Plain English Summary
Not provided at time of registration
Trial website
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Techniques for skin closure after a caesarean: the cosmetic result
Acronym
SCACS-trial (Skin Closure After Caesarean Section)
Study hypothesis
We hypothesise that closure of the fat layer and closure of the skin with a suture will yield a better cosmetic result.
Ethics approval
Ethics approval received from the Medical Ethical Commission of the VU Medical Centre on the 23rd November 2006 (ref: 2005/205).
Study design
Multicentre prospective randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Patient information short and full version, cited on the following URL: http://www.studies-obsgyn.nl/
Condition
Caesarean section
Intervention
Pre-operative the patient will be randomly assigned to four categories:
1. No closure of the fat layer and skin closure with staples
2. No closure of the fat layer and skin closure with stitches
3. Closure of the fat layer and skin closure with staples
4. Closure of the fat layer and skin closure with stitches
The primary outcome is the cosmetic result measured with the Patient and Observer Scar Assessment Scale, in which the patient and the investigator complete a questionnaire. The wound assessment will be performed six months after the caesarean. Secondary outcomes include post-operative pain, wound complications, such as dehiscence, infection, seroma or haematoma, material reaction, operating time for the skin closure and costs.
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measure
Cosmetic outcome, measured with the Patient and Observer Scar Assessment Scale six months after caesarean.
Secondary outcome measures
1. Post-operative pain
2. Operating time
3. Costs
4. Wound complications, such as infection, dehiscence, haematoma and seroma
Overall trial start date
02/02/2007
Overall trial end date
02/09/2008
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Pregnant women
2. Older than eighteen years
3. Planned for having a caesarean section
4. Give informed consent
Participant type
Patient
Age group
Adult
Gender
Female
Target number of participants
125
Participant exclusion criteria
Women with a previous abdominal operation, including caesarean section.
Recruitment start date
02/02/2007
Recruitment end date
02/09/2008
Locations
Countries of recruitment
Netherlands
Trial participating centre
Spaarnepoort 1
Hoofddorp
2134 TM
Netherlands
Sponsor information
Organisation
Academic Medical Centre (AMC) (The Netherlands)
Sponsor details
c/o Irene Wiersma
Meibergdreef 9
Amsterdam
1105 AZ
Netherlands
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Hospital/treatment centre
Funder name
Departments of Obstetrics and Gynaecology at:
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
The Spaarne Hospital (The Netherlands)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Academic Medical Centre (AMC) (The Netherlands)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
1. 2012 results in http://www.ncbi.nlm.nih.gov/pubmed/22910336
Publication citations
-
Results
de Graaf IM, Oude Rengerink K, Wiersma IC, Donker ME, Mol BW, Pajkrt E, Techniques for wound closure at caesarean section: a randomized clinical trial., Eur. J. Obstet. Gynecol. Reprod. Biol., 2012, 165, 1, 47-52, doi: 10.1016/j.ejogrb.2012.07.019.