| CTRI Number |
CTRI/2024/12/078660 [Registered on: 27/12/2024] Trial Registered Prospectively |
| Last Modified On: |
26/12/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A study involving comparison of cefazolin alone versus azithromycin plus cefazolin in preventing surgical site infections in patients undergoing cesarean section |
|
Scientific Title of Study
|
Single dose cefazolin versus azithromycin plus cefazolin prophylaxis in preventing surgical site infection in patients undergoing cesarean section: A single blind randomised clinical 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 Mansi |
| Designation |
First Year Junior Resident |
| Affiliation |
All India Institue of Medical Sciences , Bathinda |
| Address |
DEPARTMENT OF OBSTETRICS AND GYNAECOLOGY , AIIMS BATHINDA , Bathinda PUNJAB ,151001
India
Bathinda PUNJAB 151001 India |
| Phone |
8264520219 |
| Fax |
|
| Email |
mansi170998@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Lajya Devi Goyal |
| Designation |
Professor and Head |
| Affiliation |
All India Institue of Medical Sciences ,Bathinda |
| Address |
DEPARTMENT OF OBSTETRICS AND GYNAECOLOGY ,AIIMS BATHINDA
Bathinda ,PUNJAB ,151001
India
Bathinda PUNJAB 151001 India |
| Phone |
9417658846 |
| Fax |
|
| Email |
lajja.goyal@rediffmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Lajya Devi Goyal |
| Designation |
Professor and Head |
| Affiliation |
All India Institue of Medical Sciences ,Bathinda |
| Address |
DEPARTMENT OF OBSTETRICS AND GYNAECOLOGY ,AIIMS BATHINDA
Bathinda ,PUNJAB ,151001
India
Bathinda PUNJAB 151001 India |
| Phone |
9417658846 |
| Fax |
|
| Email |
lajja.goyal@rediffmail.com |
|
|
Source of Monetary or Material Support
|
| ALL INDIA INSTITUTE OF MEDICAL SCIENCES ,BATHINDA |
|
|
Primary Sponsor
|
| Name |
NIL |
| Address |
NIL |
| Type of Sponsor |
Other [NIL] |
|
|
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 Mansi |
All India Institute of Medical Sciences ,Bathinda |
Department of Obstetrics and Gynaecology, All India Institute of Medical Sciences ,Bathinda Bathinda PUNJAB |
8264520219
mansi170998@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: O900||Disruption of cesarean delivery wound, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Group A - Only Cefazolin |
Inj cefazolin 1 gm iv will be given 30 mins prior to skin incision as prophylactic antibiotic in patients undergoing cesarean section in Group A |
| Intervention |
Group B - Azithromycin and cefazolin both |
Inj cefazolin 1 gm iv followed by azithromycin 500 mg in 100 ml NS over 10-15 mins , 30 mins prior to skin incision will be given as prophylactic antibiotic in patients undergoing cesarean section in Group B |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Day(s) |
| Age To |
45.00 Day(s) |
| Gender |
Female |
| Details |
Singleton and multiple pregnant women who will undergo emergency or elective cesarean section after taking their consent will be included in the study. |
|
| ExclusionCriteria |
| Details |
Vertical Incision
Hypersensitivity history for azithromycin or cefazolin.
Azithromycin use in past 7 days before randomisation.
Intrauterine death/Fetal Death
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
To compare the efficiency of azithromycin plus cefazolin versus only single dose cefazolin in preventing surgical site infection in patients undergoing cesarean section
|
To compare the efficiency of azithromycin plus cefazolin versus only single dose cefazolin in preventing surgical site infection in patients undergoing cesarean section
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To assess the microbiological pattern in causing surgical site infections in both groups.
To study the duration of hospital stay of patients who received cefazolin plus azithromycin as compared to the patients who received only single dose cefazolin.
|
To compare the efficiency of azithromycin plus cefazolin versus only single dose cefazolin in preventing surgical site infection in patients undergoing cesarean section
|
|
|
Target Sample Size
|
Total Sample Size="176" Sample Size from India="176"
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)
|
31/01/2025 |
| 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 a detailed history and physical examination of the pregnant female of more than 28 weeks period of gestation and considering inclusion and exclusion criteria, participants will be recruited for the study. A participant information form will be given to the participants and after a verbal explanation about the study , written informed consent in patient’s vernacular language will be taken. The demographic history , menstrual history, contraceptive history, obstetric history, personal and family history of the participant will be taken. A detailed examination of the patient will be done which will include general physical examination, respiratory, cardiovascular, abdominal, neurological and pelvic examination which will include per speculum and per vaginum examination, if required. All routine investigations like complete blood count (CBC), Random blood sugar (RBS), urine routine and microscopy (URINE R/M), serum electrolytes (SE), liver and renal function test (L/R FT), blood group (ABORH), coagulation profile, viral markers, pus or urine culture and sensitivity and obstetric ultrasonography if required will be done. Randomisation will be done by using computer generated random number tables. All eligible participants who gave consent for the study will be randomly allocated to group A (receiving only cefazolin) or group B (receiving azithromycin and cefazolin). | Treatment Arms | | | Group A | Receiving only cefazolin | | Group B | Receiving Azithromycin and cefazolin both | | Treatment Arm | Intervention | | Group A | Inj cefazolin 1 gm iv , 30 mins prior to skin incision | | Group B | Inj cefazolin 1 gm iv followed by azithromycin 500 mg in 100 ml NS over 10-15 mins , 30 mins prior to skin incision |
Both groups will receive same level of post operative care and will be assessed for 42 days for SSI. On POD 3 OT dressing will be removed and wound will be assed. Based on the findings wound will be assigned as healthy or SSI.Wound will be reassessed on POD 5 , 7. If SSI present, will treat accordingly and if healthy patient will be discharged after suture removal on POD 7. Follow up of 42 days will be done , and rest of the follow up will be done telephonically. Data will be collected using a structured proforma. |