Single dose cefazolin versus azithromycin plus cefazolin prophylaxis in preventing surgical site infection in patients undergoing cesarean section: A single blind randomised clinical trial

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.