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CTRI Number  CTRI/2026/02/103961 [Registered on: 16/02/2026] Trial Registered Prospectively
Last Modified On: 15/02/2026
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Study comparing two wound closure methods after breast cancer surgery to reduce fluid collection and improve healing. 
Scientific Title of Study   A comparative study of flap fixation with suture quilting vs without quilting in flap closure of the breast cancer patient undergoing modified radical mastectomy A single center Randomized control 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  Chathurvedh Guduri 
Designation  Post Graduate Junior Resident 
Affiliation  All India Institute Of Medical Sciences, Raipur. 
Address  Department of General Surgery, All India Institute Of Medical Sciences, Raipur ,New Administrative Building , B block ,Gate number 4 ,Tatibandh ,Raipur ,Chattisgarh,492099 India

Raipur
CHHATTISGARH
492099
India 
Phone  9121829764  
Fax    
Email  chathurguduri4@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  DrRadhakrishna Ramchandani 
Designation  Associate Professor ,Department Of General Surgery  
Affiliation  All India Institute Of Medical Sciences, Raipur 
Address  Department of General Surgery, All India Institute Of Medical Sciences, Raipur ,New Administrative Building , B block ,Gate number 4 ,Tatibandh ,Raipur ,Chattisgarh,492099 India.

Raipur
CHHATTISGARH
492099
India 
Phone  9424204224  
Fax    
Email  drrramchandani@gmail.com  
 
Details of Contact Person
Public Query  
Name  DrRadhakrishna ramchandani 
Designation  Associate Professor ,Department Of General Surgery  
Affiliation  All India Institute Of Medical Sciences, Raipur 
Address  Department of General Surgery, All India Institute Of Medical Sciences, Raipur ,New Administrative Building , B block ,Gate number 4 ,Tatibandh ,Raipur ,Chattisgarh,492099 India.

Raipur
CHHATTISGARH
492099
India 
Phone  9424204224  
Fax    
Email  drrramchandani@gmail.com  
 
Source of Monetary or Material Support  
All India Institute of Medical Sciences ,Raipur 
 
Primary Sponsor  
Name  All India Institute of Medical Sciences Raipur 
Address  Department of General Surgery, All India Institute Of Medical Sciences, Raipur ,New Administrative Building , B block ,Gate number 4 ,Tatibandh ,Raipur ,Chattisgarh,492099 India. 
Type of Sponsor  Research institution and hospital 
 
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 chathurvedh guduri  All India Institute Of Medical Sciences, Raipur   Department of General Surgery, All India Institute Of Medical Sciences, Raipur ,New Administrative Building , B block ,Gate number 4 ,Tatibandh ,Raipur ,Chattisgarh,492099 India.
Raipur
CHHATTISGARH 		 9121829764

chathurguduri4@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institute Ethics Committee, All India Institute Of Medical Sciences ,Raipur.  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 
Intervention  Flap closure by Quilting sutures.  Taking sutures with the flap and underlying muscle in modified radical mastectomy. 
Comparator Agent  Flap closure without quilting sutures.   No suture is taken between flap and underlying muscle in modified radical mastectomy. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  80.00 Year(s)
Gender  Female 
Details  all female carcinoma breast patients who will undergo modified radical mastectomy in Aiims Raipur 
 
ExclusionCriteria 
Details  Inflammatory carcinoma breast
Age less than 18 years
Tension free closure not possible
Previously operated case of ipsilateral breast cancer. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
To find out the amount of drain output with suture quilting or without quilting in flap closure in patients of breast cancer undergoing modified radical mastectomy.   28 Days  
 
Secondary Outcome  
Outcome  TimePoints 
To compare post operative pain,wound complications,duration of hospital stay and incidence of seroma formation in patients undergoing modified radical mastectomy for breast cancer with suture quilting vs without quilting  on day 7 and weekly until day 28 
 
Target Sample Size   Total Sample Size="56"
Sample Size from India="56" 
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 3 
Date of First Enrollment (India)   01/03/2026 
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)   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 - YES
  1. What data in particular will be shared?
    Response - All of the individual participant data collected during the trial, after de-identification.

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

  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 [drrramchandani@gmail.com].

  6. For how long will this data be available start date provided 01-02-2027 and end date provided 01-02-2030?
    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 thesis Compares two surgical techniques Flap fixation with suture Quilting versus without quilting for Closing the Surgical Site in Breast Cancer patients undergoing modified Radical Mastectomy .The Study aims to determine whether quilting sutures Reduce Post-operative drain output, seroma formation and related complication Conducted as a Single-Center Randomized controlled trial at Aiims Raipur, the study includes 56 female patients , divided into two groups key outcomes Measured are total drain output post operative pain, hospital stay and wound Complications.
The results of this study are Expected to guide surgeons in selecting an optimal closure Method to improve patient recovery and reduce health care burden, Especially in Resource limited settings.
 
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