| CTRI Number |
CTRI/2017/02/007790 [Registered on: 06/02/2017] Trial Registered Retrospectively |
| Last Modified On: |
03/02/2017 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Use of Peroperative Antibiotics in Patients Undergoing Surgery For Breast Cancer |
|
Scientific Title of Study
|
Effect Of Antibiotic Prophylaxis In Patients Undergoing Modified Radical Mastectomy - A Randomized Double-Blinded Clinical Trial |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Galidevara Indira |
| Designation |
Senior Resident |
| Affiliation |
JIPMER |
| Address |
Department Of General Surgery, JIPMER, Pondicherry.
Pondicherry
PONDICHERRY
605006
India |
| Phone |
9500990403 |
| Fax |
|
| Email |
g.indira.surg@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Manwar S Ali |
| Designation |
Assistant Professor |
| Affiliation |
JIPMER |
| Address |
Department Of General Surgery, JIPMER, Pondicherry.
Pondicherry
PONDICHERRY
605006
India |
| Phone |
9488820340 |
| Fax |
|
| Email |
alysmanwar@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Galidevara Indira |
| Designation |
Senior Resident |
| Affiliation |
JIPMER |
| Address |
Department Of General Surgery, JIPMER, Pondicherry.
Pondicherry
PONDICHERRY
605006
India |
| Phone |
9500990403 |
| Fax |
|
| Email |
g.indira.surg@gmail.com |
|
|
Source of Monetary or Material Support
|
| Jawaharlal Institute of Postgraduate Medical Education and Research,
Dhanavanthri nagar,
Pondicherry-605006 |
|
|
Primary Sponsor
|
| Name |
JIPMER |
| Address |
Jawaharlal Institute of Postgraduate Medical Education and Research, Dhanavanthri nagar, Pondicherry-605006 |
| 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 |
| Galidevara Indira |
ward 34,37,Department Of General Surgery , |
Jawaharlal Institute of Postgraduate Medical Education and Research
general surgery department ward34 ,37
Pondicherry
PONDICHERRY |
9500990403
g.indira.surg@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| JIPMER Institute Ethics Committee (Human Studies) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Patients with proven diagnosis of carcinoma breast planned for modified radical mastectomy as decided by institute tumor board, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
INJECTION CEFAZOLIN |
1gm Cefazolin diluted in 10ml of distilled water and administered intravenously at the time of induction of anaesthesia |
| Comparator Agent |
NORMAL SALINE |
10 ml of intravenous injection of normal saline (0.9%NS) at the time of induction of anesthesia |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
PATIENTS WHO ARE DIAGNOSED CASES OF CARCINOMA BREAST WHO ARE PLANNED TO UNDERGO MODIFIED RADICAL MASTECTOMY AS DECIDED BY THE INSTITUTE TUMOR BOARD |
|
| ExclusionCriteria |
| Details |
Exclusion criteria
1. Hypersensitivity to intravenous Cefazolin
2. Patients receiving antibiotics for some other reason
3. Patients with local skin infections at the site of surgery
4. Patients on steroids
5. Immunosuppressive disease(HIV)
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Rate of Surgical Site Infection according to CDC definition |
30 Days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Detecting potential risk factors in the development of surgical site infection |
30 Days |
|
|
Target Sample Size
|
Total Sample Size="200"
Sample Size from India="200"
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
01/01/2013 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="2"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
| Surgical site infection (SSI) is a major source of adverse operation-related event in patients undergoing surgery, including increased morbidity, additional cost and delay of postoperative adjuvant therapies. Till date no single study has been done exclusively defining the role of antibiotic prophylaxis in patients undergoing modified radical mastectomy (MRM) in India.The aim of this randomized clinical trial is to determine whether prophylactic antibiotics are indicated in patients undergoing MRM and to identify the risk factors that increase the rate of post operative SSI. | |