Caesarean Wound Dressing Removal Study

Cesarean Section Complications Clinical Trial

— Cesarean  

Official title:

A Randomised Controlled Trial on the Timing of Wound Dressing Removal After Emergency Caesarean Delivery

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05458518
• Other study ID #: NMRR ID-22-00321-NZM
• Status: Recruiting
• Phase: N/A
• Start date: July 1, 2022
• Est. completion date: June 30, 2023

Study information

• Verified date: July 2022
• Source: Hospital Kemaman
• Contact: Zahar A Zakaria, MD
• Phone: 6098513333
• Email: zazuarz[@]yahoo.co.uk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 294
• Est. completion date: June 30, 2023
• Est. primary completion date: June 30, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Cesarean Section Complications
• Surgical Wound
• Surgical Wound Infection
• Wound Infection
• Wounds and Injuries

Intervention

Procedure:
• Cesarean wound dressing removal
The cesarean wound dressing is to be removed and the surgical wound exposed

Locations

Country	Name	City	State
Malaysia	Hospital Kemaman	Kampong Kemaman	Terengganu

Sponsors (1)

Lead Sponsor	Collaborator
Hospital Kemaman

Country where clinical trial is conducted

Malaysia, 

References & Publications (4)

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. 20 — View 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. — View 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. — View 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) — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cesarean wound complication	Hematoma, seroma, wound infection, wound dehiscence	30 days
Secondary	Pain control	Perceived pain after caesarean according to Visual Analogue Scale (0/10 = no pain; 10/10 = worst pain)	48 hours
Secondary	Self hygiene	Timing of first bath after surgery	48 hours