NCT05458518

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
294

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2022

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 4, 2022

Completed
10 days until next milestone

First Posted

Study publicly available on registry

July 14, 2022

Completed
18 days until next milestone

Study Start

First participant enrolled

August 1, 2022

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 25, 2024

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2024

Completed
Last Updated

January 16, 2025

Status Verified

January 1, 2025

Enrollment Period

2.2 years

First QC Date

July 4, 2022

Last Update Submit

January 15, 2025

Conditions

Surgical WoundSurgical Wound InfectionCesarean Section Complications

Keywords

wound dressingcesarean

Outcome Measures

Primary Outcomes (1)

  • Cesarean wound complication

    Hematoma, seroma, wound infection, wound dehiscence

    30 days

Secondary Outcomes (2)

  • Pain control

    48 hours

  • Self hygiene

    48 hours

Study Arms (2)

Dressing removal at 24 hours

ACTIVE COMPARATOR

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

Procedure: Cesarean wound dressing removal

Dressing removal at 48 hours

PLACEBO COMPARATOR

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

Procedure: Cesarean wound dressing removal

Interventions

Cesarean wound dressing removalPROCEDURE

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

Dressing removal at 24 hoursDressing removal at 48 hours

Eligibility Criteria

Age18 Years - 50 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Age 18-50
  • Lower segment caesarean delivery
  • Primary or repeat caesarean delivery
  • Caesarean section in active phase of labour.
  • Regional anaesthesia

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Kemaman

Kampong Kemaman, Terengganu, 24000, Malaysia

Location

Related Publications (4)

  • Peleg D, Eberstark E, Warsof SL, Cohen N, Ben Shachar I. Early wound dressing removal after scheduled cesarean delivery: a randomized controlled trial. Am J Obstet Gynecol. 2016 Sep;215(3):388.e1-5. doi: 10.1016/j.ajog.2016.03.035. Epub 2016 Mar 25.

    PMID: 27018465RESULT

  • Kilic GS, Demirdag E, Findik MF, Tapisiz OL, Sak ME, Altinboga O, Sak S, Unlu BS, Evsen MS, Zeybek B, Borahay M, Kuo YF. Impact of timing on wound dressing removal after caesarean delivery: a multicentre, randomised controlled trial. J Obstet Gynaecol. 2021 Apr;41(3):348-352. doi: 10.1080/01443615.2020.1736015. Epub 2020 Apr 21.

    PMID: 32312139RESULT

  • Tan PC, Rohani E, Lim M, Win ST, Omar SZ. A randomised trial of caesarean wound coverage: exposed versus dressed. BJOG. 2020 Sep;127(10):1250-1258. doi: 10.1111/1471-0528.16228. Epub 2020 Apr 16.

    PMID: 32202035RESULT

  • Zhang T, Zhang F, Chen Z, Cheng X. Comparison of early and delayed removal of dressing following primary closure of clean and contaminated surgical wounds: A systematic review and meta-analysis of randomized controlled trials. Exp Ther Med. 2020 May;19(5):3219-3226. doi: 10.3892/etm.2020.8591. Epub 2020 Mar 11.

    PMID: 32266018RESULT

MeSH Terms

Conditions

Surgical WoundSurgical Wound Infection

Condition Hierarchy (Ancestors)

Wounds and InjuriesWound InfectionInfectionsPostoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Zahar A Zakaria, MD

    Hospital Kemaman

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Consultant, Head of Department, Lead Investigator

Study Record Dates

First Submitted

July 4, 2022

First Posted

July 14, 2022

Study Start

August 1, 2022

Primary Completion

September 25, 2024

Study Completion

December 31, 2024

Last Updated

January 16, 2025

Record last verified: 2025-01

Data Sharing

IPD Sharing
Will not share

Locations

MY(1)