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CTRI Number  CTRI/2025/07/089967 [Registered on: 02/07/2025] Trial Registered Prospectively
Last Modified On: 12/10/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Cluster Randomized Trial 
Public Title of Study   Comparison between two suturing techniques for mastectomy wounds: A Randomized Controlled Trial 
Scientific Title of Study   Multiple segmented Purse-string suturing vs Interrupted simple suturing of subcutaneous layer in mastectomy wounds: A Randomized Controlled Trial 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  Other 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Rahul Gowda R 
Designation  Junior Resident 
Affiliation  Kasturba Medical College, Manipal 
Address  Department of General Surgery, 3rd floor, Smt. Sharada Madhav Pai OPD Building Kasturba Hospital, Manipal

Udupi
KARNATAKA
576104
India 
Phone  9900100123  
Fax    
Email  rahul1.kmcmpl2024@learner.manipal.edu  
 
Details of Contact Person
Scientific Query  
Name  Dr Stanley Mathew 
Designation  Professor 
Affiliation  Kasturba Medical College, Manipal 
Address  Department of General Surgery, 3rd floor, Smt. Sharada Madhav Pai OPD Building Kasturba Hospital, Manipal

Udupi
KARNATAKA
576104
India 
Phone  9844409900  
Fax    
Email  stanley.mathew@manipal.edu  
 
Details of Contact Person
Public Query  
Name  Dr Badareesh L 
Designation  Professor 
Affiliation  Kasturba Medical College, Manipal 
Address  Department of General Surgery, 3rd floor, Smt. Sharada Madhav Pai OPD Building Kasturba Hospital, Manipal 576104

Udupi
KARNATAKA
576104
India 
Phone  8861038876  
Fax    
Email  badareesh.l@manipal.edu  
 
Source of Monetary or Material Support  
Department of General Surgery, Kasturba Medical College, Manipal 576014, Udupi District, Karnataka State, India 
 
Primary Sponsor  
Name  Dean DrAnil Bhat K 
Address  Kasturba Medical College, First Floor, Administrative Block, Madhav Nagar, Manipal 576104, Udupi District, Karnataka State, 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 Stanley Mathew  Department of General Surgery  3rd Floor, Smt.Sharadha Madhav Pai OPD Building, Kasturba Hospital, Manipal
Udupi
KARNATAKA 		 9844409900

stanley.mathew@manipal.edu 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Kasturba Medical College and Kasturba Hospital Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: C508||Malignant neoplasm of overlappingsites of breast, (2) ICD-10 Condition: O||Medical and Surgical,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Interrupted simple suturing technique   After mastectomy is completed, the edges of the superior and inferior flaps are marked with 1.0 cm intervals. Suturing of the mastectomy wound is done using the technique of multiple interrupted mattress sutures with polyglactin 910 absorbable 2-0 material taken at the 1.0 cm marks to ensure complete wound closure 
Intervention  Multiple segmented purse string suturing technique  After mastectomy is completed, the edges of the superior and inferior flaps are marked with 1.0 cm intervals. Suturing of the mastectomy wound is done using the technique of multiple purse string sutures with polyglactin 910 absorbable 2-0 material taken at the 1.0 cm marks to ensure complete wound closure 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  99.00 Year(s)
Gender  Female 
Details  Female patients undergoing Mastectomy 
 
ExclusionCriteria 
Details  Patients with preexisting skin infections at surgical site
Immunocompromised patients (HIV, Uncontrolled diabetes mellitus, Long term steroid use)
Prior chest radiation
Collagen vascular disorders 
 
Method of Generating Random Sequence   Permuted block randomization, fixed 
Method of Concealment   Other 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To compare wound dimensions between the two suturing techniques  40 days 
 
Secondary Outcome  
Outcome  TimePoints 
The extent of flap necrosis  40 days 
Delayed Wound healing  40 days 
Incidence of Wound infection  40 days 
Day of suture removal  30 days 
 
Target Sample Size   Total Sample Size="80"
Sample Size from India="80" 
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 4 
Date of First Enrollment (India)   14/07/2025 
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="6"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Yet Recruiting 
Recruitment Status of Trial (India)  Open to Recruitment 
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 (Others) -  Researchers and journal editors

  4. For what types of analyses will this data be available?
    Response - For individual participant data meta-analysis.

  5. By what mechanism will data be made available?
    Response (Others) -  Data will be shared if written request is made

  6. For how long will this data be available start date provided 01-02-2027 and end date provided 01-02-2032?
    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  
After obtaining approval from the IEC, informed consent will be obtained from the participants posted for mastectomy. Patient will be randomly choosing one of the six surgical units and undergo the standard of care suturing technique of that particular unit. Three surgical units form Cluster ISS - interrupted simple subcutaneous suturing and another 3 surgical units form Cluster PSS  - Segmented purse string suturing. After mastectomy is completed and just before the closure, the dimensions of the wound are assessed and is closed using segmented purse string technique or  interrupted simple subcutaneous suturing based on the cluster group. The wound dimensions after closure is then measured. Patients of both clusters are reassessed for wound infection on the day of first post operative wound examination and any subsequent follow-up days up to 30+10 days or commencement of adjuvant therapy, to look for any infection, flap necrosis or delay in wound healing. The results of the two groups will be compared to establish non inferiority.
 
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