Condition category
Pregnancy and Childbirth
Date applied
11/04/2016
Date assigned
13/04/2016
Last edited
31/10/2016
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

Background and study aims
A caesarean is an operation used to deliver a baby, which can be planned or used as an emergency procedure, when a natural birth is not an option. It involves making a cut in the mother’s tummy (abdomen) wall and the womb, through which the baby is taken through. Following a caesarean delivery, there is a risk that the surgical wound can become infected (surgical site infection, SSI). The skin usually acts as a barrier against infection, protecting the blood and internal organs. Following surgery however, bacteria can potentially enter the body through the surgical site, causing an infection. Wound dressings are commonly used to prevent infections of surgical sites in adults however this practice is controversial, as there is not enough evidence showing that wound dressings can help prevent surgical site infections (SSI). The aim of this study is to find out whether leaving the surgical site exposed following a caesarean section leads to a lower amount of SSI’s than if the wound is dressed following surgery.

Who can participate?
Pregnant women aged 18 and over who are having a caesarean section

What does the study involve?
Participants are randomly allocated to one of two groups. For those in the first group, the wound from the caesarean section is left uncovered following the procedure. For those in the second group, the wound from the caesarean section is covered after the surgery using a standard wound dressing for 24 hours following surgery, after which it is left uncovered. For participants in both groups, the wounds are examined 24 hours after surgery and when the patient is discharged. Patients are also contacted by telephone 14 and 28 days after surgery in order to find out whether they are satisfied with their treatment and if they have had any infections. The amount of women who develop SSI’s in each group is then compared 28 days after surgery.

What are the possible benefits and risks of participating?
Not provided at time of registration.

Where is the study run from?
University Malaya Medical Centre (Malaysia)

When is the study starting and how long is it expected to run for?
January 2016 to July 2016

Who is funding the study?
University of Malaya (Malaysia)

Who is the main contact?
Professor Tan Pend Chiong

Trial website

Contact information

Type

Public

Primary contact

Prof Tan Peng Chiong

ORCID ID

Contact details

Obstetrics and Gynaecology department
University Malaya Medical Centre
Kuala Lumpur
51100
Malaysia

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Caesarean section Wound: Exposed compared to Dressed - A randomised trial

Acronym

C-WED

Study hypothesis

Superficial surgical site infection rate is lower when the Caesarean section (transverse suprapubic) wound is left exposed compared to dressed at the completion of surgery.

Ethics approval

Medical Ethics Committee of University Malaya Medical Center, 26/03/2016, ref: 20161-2112

Study design

Prospective 2-arm open label randomised controlled trail

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet.

Condition

Caesarean section wound care

Intervention

Participants are randomly allocated to one of two groups.

Group 1: The transverse suprapubic Caesarean wound is left exposed after completion of skin closure (wound to be left exposed permanently).

Group 2: The transverse suprapubic Caesarean wound is covered after completion of skin closure with a commercially purchased standard wound dressing (dressing to be removed at 24 hours and subsequently left exposed).

Participants in both groups have their wounds assessed at 24 hours and the time of discharge and are followed up by telephone at 14 and 28 days post-surgery.

Intervention type

Procedure/Surgery

Phase

Drug names

Primary outcome measures

1. Caesarean wound surgical site infection rate is assessed using physical examinations on day 1 and at time of discharge and through telephone interviews on day 14 and 28
2. Patient’s satisfaction with wound management is determined using a visual numerical rating score (VNRS) at hospital discharge

Secondary outcome measures

1. Wound pain is measured using a visual numerical rating score (VNRS) on day 1
2. Pain on the process of wound exposure (i.e. dressing removal compared to exposing wound by lifting clothes in the uncovered wound arm) is measured using a visual numerical rating score (VNRS) on day 1
3. Need for surgical gauze application to absorb wound exudate or need for dressing (in exposed arm) or dressing change (in dressed arm)
4. Patient preferences for exposed/dressed wound care are determined using a questionnaire specifically designed for the study on day 28
5. Satisfaction with Caesarean wound rated using a 11 point VNRS is measured using telephone interviews on day 14 and 28

Overall trial start date

01/01/2016

Overall trial end date

31/07/2017

Reason abandoned

Eligibility

Participant inclusion criteria

1. Age 18 years old or more
2. Undergoing Caesarean section
3. Tested negative for HIV and Hepatitis B in current pregnancy

Participant type

Patient

Age group

Adult

Gender

Female

Target number of participants

334

Participant exclusion criteria

1. Known infectious person particularly if infected with organism transmissible by blood or bodily secretions
2. Category 1 (very urgent) caesarean section
3. Need for compressive wound dressing as per surgeon’s direction
4. Caesarean section requiring midline incision

Recruitment start date

15/04/2016

Recruitment end date

30/04/2017

Locations

Countries of recruitment

Malaysia

Trial participating centre

University Malaya Medical Centre
Jalan Lembah Pantai
Kuala Lumpur
51000
Malaysia

Sponsor information

Organisation

University of Malaya

Sponsor details

Lembah Pantai
Kuala Lumpur
50603
Malaysia

Sponsor type

University/education

Website

Funders

Funder type

University/education

Funder name

Universiti Malaya

Alternative name(s)

University of Malaya, UM

Funding Body Type

government organisation

Funding Body Subtype

government non-federal

Location

Malaysia

Results and Publications

Publication and dissemination plan

Intends to publish findings in an academic research journal

Intention to publish date

01/09/2017

Participant level data

Not expected to be available

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes

06/06/2016: The recruitment end date has been amended from 30/04/2016 to 30/04/2017 and the overall trial end date had been amended from 31/07/2016 to 31/07/2017.