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
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
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