| CTRI Number |
CTRI/2024/04/065465 [Registered on: 09/04/2024] Trial Registered Prospectively |
| Last Modified On: |
28/07/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Preventive |
| Study Design |
Other |
|
Public Title of Study
|
Role of topical nitroglycerin ointments to prevent flap necrosis after mastectomy surgery |
|
Scientific Title of Study
|
Role of topical nitroglycerin in the prevention and treatment of post mastectomy skin flap necrosis- a prospective comparative study |
| 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 Sumaiya Fathima |
| Designation |
Junior Resident |
| Affiliation |
Govt Stanley Medical College |
| Address |
7th floor I block
Department of General Surgery
Govt Stanley Medical College
No 1 old jail road
George Town
Chennai
Chennai
TAMIL NADU
600001
India |
| Phone |
9150250667 |
| Fax |
|
| Email |
sumiirfan336@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr B Sathyapriya |
| Designation |
Professor |
| Affiliation |
Govt Stanley Medical College |
| Address |
7th floor I block
Department of General Surgery
Govt Stanley Medical College
No 1 old jail road
George Town
Chennai
Chennai
Chennai
TAMIL NADU
600001
India |
| Phone |
94444086644 |
| Fax |
|
| Email |
drbspriya@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sumaiya Fathima |
| Designation |
Resident |
| Affiliation |
Govt Stanley Medical College |
| Address |
7th floor I block
Department of General Surgery Govt Stanley Medical College
No 1 old jail road
George Town
Chennai
Chennai
TAMIL NADU
600001
India |
| Phone |
9150250667 |
| Fax |
|
| Email |
sumiirfan336@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government Stanley Medical College |
|
|
Primary Sponsor
|
| Name |
Govt Stanley medical college |
| Address |
1 old jail road George Town chennai 600001 |
| Type of Sponsor |
Government 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 Sumaiya |
Govt Stanley medical college |
8th floor I block
Department of General Surgery 1 Old jail road George Town
Chennai
TAMIL NADU |
9150250667
sumiirfan336@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Government Stanley medical college and hospital chennai 01 Institutional ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C50||Malignant neoplasm of breast, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Povidone iodine |
To be applied topically three times a day from 2nd post operative day for 5 days |
| Intervention |
Topical nitroglycerin |
2% formulation of topical nitroglycerin to be applied topically three times a day for 5 days from 2nd post operative day |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Female |
| Details |
Patients undergoing mastectomy |
|
| ExclusionCriteria |
| Details |
History of thromboembolic events
Coronary artery disease patients
Uncontrolled comorbidities
History of hypersensitivity reactions |
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| 1. Incidence of post mastectomy skin flap necrosis in patients using topical nitroglycerin |
4 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Role of topical nitroglycerin in treating post mastectomy skin flap necrosis by preventing the progression of necrosis & reducing the need for wound debridement whe compared to povidone iodine |
4 weeks |
|
|
Target Sample Size
|
Total Sample Size="90"
Sample Size from India="90"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="60" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
30/04/2024 |
| Date of Study Completion (India) |
29/08/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
Aim to study the role of topical nitroglycerin in reducing the incidence of post mastectomy skin flap necrosis and in the treatment of the same Written and Informed consent will be obtained from all subjects before enrollment in the study A group of 90 patients will be randomized in to group A and group B of 45 each Group A will receive topical nitroglycerin tds for 6 days and group B will receive placebo for the same period patients will be followed up at weekly intervals for 4 weeks During each follow up visit the patient will be assessed for wound margin discolouration |