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
Name Time Method Numbers of patients developing surgical site infections within 30 days after caesarean At Day 3 | At Day 14 | At Day 21 | At Day 30 delivery, defined as superficial, deep or organ space infection according to Centers for At 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
Name Time Method Length of hospital stay (in days) in both groups at time of discharge Number of patients undergoing resuturing in both groups within 30 days Number of patients having adverse effect of bundle components at baseline Organism isolated in pus culture at time of infection
Trial Locations
- Locations (1)
UCMS and GTB Hospital
🇮🇳East, DELHI, India
UCMS and GTB Hospital🇮🇳East, DELHI, IndiaDr Akshita KambojPrincipal investigator09728462069akshita_kamboj@outlook.com