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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.

Phase 2
Not yet recruiting
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
Inclusion Criteria

Antenatal women at ≥34 weeks gestational age undergoing emergency Cesarean delivery.

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.

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
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
NameTimeMethod
To compare the incidence of the below outcomes1)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, India
Gabbeta Spandana
Principal investigator
8008186286
gabbetaspandana94@gmail.com

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