Caesarean Wound Dressing Removal Study (Cesarean)

Hospital Kemaman

Status: Completed

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

Treatments: Procedure: Cesarean wound dressing removal

Study type: Interventional

Funder types: Other

Identifiers

NCT05458518

NMRR ID-22-00321-NZM

Details and patient eligibility

About

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

Full 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

Enrollment: 294 patients

Sex: Female

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

294 participants in 2 patient groups, including a placebo group

Dressing removal at 24 hours

Active Comparator group

Description:

The wound dressing will be removed 24 hours after emergency cesarean delivery

Treatment:

Procedure: Cesarean wound dressing removal

Dressing removal at 48 hours

Placebo Comparator group

Description:

The wound dressing will be removed 48 hours after emergency cesarean delivery

Treatment:

Procedure: Cesarean wound dressing removal