Study Results
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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COMPLETED
NA
294 participants
INTERVENTIONAL
2022-08-01
2024-12-31
Brief Summary
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Detailed Description
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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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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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Dressing removal at 24 hours
The wound dressing will be removed 24 hours after emergency cesarean delivery
Cesarean wound dressing removal
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
Cesarean wound dressing removal
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
Eligibility Criteria
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Inclusion Criteria
2. Lower segment caesarean delivery
3. Primary or repeat caesarean delivery
4. Caesarean section in active phase of labour.
5. Regional anaesthesia
Exclusion Criteria
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
18 Years
50 Years
FEMALE
Yes
Sponsors
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Hospital Kemaman
OTHER
Responsible Party
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Zahar Azuar Zakaria
Consultant, Head of Department, Lead 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
Countries
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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.
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.
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.
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.
Other Identifiers
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NMRR ID-22-00321-NZM
Identifier Type: -
Identifier Source: org_study_id
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