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Caesarean Wound Dressing Removal Study (Cesarean)

Primary Purpose

Surgical Wound, Surgical Wound Infection, Cesarean Section Complications

Status
Recruiting
Phase
Not Applicable
Locations
Malaysia
Study Type
Interventional
Intervention
Cesarean wound dressing removal
Sponsored by
Hospital Kemaman
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Surgical Wound focused on measuring wound dressing, cesarean

Eligibility Criteria

18 Years - 50 Years (Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • Hospital KemamanRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Dressing removal at 24 hours

Dressing removal at 48 hours

Arm Description

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

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

Outcomes

Primary Outcome Measures

Cesarean wound complication
Hematoma, seroma, wound infection, wound dehiscence

Secondary Outcome Measures

Pain control
Perceived pain after caesarean according to Visual Analogue Scale (0/10 = no pain; 10/10 = worst pain)
Self hygiene
Timing of first bath after surgery

Full Information

First Posted
July 4, 2022
Last Updated
July 12, 2022
Sponsor
Hospital Kemaman
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1. Study Identification

Unique Protocol Identification Number
NCT05458518
Brief Title
Caesarean Wound Dressing Removal Study
Acronym
Cesarean
Official Title
A Randomised Controlled Trial on the Timing of Wound Dressing Removal After Emergency Caesarean Delivery
Study Type
Interventional

2. Study Status

Record Verification Date
July 2022
Overall Recruitment Status
Recruiting
Study Start Date
July 1, 2022 (Actual)
Primary Completion Date
June 30, 2023 (Anticipated)
Study Completion Date
June 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hospital Kemaman

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Surgical Wound, Surgical Wound Infection, Cesarean Section Complications
Keywords
wound dressing, cesarean

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
294 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Dressing removal at 24 hours
Arm Type
Active Comparator
Arm Description
The wound dressing will be removed 24 hours after emergency cesarean delivery
Arm Title
Dressing removal at 48 hours
Arm Type
Placebo Comparator
Arm Description
The wound dressing will be removed 48 hours after emergency cesarean delivery
Intervention Type
Procedure
Intervention Name(s)
Cesarean wound dressing removal
Intervention Description
The cesarean wound dressing is to be removed and the surgical wound exposed
Primary Outcome Measure Information:
Title
Cesarean wound complication
Description
Hematoma, seroma, wound infection, wound dehiscence
Time Frame
30 days
Secondary Outcome Measure Information:
Title
Pain control
Description
Perceived pain after caesarean according to Visual Analogue Scale (0/10 = no pain; 10/10 = worst pain)
Time Frame
48 hours
Title
Self hygiene
Description
Timing of first bath after surgery
Time Frame
48 hours

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Age 18-50 Lower segment caesarean delivery Primary or repeat caesarean delivery Caesarean section in active phase of labour. Regional anaesthesia Exclusion Criteria: 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Zahar A Zakaria, MD
Phone
6098513333
Email
zazuarz@yahoo.co.uk
First Name & Middle Initial & Last Name or Official Title & Degree
Mazrin N Mohd Ali, MD
Phone
6098513333
Email
mazrin_0202@yahoo.com
Facility Information:
Facility Name
Hospital Kemaman
City
Kampong Kemaman
State/Province
Terengganu
ZIP/Postal Code
24000
Country
Malaysia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zahar A Zakaria, MD
Phone
6098513333
Email
zazuarz@yahoo.co.uk
First Name & Middle Initial & Last Name & Degree
Mazrin M Mohd Ali
Phone
6098513333
Email
mazrin_0202@yahoo.com

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
27018465
Citation
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.
Results Reference
result
PubMed Identifier
32312139
Citation
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.
Results Reference
result
PubMed Identifier
32202035
Citation
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.
Results Reference
result
PubMed Identifier
32266018
Citation
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.
Results Reference
result

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Caesarean Wound Dressing Removal Study

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