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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  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
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.

 
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