| CTRI Number |
CTRI/2024/07/071644 [Registered on: 31/07/2024] Trial Registered Prospectively |
| Last Modified On: |
29/07/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Effect of one drain vs two drain on seroma formation after Modified Radical Mastectomy |
|
Scientific Title of Study
|
Evaluation of seroma formation after Modified Radical Mastectomy using single vs double drain : 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 |
SRIJITA SAHA |
| Designation |
JUNIOR RESIDENT |
| Affiliation |
Post Graduate Institute of Medical Education and Research Chandigarh |
| Address |
Department of General Surgery,5th Level, B Block , Nehru Hospital, PGIMER
CHANDIGARH
pin -160012
India
Chandigarh
CHANDIGARH
160012
India |
| Phone |
8098578421 |
| Fax |
|
| Email |
srijitasaha1998@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
PROF Divya Dahiya |
| Designation |
Professor |
| Affiliation |
Post Graduate Institute of Medical Education and Research Chandigarh |
| Address |
Department of General Surgery, Level 5, B block , Nehru hospital, PGIMER CHANDIGARH PIN -160012
Chandigarh
CHANDIGARH
160012
India |
| Phone |
9501583520 |
| Fax |
|
| Email |
dahiyadivya@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Prof Divya Dahiya |
| Designation |
Professor |
| Affiliation |
Post Graduate Institute of Medical Education and Research Chandigarh |
| Address |
Department of General Surgery, Level 5, B block , Nehru hospital, PGIMER CHANDIGARH PIN -160012
Chandigarh
CHANDIGARH
160012
India |
| Phone |
9501583520 |
| Fax |
|
| Email |
dahiyadivya@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Postgraduate Institute of Medical Education and Research, Chandigarh, India,Pin 160012 |
|
|
Primary Sponsor
|
| Name |
Postgraduate Institute of Medical Education and Research Chandigarh |
| Address |
Postgraduate Institute of Medical Education and Research Chandigarh
PIN 160012
India |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Srijita Saha |
Postgraduate Institute of Medical Education Chandigarh and Research, Chandigarh |
Room no 2, 5th level, B block, Department of General Surgery
Chandigarh
CHANDIGARH |
8098578421
srijitasaha1998@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE |
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 |
Number of days the drains are kept |
Primary objective: - To calculate the total duration of drain kept. We will quantify seroma formation based on the number of days the drains is kept in situ. Criteria for removing the drain is less than 20 cc output for 2 consecutive days.
The more number of days drain is kept, the more the seroma formation in the patient.
Secondary objective: 1)To look for the incidence of flap necrosis 2) To look for the incidence of Surgical Site Infection 3) To compare the severity of pain at drain site |
| Intervention |
Number of drains kept. |
Patients after undergoing modified radical mastectomy, drains are put , one limb in axilla and other limb beneath lower skin flap, to prevent seroma formation. In other group, only one limb of drain is kept -at the axilla for preventing seroma formation. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Female |
| Details |
Patients who have biopsy proven breast cancer who are scheduled for Modified Radical Mastectomy and give valid informed consent for the study |
|
| ExclusionCriteria |
| Details |
1)Patients who will undergo breast conservative surgery
2)Male patients with BC |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Total duration of drain kept insitu |
Till 4 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To look for flap necrosis |
Till 4 weeks |
| To look for surgical site infections |
Till 4 weeks |
| Pain at drain site |
Till drain is insitu |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
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)
|
15/08/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
15/08/2024 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="2"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
Evaluation of seroma formation after Modified Radical Mastectomy using single vs double drain. Two groups are made based on computer generated randomisation. Modified radical mastectomy done . In one group of patient, one drain placed only at the axilla. In other group, two limbs of drain is placed, one under the skin flap , other in the axilla. Seroma formation will be evaluated on the basis of drain output and number of days the drains is kept in situ. Other outcomes being evaluated are flap necrosis, surgical site infections which are all complications of seroma formation. |