Investigation of the cosmetic result of caesarean section scars
| ISRCTN | ISRCTN54855822 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN54855822 |
| Protocol serial number | N/A |
| Sponsor | Academic Medical Centre (AMC) (The Netherlands) |
| Funders | Departments of Obstetrics and Gynaecology at:, The Spaarne Hospital (The Netherlands), Academic Medical Centre (AMC) (The Netherlands) |
- Submission date
- 30/11/2007
- Registration date
- 30/05/2008
- Last edited
- 08/05/2013
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Pregnancy and Childbirth
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Irene de Graaf
Scientific
Scientific
Spaarnepoort 1
Hoofddorp
2134 TM
Netherlands
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Multicentre prospective randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Study type | Participant information sheet |
| Scientific title | Techniques for skin closure after a caesarean: the cosmetic result |
| Study acronym | SCACS-trial (Skin Closure After Caesarean Section) |
| Study objectives | We hypothesise that closure of the fat layer and closure of the skin with a suture will yield a better cosmetic result. |
| Ethics approval(s) | Ethics approval received from the Medical Ethical Commission of the VU Medical Centre on the 23rd November 2006 (ref: 2005/205). |
| Health condition(s) or problem(s) studied | 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 |
| Primary outcome measure(s) |
Cosmetic outcome, measured with the Patient and Observer Scar Assessment Scale six months after caesarean. |
| Key secondary outcome measure(s) |
1. Post-operative pain |
| Completion date | 02/09/2008 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Female |
| Target sample size at registration | 125 |
| Key inclusion criteria | 1. Pregnant women 2. Older than eighteen years 3. Planned for having a caesarean section 4. Give informed consent |
| Key exclusion criteria | Women with a previous abdominal operation, including caesarean section. |
| Date of first enrolment | 02/02/2007 |
| Date of final enrolment | 02/09/2008 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
Spaarnepoort 1
Hoofddorp
2134 TM
Netherlands
2134 TM
Netherlands
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/11/2012 | Yes | No | |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
| Study website | Study website | 11/11/2025 | 11/11/2025 | No | Yes |
