FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2023/02/049897 [Registered on: 20/02/2023] Trial Registered Prospectively
Last Modified On: 18/02/2023
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   A RANDOMISED CONTROL STUDY COMPARING THE PLACEMENT OF 2 DRAINS, THAT IS, IN AXILLA AND PECTORAL SKIN FLAP VERSUS SINGLE DRAIN IN AXILLA POST MODIFIED RADICAL MASTECTOMY IN PREVENTING POST OPERATIVE SEROMA AND LOCAL COMPLOCATIONS 
Scientific Title of Study   A prospective randomized controlled study to compare the efficacy of combined Axillary and Pectoral drainage versus Sole Axillary drainage in Modified Radical Mastectomy 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  DR SIDDHARTH P DUBHASHI 
Designation  HEAD OF DEPARTMENT  
Affiliation  AIIMS NAGPUR 
Address  DEPARTMENT OF GENERAL SURGERY AIIMS NAGPUR PLOT NO 2, SECTOR 20 SUMTHANA

Nagpur
MAHARASHTRA
441108
India 
Phone  9881624422  
Fax    
Email  spdubhashi@aiimsnagpur.edu.in  
 
Details of Contact Person
Scientific Query
 
Name  DR DEEPALI SHETTY 
Designation  JUNIOR RESIDENT 
Affiliation  AIIMS, NAGPUR 
Address  ROOM 202, 2ND FLOOR DEPARTMENT OF GENERAL SURGREY AIIMS NAGPUR PLOT NO2, SECTOR 20 MIHAN, NAGPUR

Nagpur
MAHARASHTRA
441108
India 
Phone  9008811623  
Fax    
Email  djshetty97@gmail.com  
 
Details of Contact Person
Public Query
 
Name  DR DEEPALI SHETTY 
Designation  JUNIOR RESIDENT 
Affiliation  AIIMS, NAGPUR 
Address  ROOM 202, 2ND FLOOR DEPARTMENT OF GENERAL SURGERY AIIMS NAGPUR PLOT NO2, SECTOR 20 MIHAN, NAGPUR

Nagpur
MAHARASHTRA
441108
India 
Phone  9008811623  
Fax    
Email  djshetty97@gmail.com  
 
Source of Monetary or Material Support  
AIIMS, NAGPUR PLOT NO2, SECTOR 20 MIHAN, SUMTHANA 441108, NAGPUR 
 
Primary Sponsor  
Name  DR DEEPALI SHETTY 
Address  AIIMS NAGPUR MIHAN, SUMTHANA 
Type of Sponsor  Other [SELF] 
 
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 DEEPALI J SHETTY  AIIMS NAGPUR  DEPARTMENT OF GENERAL SURGERY, ROOM 202 AIIMS NAGPUR PLOT NO 2, SECTOR 20 SUMTHANA
Nagpur
MAHARASHTRA 
9008811623

djshetty97@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee, Department of Pharmacology, AIIMS Nagpur  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: C50-C50||Malignant neoplasms of breast,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  COMBINED AXILLARY AND PECTORAL DRAIN  ROMOVAC NO 14 DRAIN PLACED IN AXILLA AND PECTORAL FLAP FREQUENCY NOT APPLICABLE DURATION- PATIENT DEPENDANT 
Intervention  SINGLE AXILLARY DRAIN  SINGLE ROMOVAC SUCTION DRAIN NO 14 PLACED IN AXILLA FREQUENCY NOT APPLICABLE DURATION- PATIENT DEPENDANT 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  90.00 Year(s)
Gender  Female 
Details  Histologically proven Breast cancer patients of Stage 1 and II undergoing Modified Radical Mastectomy
Stage III breast cancer not receiving neo-adjuvant treatment undergoing Modified Radical Mastectomy
 
 
ExclusionCriteria 
Details  Recurrent breast cancer
Patients receiving Neoadjuvant chemotherapy or Radiotherapy
Metastatic breast cancer
 
 
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 
To assess occurrence of post-operative seroma with use of single versus double drainage in modified radical mastectomy, in patients with histologically proven breast cancer not undergoing neoadjuvant therapy  1ST, 3RD, 5TH, 7TH, 9TH DAY POST OPERATIVELY 
 
Secondary Outcome  
Outcome  TimePoints 
Post-operative pain
Occurrence of Flap necrosis
Duration of drain in-situ
Drain output
Length of hospital stay
 
3RD, 6TH, 9TH DAY POST OPERATIVELY 
 
Target Sample Size   Total Sample Size="156"
Sample Size from India="156" 
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 2 
Date of First Enrollment (India)   25/02/2023 
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   NONE YET 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  

Breast cancer has seen a rapid rise in incidence, becoming the leading cause of global cancer incidence in 2020. Choice of treatment is Modified Radical Mastectomy (MRM). Most commonly encountered complication of MRM is formation of seroma, which can be prevented by the use of closed suction drainage system, preferable active suction drainage.

 

This Prospective Randomised controlled study attempts to compare the efficacy and the morbidities associated with use of combined axillary and pectoral drain versus single axillary drainage post modified radical mastectomy.

Objectives: Assessing the incidence of seroma formation, post op wound infection, duration of drain insitu, drain output and length of hospital stay

 

Women with histologically proven breast cancer, stage 1,2 3 not undergoing neoadjuvant therapy undergoing MRM, will be included in the study and will be randomized into 2 groups using envelope method, Group A (single axillary drain) and Group B (combined axillary and pectoral drainage), with 78 patients in each group (total sample size 156)

 

Standardized operative procedure and post-operative course will be followed in all patients in both groups in drain emptying and dressing

Patient will be followed up postoperatively to evaluate drain output, incidence of surgical site infection, flap necrosis, seroma formation (clinically and quantified with ultrasonography), timing of drain removal and total duration of hospital stay.

 

Data will collected and analyzed with SPSS version 28.

 The quantitative data will be reported as mean and standard deviation. Differences between means will be tested with Student’s t-test and the incidence of seroma, flap necrosis and wound infection will be reported as number and percentages and Fisher’s exact test/ Chi square test will be employed.

 

 
Close