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A clinical trial to study the effects of two skin antiseptics, Chlorhexidine and Povidone-Iodine(Betadine) in women undergoing emergency cesarean delivery.

Comparing the efficacy of Chlorhexidine Gluconate Versus Povidone-Iodine as Skin Antiseptic for prevention of Surgical Site Infection in women undergoing emergency Caesarean Delivery: A Randomized Control Trial

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2020/06/025722
Enrollment
876
Registered
2020-06-09
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: O860- Infection of obstetric surgical wound

Interventions

Intervention1: Chlorhexidine gluconate IP equivalent to 0.5% w/v of chlorhexidine gluconate and Isopropyl Alcohol 70% v/v purified water IP q.s.: Skin preparation will be done by centrifugal scrubbin

Sponsors

AIIMS Bhubaneswar
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Antenatal women at >=34 weeks gestational age undergoing emergency Cesarean delivery

Exclusion criteria

Exclusion criteria: 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.

Design outcomes

Primary

MeasureTime frame
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.Timepoint: followed postoperatively after 48 hours,1 week and 30 days.

Secondary

MeasureTime frame
To compare the incidence of the below outcomes 1)Duration of hospital stay. 2)Requirement for re-suturing. 3)Re-admission resulting from infection. 4)Pyrexia. Timepoint: followed postoperatively after 48 hours, 1 week and 30 days.

Countries

India

Contacts

Public ContactGabbeta Spandana

All India Institute of Medical Sciences, Bhubaneswar

drpruthwiraj@gmail.com9438884132

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026