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CTRI Number  CTRI/2025/11/098028 [Registered on: 25/11/2025] Trial Registered Prospectively
Last Modified On: 24/11/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Comparing the complications in using harmonic scalpel versus electrocautery in post modified radical mastectomy 
Scientific Title of Study   A study of complications in using harmonic scalpel versus electrocautery in post 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 Steve Dinesh Balasundar 
Designation  Post Graduate in General surgery 
Affiliation  Aarupadai Veedu medical college 
Address  Room no. 10, C block, Department of General surgery, Aarupadai Veedu medical college Pondi-Cuddalore main road, kirumampakkam, Puducherry

Pondicherry
PONDICHERRY
607403
India 
Phone  9443350139  
Fax    
Email  Dsteve880@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Ravichandran K 
Designation  Professor  
Affiliation  Aarupadai Veedu Medical College 
Address  Room no. 10, Department of General Surgery, Aarupadai Veedu Medical College, Kirumampakkam, Puducherry

Pondicherry
PONDICHERRY
607403
India 
Phone  9443350139  
Fax    
Email  drkravichandranyadav@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Steve Dinesh Balasundar 
Designation  Post Graduate in General surgery 
Affiliation  Aarupadai Veedu Medical College 
Address  Room no. 10, C-block, Department of General Surgery, Aarupadai Veedu medical college Pondi-Cuddalore main road, kirumampakkam, Puducherry

Pondicherry
PONDICHERRY
607403
India 
Phone  9443350139  
Fax    
Email  Dsteve880@gmail.com  
 
Source of Monetary or Material Support  
Aarupadai Veedu Medical College, Kirumampakkam, Pondicherry, India - 607403 
 
Primary Sponsor  
Name  Aarupadai Veedu Medical College  
Address  C block, Department of General Surgery, Aarupadai Veedu Medical College, Kirumampakkam, Pondicherry, India - 607403 
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 Steve  Aarupadai Veedu Medical College  Room no. 10, C block, Department of General surgery, Aarupadai Veedu Medical College and hospital, Kirumampakkam, Pondicherry
Pondicherry
PONDICHERRY 
9443350139

Dsteve880@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Human Ethical Commitee   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  Electrocautery  Using electrocautery during modified radical mastectomy surgery intraoperatively (during the surgery) 
Intervention  Harmonic scalpel  Using harmonic scalpel during modified radical mastectomy surgery intraoperatively (during the surgery) instead of electrocautery  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  75.00 Year(s)
Gender  Female 
Details  Patients with clinical diagnosis of stage 1,2 and 3 breast carcinoma 
 
ExclusionCriteria 
Details  Patients who had undergone breast surgery in the past
Patients with metastasis
Patients with ulcers, discharge or active wound infections in the breast
Patients with risk factors that could affect wound healing like anemia or on anticoagulant or corticosteroids therapy 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Post operative complications such as seroma formation and flap necrosis is reduced on using harmonic scalpel on comparing with electrocautery  Assessing on post operative day 1, day 2, day 7, day 14, day 21 and day 28 
 
Secondary Outcome  
Outcome  TimePoints 
Comparing the duration of the surgery, blood loss, post operative pain & days of hospital stay in using harmonic scalpel & electrocautery in modified radical mastectomy   Assessing on post operative day 1, day 3, day 7 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
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)   15/12/2025 
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)   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 - NO
Brief Summary  

After the clearance from the IRC & IEC, all the eligible patients fulfilling inclusion criteria will be admitted through outpatient department (OPD) with informed consent, on completing full workup for surgery and anesthetic fitness. Diagnosis will be confirmed by FNAC or Trucut biopsy. Patients will be divided into two groups (A & B). Group A – Surgery to be done with harmonic scalpel. Group B – Surgery to be done with electrocautery. Randomization will be performed by group allocation concealment method (i.e) Patient will be divided randomly into two groups by single blinding technique as the investigator knows which patient is alotted in which group. Both the groups will undergo standard modified radical mastectomy with lymph node dissection up to level II. Operating time in minutes from skin incision to closure was recorded. Blood loss during the surgery was estimated by weighing the dry sponges preoperatively and subtracting the weight from the weight of postoperative used sponges (using a digital weighing scale with each gram taken as equal to one millilitre of blood). Suction was not used in the surgery. The amount of blood loss was calculated as mL. Negative pressure closed suction drains will be kept in both the groups, with one tube along the lower skin flap and another tube in axilla. In post-operative period, quantity of drain will be noted every 24hr for both groups. Postoperatively our criteria for drain removal will be when drain quantity in the last 24 hours had fallen to <30ml. Development of seroma as a complication will be defined when drain quantity continued to be >40ml after postoperative day 7 or if there is clinically evident fluid collection beneath the skin flap during follow-up of patients after discharge from hospital. After removal of drain, we will follow-up for the next 12 weeks, skin flaps will be examined regularly to see any fluid collection noticing fluctuation, flap necrosis and seroma will be confirmed with aspiration of fluid. Postoperatively, wound-related pain was assessed using visual analogue scales (VAS) scored on each postoperative morning till Postoperative Day (POD) 7. Clinical assessment of the wound was done on each postoperative morning for flap necrosis and surgical site infection (SSI) till the patient was discharged and on the first follow-up visit to the hospital. All patients will be followed up on weekly basis and during each post-operative visit, the presence of seroma and flap necrosis will be assessed clinically, and the number of aspirations required for the seroma will also documented. Comparison of proportion of group A and group B will be done. Frequency and percentage will be generated for qualitative variables such as seroma formation and flap necrosis

 
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