A study comparing wound care techniques following Caesarean section
| ISRCTN | ISRCTN15071530 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN15071530 |
| Secondary identifying numbers | N/A |
- Submission date
- 11/04/2016
- Registration date
- 13/04/2016
- Last edited
- 02/09/2020
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Pregnancy and Childbirth
Plain English summary of protocol
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
Contact information
Public
Obstetrics and Gynaecology department
University Malaya Medical Centre
Kuala Lumpur
51100
Malaysia
Study information
| Study design | Prospective 2-arm open label randomised controlled trail |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet. |
| Scientific title | Caesarean section Wound: Exposed compared to Dressed - A randomised trial |
| Study acronym | C-WED |
| Study objectives | 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(s) | Medical Ethics Committee of University Malaya Medical Center, 26/03/2016, ref: 20161-2112 |
| Health condition(s) or problem(s) studied | 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 |
| Primary outcome measure | 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 study start date | 01/01/2016 |
| Completion date | 31/07/2017 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Female |
| Target number of participants | 334 |
| Total final enrolment | 331 |
| Key inclusion criteria | 1. Age 18 years old or more 2. Undergoing Caesarean section 3. Tested negative for HIV and Hepatitis B in current pregnancy |
| Key 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 |
| Date of first enrolment | 15/04/2016 |
| Date of final enrolment | 30/04/2017 |
Locations
Countries of recruitment
- Malaysia
Study participating centre
Kuala Lumpur
51000
Malaysia
Sponsor information
University/education
Lembah Pantai
Kuala Lumpur
50603
Malaysia
"ROR" |
https://ror.org/00rzspn62 |
|---|
Funders
Funder type
University/education
Government organisation / Universities (academic only)
- Alternative name(s)
- University of Malaya, University Malaya, Malayan University, UM
- Location
- Malaysia
Results and Publications
| Intention to publish date | 01/09/2017 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not expected to be made available |
| Publication and dissemination plan | Intends to publish findings in an academic research journal |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/09/2020 | 02/09/2020 | Yes | No |
Editorial Notes
02/09/2020: Publication reference and total final enrolment number added.
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.
