| 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
|
|
|
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
|
|
|
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 |