Caesarean Wound Dressing Removal Study (Cesarean)

July 12, 2022 updated by: Zahar Azuar Zakaria, Hospital Kemaman

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

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

294

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Malaysia
    • Terengganu
      • Kampong Kemaman, Terengganu, Malaysia, 24000

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital Kemaman

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2022

Primary Completion (Anticipated)

June 30, 2023

Study Completion (Anticipated)

June 30, 2023

Study Registration Dates

First Submitted

July 4, 2022

First Submitted That Met QC Criteria

July 12, 2022

First Posted (Actual)

July 14, 2022

Study Record Updates

Last Update Posted (Actual)

July 14, 2022

Last Update Submitted That Met QC Criteria

July 12, 2022

Last Verified

July 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NMRR ID-22-00321-NZM

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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