A clinical trial to study the effects of two skin antiseptics,Chlorhexidine and Povidone-Iodine(Betadine) in women undergoing emergency cesarean delivery.
- Conditions
- Infection of obstetric surgical wound,
- Registration Number
- CTRI/2020/06/025722
- Lead Sponsor
- AIIMS Bhubaneswar
- Brief Summary
This study is a randomized, double blind, parallel group, active controlled trial comparing the efficacy of chlorhexidine gluconate and povidone iodine as skin antiseptic for prevention of surgical site infection in women undergoing emergency caesarean delivery expecting chlorhexidine–gluconate to be superior to povidine iodine in having less incidence of SSI. The primary outcome measures will be the incidence of Surgical Site Infection. The secondary outcome measures will be the duration of hospital stay, requirement for re-suturing, re-admission resulting from infection, pyrexia.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Not Yet Recruiting
- Sex
- Female
- Target Recruitment
- 876
Antenatal women at ≥34 weeks gestational age undergoing emergency Cesarean delivery.
- 1)Patients denying consent 2)Known allergy to one or both of the agents.
- 3)Patients with skin lesions adjacent to the operative site.
- 4)Women with chorioamnionitis, pyelonephritis, urinary tract infection, and mastitis.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To estimate the incidence of surgical site infection with use of Chlorhexidinegluconate compared with povidone iodine as skin antiseptic in women undergoing emergency caesarean delivery. followed postoperatively after 48 hours,1 week and 30 days.
- Secondary Outcome Measures
Name Time Method To compare the incidence of the below outcomes 1)Duration of hospital stay.
Trial Locations
- Locations (1)
All India Institute of Medical Sciences,Bhubaneswar
🇮🇳Khordha, ORISSA, India
All India Institute of Medical Sciences,Bhubaneswar🇮🇳Khordha, ORISSA, IndiaGabbeta SpandanaPrincipal investigator8008186286gabbetaspandana94@gmail.com