Caesarean Wound Dressing Removal Study

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

Detailed Description
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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

Official Title
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A Randomised Controlled Trial on the Timing of Wound Dressing Removal After Emergency Caesarean Delivery

Conditions
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Surgical Wound, Surgical Wound Infection, Cesarean Section Complications

Intervention / Treatment
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* Procedure: Cesarean wound dressing removal


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 18-50 Lower segment caesarean delivery Primary or repeat caesarean delivery Caesarean section in active phase of labour. Regional anaesthesia Exclusion Criteria: Upper segment or classical caesarean delivery Massive postpartum haemorrhage > 1.5 litre Pre-delivery chorioamnionitis Skin closure using interrupted suture Acquired or congenital coagulation disorder Associated medical or obstetric condition requiring prolonged hospital stay after delivery such as severe pre-eclampsia, uncontrolled diabetes mellitus, cardiac disease, systemic infection. Inability to give consent

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Dressing removal at 24 hours<br>The wound dressing will be removed 24 hours after emergency cesarean delivery | Procedure: Cesarean wound dressing removal<br>* The cesarean wound dressing is to be removed and the surgical wound exposed<br>|
| Placebo Comparator: Dressing removal at 48 hours<br>The wound dressing will be removed 48 hours after emergency cesarean delivery | Procedure: Cesarean wound dressing removal<br>* The cesarean wound dressing is to be removed and the surgical wound exposed<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cesarean wound complication | Hematoma, seroma, wound infection, wound dehiscence | 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain control | Perceived pain after caesarean according to Visual Analogue Scale (0/10 = no pain; 10/10 = worst pain) | 48 hours | 
| Self hygiene | Timing of first bath after surgery | 48 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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wound dressing, cesarean