomy (MRM) in the Department of General Surgery and Department of Surgical Oncology at All India Institute of Medical Sciences, Jodhpur
 
 
ExclusionCriteria 
Details  Patients planned for breast reconstructive surgery
Patients on Anticoagulants (Acitrom, Warfarin, Dabigatran)
Patients on chemotherapy for non-breast malignancy
Patients with diagnosis of unstable medical diseases (cardiac diseases, liver diseases, kidney diseases)
 
 
Method of Generating Random Sequence   Permuted block randomization, fixed 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Reduction in serous discharge after MRM.  POD1,2,3,7,10 
 
Secondary Outcome  
Outcome  TimePoints 
Reduction in flap necrosis, wound infection, wound dehicence.  4 weeks, 8 weeks 
 
Target Sample Size   Total Sample Size="98"
Sample Size from India="98" 
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   Phase 1 
Date of First Enrollment (India)   28/02/2025 
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="5"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
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 - YES
  1. What data in particular will be shared?
    Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response - Informed Consent Form

  3. Who will be able to view these files?
    Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [sanket kevadiya].

  6. For how long will this data be available start date provided 17-12-2024 and end date provided 17-12-2029?
    Response - Beginning 9 months and ending 36 months following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary   This study is designed to compare effectiveness of incisional negative pressure wound therapy to reduce postoperative seroma in the patients undergoing modified radical mastectomy for breast cancer. If statistically significant results are found, then application of incisional negative pressure wound therapy might be used as standard procedure to reduce postoperative complications of modified radical mastectomy. 
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