Caesarean Wound Dressing Removal Study

Not Applicable

Completed

• Conditions: Surgical Wound; Surgical Wound Infection; Cesarean Section Complications

• Registration Number: NCT05458518
• Lead Sponsor: Hospital Kemaman

Brief Summary

An open labelled randomised trial on the timing of wound dressing removal for emergency caesarean delivery in labour.

Detailed Description

The trial is unblinded randomised trial on surgical wound dressing at 24 versus 48 hours after the emergency caesarean delivery in labour.

The primary outcome is the prevalence of wound complications (hematoma, seroma, infection/ dehiscence) The secondary objectives are the maximum pain after the surgery (in ward) and the timing of the patient's first bath after the surgery

Study Timeline

• Study First Submitted: 2022-07-04
• Study First Submitted QC: 2022-07-12
• Study First Posted: 2022-07-14
• Study Start: 2022-08-01
• Primary Completion: 2024-09-25
• Study Completion: 2024-12-31
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-15
• Last Update Posted: 2025-01-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 294

Inclusion Criteria

1. Age 18-50
2. Lower segment caesarean delivery
3. Primary or repeat caesarean delivery
4. Caesarean section in active phase of labour.
5. Regional anaesthesia

Exclusion Criteria

1. Upper segment or classical caesarean delivery
2. Massive postpartum haemorrhage > 1.5 litre
3. Pre-delivery chorioamnionitis
4. Skin closure using interrupted suture
5. Acquired or congenital coagulation disorder
6. Associated medical or obstetric condition requiring prolonged hospital stay after delivery such as severe pre-eclampsia, uncontrolled diabetes mellitus, cardiac disease, systemic infection.
7. Inability to give consent

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Cesarean wound complication	30 days	Hematoma, seroma, wound infection, wound dehiscence

Secondary Outcome Measures

Name	Time	Method
Pain control	48 hours	Perceived pain after caesarean according to Visual Analogue Scale (0/10 = no pain; 10/10 = worst pain)
Self hygiene	48 hours	Timing of first bath after surgery

Trial Locations

Locations (1)

Hospital Kemaman; 🇲🇾 Kampong Kemaman, Terengganu, Malaysia