Caesarean Wound Dressing Removal Study

NCT ID: NCT05458518

Last Updated: 2025-01-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

294 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-08-01

Study Completion Date

2024-12-31

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

Conditions

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Surgical Wound Surgical Wound Infection Cesarean Section Complications

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Dressing removal at 24 hours

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

Group Type ACTIVE_COMPARATOR

Cesarean wound dressing removal

Intervention Type PROCEDURE

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

Dressing removal at 48 hours

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

Group Type PLACEBO_COMPARATOR

Cesarean wound dressing removal

Intervention Type PROCEDURE

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

Interventions

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Cesarean wound dressing removal

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

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Hospital Kemaman

OTHER

Sponsor Role lead

Responsible Party

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Zahar Azuar Zakaria

Consultant, Head of Department, Lead Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Zahar A Zakaria, MD

Role: PRINCIPAL_INVESTIGATOR

Hospital Kemaman

Locations

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Hospital Kemaman

Kampong Kemaman, Terengganu, Malaysia

Site Status

Countries

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Malaysia

References

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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.

Reference Type RESULT
PMID: 27018465 (View on PubMed)

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.

Reference Type RESULT
PMID: 32312139 (View on PubMed)

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.

Reference Type RESULT
PMID: 32202035 (View on PubMed)

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.

Reference Type RESULT
PMID: 32266018 (View on PubMed)

Other Identifiers

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NMRR ID-22-00321-NZM

Identifier Type: -

Identifier Source: org_study_id

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