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A clinical trial to study the effect of aseptic measures on the surgical wound of repeat caesarean deliveries

Impact of asepsis bundle on cesarean surgical site among women undergoing repeat caesarean delivery

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2022/02/040086
Enrollment
130
Registered
2022-02-07
Start date
Unknown
Completion date
Unknown
Last updated
2022-10-17

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: ASEPSIS Bundle group: 1.No Hair removal or with clippers 2.Preoperative bath with 4% chlorhexidine. 3.Antimicrobial prophylaxis with cefazolin. 4. Skin preparation with 4% chlorhexidine

Sponsors

university college of medical sciences
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1.Pregnant women with period of gestation more than 28 weeks undergoing elective 2.repeat caesarean section not in labor. 3.History of previous one or two caesarean sections 4.Willing to follow up in UCMS & GTB Hospital.

Exclusion criteria

Exclusion criteria: 1. Patients with leaking per vaginum or chorioamnionitis 2. Patients with the following high risk factors at the time of recruitment will be excluded 2a Moderate or Severe anemia 2b Gestational or pre-gestational diabetes mellitus 2c Immunocompromised patients 2d BMI >30 kg/m2 2e Smoking 3 Patients with history of surgical site infection in the previous caesarean scar. 4 Any skin condition around surgical site 5 Patients allergic to chlorhexidine

Design outcomes

Primary

MeasureTime frame
Numbers of patients developing surgical site infections within 30 days after caesarean delivery, defined as superficial, deep or organ space infection according to Centers for Disease Control and Prevention(CDC) and National Healthcare Safety Network (NHSN) in both the groups.Timepoint: At Day 3 At Day 14 At Day 21 At Day 30

Secondary

MeasureTime frame
Length of hospital stay (in days) in both groupsTimepoint: at time of discharge;Number of patients having adverse effect of bundle componentsTimepoint: at baseline;Number of patients undergoing resuturing in both groupsTimepoint: within 30 days;Organism isolated in pus cultureTimepoint: at time of infection

Countries

India

Contacts

Public ContactAkshita Kamboj

UCMS and GTB hospital, new delhi

gautamdrricha1@gmail.com7011484180

Outcome results

None listed

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