Surgical WoundCesareanNCT05458518
Caesarean Wound Dressing Removal Study
A study testing Cesarean wound dressing removal in people with Surgical Wound and Surgical Wound Infection, run by Hospital Kemaman at 1 site in Malaysia.
Trial summary
An open labelled randomised trial on the timing of wound dressing removal for emergency caesarean delivery in labour. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Surgical Wound, Surgical Wound Infection, Cesarean Section Complications
- What is being tested?
- Cesarean wound dressing removal
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 294 participants
- Where
- 1 siteMalaysia
- Study dates
- 1 Aug 2022to 31 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age 18-50
- Lower segment caesarean delivery
- Primary or repeat caesarean delivery
- Caesarean section in active phase of labour.
- Regional anaesthesia
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomised Controlled Trial on the Timing of Wound Dressing Removal After Emergency Caesarean Delivery
An open labelled randomised trial on the timing of wound dressing removal for emergency caesarean delivery in labour.
Read the 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
- Being tested
- Cesarean wound dressing removal
- Keywords
- wound dressing, cesarean
- Medical subject headings
- Surgical Wound, Surgical Wound Infection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cesarean wound dressing removalProcedure or surgery
The cesarean wound dressing is to be removed and the surgical wound exposed
| Study group | Role | What they receive |
|---|---|---|
| Dressing removal at 24 hours | Active comparator | The wound dressing will be removed 24 hours after emergency cesarean delivery Receives: Procedure: Cesarean wound dressing removal |
| Dressing removal at 48 hours | Placebo comparator | The wound dressing will be removed 48 hours after emergency cesarean delivery Receives: Procedure: Cesarean wound dressing removal |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cesarean wound complication
Hematoma, seroma, wound infection, wound dehiscence
Measured: 30 days
Secondary outcomes (2)
Pain control
Perceived pain after caesarean according to Visual Analogue Scale (0/10 = no pain; 10/10 = worst pain)
Measured: 48 hours
Self hygiene
Timing of first bath after surgery
Measured: 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2022
- Study start1 Aug 2022
- Primary completion25 Sep 2024
- Study completion31 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Surgical WoundStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 294 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Kemaman
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zahar Azuar Zakaria, Hospital Kemaman
- Investigators
- Zahar A Zakaria, MD, Principal investigator, Hospital Kemaman
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05458518
- Sponsor's protocol ID
- NMRR ID-22-00321-NZM
- Acronym
- Cesarean
- Status last verified
- Jan 2025
- First submitted
- 4 Jul 2022
- Last updated
- 16 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 27018465Kilic 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.
PubMed 32312139Tan 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.
PubMed 32202035Zhang 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.
PubMed 32266018
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised Controlled Trial on the Timing of Wound Dressing Removal After Emergency Caesarean Delivery
- ClinicalTrials.gov ID
- NCT05458518
- Acronym / sponsor ID
- Cesarean / NMRR ID-22-00321-NZM
- Keywords
- wound dressing, cesarean
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 294 participants (actual)
- Lead sponsor
- Hospital KemamanUniversity, hospital or other
- Study start
- 1 Aug 2022 (actual)
- Primary completion
- 25 Sep 2024 (actual)
- Study completion
- 31 Dec 2024 (actual)
- First posted
- 14 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dressing removal at 24 hours | Active comparator | Procedure: Cesarean wound dressing removalThe wound dressing will be removed 24 hours after emergency cesarean delivery |
| Dressing removal at 48 hours | Placebo comparator | Procedure: Cesarean wound dressing removalThe wound dressing will be removed 48 hours after emergency cesarean delivery |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Age 18-50
- Lower segment caesarean delivery
- Primary or repeat caesarean delivery
- Caesarean section in active phase of labour.
- Regional anaesthesia
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cesarean wound dressing removalThe cesarean wound dressing is to be removed and the surgical wound exposed | Procedure or surgery | Dressing removal at 24 hours, Dressing removal at 48 hours |
Primary outcome
Cesarean wound complication
Time frame: 30 days
Hematoma, seroma, wound infection, wound dehiscence
2 secondary outcomes
Pain control
Time frame: 48 hours
Self hygiene
Time frame: 48 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jan 2025.
- Results publication: PubMed 27018465Peleg 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 publication: PubMed 32312139Kilic 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 publication: PubMed 32202035Tan 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 publication: PubMed 32266018Zhang 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Zahar A Zakaria, MD principal investigator
Hospital Kemaman
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cesarean wound dressing removal in people with Surgical Wound and Surgical Wound Infection, run by Hospital Kemaman at 1 site in Malaysia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Malaysia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cesarean wound complication (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05458518, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jan 2025.