Cesarean: Caesarean Wound Dressing Removal Study

• Sponsor: Hospital Kemaman (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05458518
• Collaborator: (none)
• Enrollment: 294
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 12
• Patients Per Site Per Month: 24.6

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Surgical Wound; Surgical Wound Infection; Cesarean Section Complications	Procedure: Cesarean wound dressing removal	N/A

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 Design

• Study Type: Interventional
• Anticipated Enrollment: 294 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Prevention
• Official Title: A Randomised Controlled Trial on the Timing of Wound Dressing Removal After Emergency Caesarean Delivery
• Actual Study Start Date: Jul 1, 2022
• Anticipated Primary Completion Date: Jun 30, 2023
• Anticipated Study Completion Date: Jun 30, 2023

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Cesarean wound complication [30 days]

   Hematoma, seroma, wound infection, wound dehiscence

Secondary Outcome Measures

1. Pain control [48 hours]

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

2. Self hygiene [48 hours]

   Timing of first bath after surgery

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 50 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hospital Kemaman	Kampong Kemaman	Terengganu	Malaysia	24000

Sponsors and Collaborators

• Hospital Kemaman

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Zahar Azuar Zakaria, Consultant, Head of Department, Lead Investigator, Hospital Kemaman
• ClinicalTrials.gov Identifier: NCT05458518
• Other Study ID Numbers: NMRR ID-22-00321-NZM
• First Posted: Jul 14, 2022
• Last Update Posted: Jul 14, 2022
• Last Verified: Jul 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Zahar Azuar Zakaria, Consultant, Head of Department, Lead Investigator, Hospital Kemaman: wound dressing; cesarean
• Additional relevant MeSH terms: Wound Infection; Surgical Wound Infection; Wounds and Injuries; Surgical Wound

Study Results

No Results Posted as of Jul 14, 2022