Clinical trial NCT05458518: Caesarean Wound Dressing Removal Study
Official title: A Randomised Controlled Trial on the Timing of Wound Dressing Removal After Emergency Caesarean Delivery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Surgical Wound
Surgical Wound Infection
Cesarean Section Complications
Keywords: wound dressing
cesarean
Lead sponsor: Hospital Kemaman
Sponsor class: OTHER
First posted: 2022-07-14
Enrollment: 294
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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

Eligibility criteria: 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

Primary outcomes:
measure: Cesarean wound complication
timeFrame: 30 days
Secondary outcomes:
measure: Pain control
timeFrame: 48 hours
measure: Self hygiene
timeFrame: 48 hours
Other outcomes:
Locations:
city: Kampong Kemaman
country: Malaysia
facility: Hospital Kemaman
state: Terengganu
Study officials:
affiliation: Hospital Kemaman
name: Zahar A Zakaria, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
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.