MedPath

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

Not yet recruiting
Conditions
Infection of obstetric surgical wound,
Registration Number
CTRI/2022/02/040086
Lead Sponsor
university college of medical sciences
Brief Summary

Surgical site infections are complications associated with caesarean sectionwhich may lead to a substantial effect on the mother’s health and impose enormous demandson healthcare-system resources. Significant association has been observed between repeatcaesarean sections and wound infection. Asepsis bundle includes a set of evidence-basedmeasure that have shown a significant improvement in patient care.

The aim of this trial is to study the impact of ASEPSIS bundle on caesarean surgical site among womenundergoing repeat caesarean delivery.

Detailed Description

Not available

Recruitment & Eligibility

Status
Not Yet Recruiting
Sex
Female
Target Recruitment
130
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
  • 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.

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Numbers of patients developing surgical site infections within 30 days after caesareanAt Day 3 | At Day 14 | At Day 21 | At Day 30
delivery, defined as superficial, deep or organ space infection according to Centers forAt Day 3 | At Day 14 | At Day 21 | At Day 30
Disease Control and Prevention(CDC) and National Healthcare Safety Network (NHSN)At Day 3 | At Day 14 | At Day 21 | At Day 30
in both the groups.At Day 3 | At Day 14 | At Day 21 | At Day 30
Secondary Outcome Measures
NameTimeMethod
Length of hospital stay (in days) in both groupsat time of discharge
Number of patients undergoing resuturing in both groupswithin 30 days
Number of patients having adverse effect of bundle componentsat baseline
Organism isolated in pus cultureat time of infection

Trial Locations

Locations (1)

UCMS and GTB Hospital

🇮🇳

East, DELHI, India

UCMS and GTB Hospital
🇮🇳East, DELHI, India
Dr Akshita Kamboj
Principal investigator
09728462069
akshita_kamboj@outlook.com

MedPath

Empowering clinical research with data-driven insights and AI-powered tools.

© 2025 MedPath, Inc. All rights reserved.