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Completed

NCT Number: NCT05458518

Caesarean Wound Dressing Removal Study

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

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Key information

Conditions

Surgical Wound Cesarean Section Complications Infections Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Surgical Wound Infection Wound Infection Wounds and Injuries

Age range

18 year–50 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Hospital Kemaman

Kampong Kemaman, Terengganu, 24000, Malaysia

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cesarean wound dressing removal

Procedure

The cesarean wound dressing is to be removed and the surgical wound exposed

Primary outcomes

  1. Cesarean wound complication

    Time frame: 30 days

    Hematoma, seroma, wound infection, wound dehiscence

Secondary outcomes

  1. Pain control

    Time frame: 48 hours

    Perceived pain after caesarean according to Visual Analogue Scale (0/10 = no pain; 10/10 = worst pain)

  2. Self hygiene

    Time frame: 48 hours

    Timing of first bath after surgery

Sponsors and collaborators

Lead sponsor

Hospital Kemaman

Other

Registry information

Official study title

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

Acronym: Cesarean

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Jul 14, 2022
Registry last updated
Jan 16, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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