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Wound cleaning after C-section: comparing chlorhexidine to saline or sterile water

Chlorhexidine vs normal saline or sterile water for post-operative caesarean section wound cleansing: a randomised controlled trial

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN98807753
Enrollment
870
Registered
2023-12-11
Start date
2024-01-01
Completion date
Unknown
Last updated
2024-01-08

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

Conditions

Cleaning of the caesarean wound in the first 5 days Pregnancy and Childbirth

Interventions

Participants were randomly assigned to the following treatment arms using Block Randomisation: 1. Chlorhexidine (0.05% solution) 2. Normal saline (0.9% sodium chloride solution) or water (50:50 split)

Sponsors

University Malaya Medical Centre
Lead Sponsor

Eligibility

Sex/Gender
Female

Inclusion criteria

Inclusion criteria: 1. Aged 18 years and above 2. Caesarean section (CS) (planned or unplanned) 3. Within 24 hours of CS 4. Complete skin closure 5. Access to telephone 6. Can communicate in Malay or English

Exclusion criteria

Exclusion criteria: 1. Wound issue (gape, discharge, pain, tenderness, redness, swelling, heat) 2. Hypersensitivity or allergy to chlorhexidine 3. Fever (>38°C) in the last 48 hours 4. Chorioamnionitis or suspected chorioamnionitis 5. Wound haematoma or bruising

Design outcomes

Primary

MeasureTime frame
The cumulative superficial surgical site infection rates measured by the care provider and by self-reporting through telephone interviews from surgery to 30 days after surgery

Secondary

MeasureTime frame
The following secondary outcome measures are assessed by the care provider and by self-reporting through telephone interview (Day 30): In hospital, evaluation: 1. Before discharge, the wound will be assessed using the CDC criteria for diagnosing superficial surgical site infection by care provider (at hospital discharge) Measured after hospital discharge by telephone interview: 1. Superficial surgical site infection measured using a telephone-based questionnaire adapted from CDC criteria by self-reporting (Day 15 and 30) 2. Satisfaction with wound healing measured using an 11-point (0-10) numerical rating scale (NRS) by self-grading (Day 15 and 50) 3. Compliance with twice daily wound cleansing in the first 5 days (at least 80% of 10 planned episodes) protocol measured using self-reporting (Day 15) 4. Satisfaction with wound appearance measured using an 11-point (0-10) NRS to rate, by self-grading (Day 30) 5. ‘I will recommend my allocated wound cleansing solution to a friend’ measured using a 5-grade Likert scale (strongly agree, agree, neutral, disagree or strongly disagree response) by self-grading (Day 15)

Countries

Malaysia

Contacts

Public ContactAmsavalli;Tan Sundaresan;Peng Chiong

;

s2030629@ummc.edu.my;pctan@um.edu.my+60 (0)3-79494422;+60 (0)3-79494422

Outcome results

None listed

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