Condition category
Pregnancy and Childbirth
Date applied
30/11/2007
Date assigned
30/05/2008
Last edited
08/05/2013
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

http://www.studies-obsgyn.nl/

Contact information

Type

Scientific

Primary contact

Dr Irene de Graaf

ORCID ID

Contact details

Spaarnepoort 1
Hoofddorp
2134 TM
Netherlands

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 measures

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

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

http://www.studies-obsgyn.nl/

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

Results - basic reporting

Publication summary

1. 2012 results in http://www.ncbi.nlm.nih.gov/pubmed/22910336

Publication citations

  1. 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.

Additional files

Editorial Notes