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CTRI Number  CTRI/2024/05/066983 [Registered on: 08/05/2024] Trial Registered Prospectively
Last Modified On: 29/05/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Does stitching down of flap tissue affect the fluid build up under flap after surgery for breast cancer 
Scientific Title of Study   To study the effect of flap fixation on seroma formation in patients undergoing modified radical mastectomy a randomized 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 Amjad Sayeed 
Designation  Junior Resident 
Affiliation  PGIMER, Chandigarh 
Address  Department of General Surgery, 5th Floor, Nehru Buidling, Post Graduate Institute Of Medical Education and Reasearch, Sector 12, Chandigarh

Chandigarh
CHANDIGARH
160012
India 
Phone  9608976638  
Fax    
Email  amjadsayeed001@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Professor Divya Dahiya 
Designation  Professor 
Affiliation  PGIMER, Chandigarh 
Address  Department of General Surgery, 5th floor, Nehru Buidling, Post Graduate Institute Of Medical Education and Reasearch, Sector 12, Chandigarh

Chandigarh
CHANDIGARH
160012
India 
Phone  9501583520  
Fax    
Email  dahiyadivya30@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Professor Divya Dahiya 
Designation  Professor 
Affiliation  PGIMER, Chandigarh 
Address  Department of General Surgery, 5th floor, Nehru Buidling, Post Graduate Institute Of Medical Education and Reasearch, Sector 12, Chandigarh

Chandigarh
CHANDIGARH
160012
India 
Phone  9501583520  
Fax    
Email  dahiyadivya30@gmail.com  
 
Source of Monetary or Material Support  
Post Graduate Institute of Medical Education and Research, Chandigarh 
 
Primary Sponsor  
Name  Dr Amjad Sayeed 
Address  Department of general surgery, 5th floor, Nehru Building Post Graduate Institute Of Medical Education and Research, Sector 12, Chandigarh PIN: 160012 
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 Amjad Sayeed  Postgraduate Institute of Medical Education and Researcgh, Chandigarh  Dept of General Surgery, Block B, 5th floor, Nehru Hospital, POGIMER, Chandigarh
Chandigarh
CHANDIGARH 
09608976639

amjadsayeed001@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee (intramural)  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 
Comparator Agent  Drain placement without flap fixation  After modified radical mastectomy, the flaps will not be fixed. Only suction drain will be placed. 
Intervention  Fixation of mastectomy flap to pectoralis major followed by drain placement  After Modified radical mastectomy, the skin flap will be fixed to pectoralis major with intermittent vicryl 3-0 sutures placed approximately 2.5cm apart this will be followed by suction drain placement Frequency: This intervention will be done only once at the time of surgery Duration of intervention: The flap fixation process will take about 10 minutes. This will remain with the patient in the whole post operative period  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Female 
Details  1. Biopsy proven breast cancer patients who are scheduled for Modified Radical Mastectomy
2. Female Aged 18-60 years
3. Acceptance of the study by the patient by a valid informed consent
 
 
ExclusionCriteria 
Details  Exclusion Criteria
1. Patients who will undergo breast conservative surgery
2. Patients who will have sentinel node biopsy only
3. Patients who had breast reconstruction
 
 
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 compare the total duration of drain kept in patients undergoing modified radical mastectomy
 
at 4 weeks, 8 weeks and 12 weeks
 
 
Secondary Outcome  
Outcome  TimePoints 
To compare the total volume of drain output in patients undergoing modified radical mastectomy   at 4 weeks, 8 weeks, 12 weeks 
 
Target Sample Size   Total Sample Size="40"
Sample Size from India="40" 
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/ Phase 3 
Date of First Enrollment (India)   18/05/2024 
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="0"
Months="3"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
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 - NO
Brief Summary  

Breast cancer is the most common cancer and is the leading cause of cancer related death among women worldwide. According to the World Health Organization, the estimated number of newly diagnosed breast cancer cases worldwide was 2,26,1419 in 2020.1 Breast cancer has ranked number one cancer among Indian females with age adjusted rate as high as 25.8 per 100,000 women and mortality 12.7 per 100,000 women.2

Treatment options include surgery, chemotherapy, immunotherapy, radiation therapy, hormonal therapy, and targeted therapy. The most common type of breast surgery is either modified radical mastectomy (MRM) or breast conservative surgery (BCS) with axillary dissection. Mastectomy remains the common surgical treatment. Seroma is the most common complication following breast cancer surgery (15-85%)3 which is defined as accumulation of fluid in the dead space. Seroma forms secondary to accumulation of lymphatic fluid due to damage of lymphatic vessels after axillary dissection. Fluid collection usually occurs between pectoralis muscle and skin flap. It can also cause pain, discomfort, delays wound healing and increases the risk of infection which further increases the hospital stay and delays the start of adjuvant treatment.

Exact pathophysiology of seroma formation is not known. Several factors are held responsible for seroma formation which includes the type of surgery and extent of lymph node dissection. Type of surgical instrument used in the surgery also affects the seroma formation as use of electrocautery increases the incidence of seroma formation.4 However, various predictors have been anticipated which may contribute to seroma formation like age, high body mass index, breast volume, diabetes, hypertension, radiation, neoadjuvant chemotherapy, lymph node involvement by the tumor and the number of lymph nodes dissected during surgery.

To obliterate the dead space after surgery various mechanical and chemical methods have also been proposed which decreases the seroma formation subsequently. Ways to prevent seroma formation includes 1) external compression, 2) flap fixation, 3) use of tissue glues/ tranexamic acid 4) quilting or 5) use of closed suction wound drainage.5 Drains keep the wound dry and help flaps to stick to the chest wall. However, there are several disadvantages of prolonged drainage such as continuous discomfort to the patient, accidental slippage of drain, infection because of retrograde migration of bacteria, prolonged hospitalization or frequent visits to the hospital. 

Ideal wound closure should minimize seroma formation by holding skin flaps firmly to the chest wall and obliterating the dead space. However, there is no optimal method but one of the widely tested methods is flap fixation. In this, instead of directly closing the flaps and leaving a cavity beneath it, the flaps are first sutured to the underlying pectoralis major muscle to obliterate the dead space. There is a lack of consensus with different groups producing conflicting results about the efficacy of this technique in reducing seroma formation.

Therefore, we aim to study the effect of flap fixation on seroma formation in patients undergoing modified radical mastectomy.

 
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