Investigation of the cosmetic result of caesarean section scars
| ISRCTN | ISRCTN54855822 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN54855822 |
| Secondary identifying numbers | N/A |
- 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
| Study design | Multicentre prospective randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Patient information short and full version, cited on the following URL: http://www.studies-obsgyn.nl/ |
| 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 | 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 study start date | 02/02/2007 |
| Completion date | 02/09/2008 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Female |
| Target number of participants | 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
Sponsor information
Academic Medical Centre (AMC) (The Netherlands)
Hospital/treatment centre
Hospital/treatment centre
c/o Irene Wiersma
Meibergdreef 9
Amsterdam
1105 AZ
Netherlands
| Website | http://www.studies-obsgyn.nl/ |
|---|---|
"ROR" |
https://ror.org/03t4gr691 |
Funders
Funder type
Hospital/treatment centre
Departments of Obstetrics and Gynaecology at:
No information available
The Spaarne Hospital (The Netherlands)
No information available
Academic Medical Centre (AMC) (The Netherlands)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | 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 |
