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Een keizerlijk litteken

 

Sluiten van de subcutis en cutis bij sectio caesarea: het cosmetisch resultaat

Techniques for skin closure: the cosmetic result

 

Go to the Keizerlijk litteken website.

 

 

Research question
To compare the effects of skin closure techniques and materials on maternal outcomes; primary the cosmetic result, secondary postoperative pain, wound complications, material reactions, operating time and costs.

 

Background

Caesarean section is the commonest major operation performed on women in the world. In most countries between 5 and 20% of all deliveries are by elective or emergency caesarean section. (1) The techniques used for caesarean sections appear to vary between obstetricians. There is currently no conclusive evidence about how the skin should be closed after caesarean section.

In this investigation the patient will be randomised in four categories, where the fat layer will or will not be closed and the skin will be closed with stitches or staples. The cosmetic outcome will be evaluated 6 months after the caesarean using the Patient and Observer Scar Assessment Scale. The cosmetic result will be the primary outcome, also postoperative pain, operating time, costs and wound complications will be studied.

 

Study design

Multicentre prospective randomised controlled trial

 

Selection criteria

Inclusion criteria: Pregnant women planned for having a caesarean section who give informed consent.

Exclusion criteria: Women with a previous abdominal operation, including caesarean section.

 

Randomisation

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.

 

Outcome

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 6 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.

 

Sample size

For the power analysis we assumed that a score less than or equal to eighteen is an attractive scar and a score of greater than or equal to thirty is an unattractive scar. The total mean score in a pilot study was 18 by patients with an attractive scar and 32 by an unattractive scar. Assuming that in the intervention group 5% of the patients and in the control group 25% of the patients will have an unattractive scar, the mean score of the intervention and the control group will be respectively 18,7 and 21,5. To demonstrate a difference in the groups by an expected standard deviation of 4 a minimum of 25 patients per group are needed (beta .20, alpha .05). Considering a loss of 30% of participating patients during follow-up, a total of approximately 125 participants is needed.  

 

Project leaders

Dr. I.M. de Graaf, gynaecologist, Spaarne ziekenhuis Hoofddorp

Dr. E. Pajkrt, gynaecologist, AMC Amsterdam

Drs. I.C. Wiersma, AMC Amsterdam

 

Participating hospitals

Hoofddorp – Spaarne ziekenhuis

Amsterdam –Academisch Medisch Centrum

 

Contact

Drs. I.C. Wiersma Academisch Medisch Centrum

Dept. Obstetry & Gynaecology, H4-205

Meibergdreef 9

1105 AZ Amsterdam

i.c.wiersma@amc.uva.nl