Cesarean Section, Cicatrix
Conditions
Keywords
cicatrix, cesarean section, sutures, surgical staples, postoperative pain, Infection
Brief summary
The Purpose of this study is to compare two methods for closure of the skin after caesarean section on the same patient; staples and subcuticular sutures. The study is performed on two separate groups of patients: 1. Woman having cesarean section for the first time and have not previously had abdominal surgery through a lower abdominal transverse incision. 2. Woman, who have previously had a caesarean section done. The following parameters are registered: 1. An objective evaluation of the two ends of the scar 6 months postoperatively. 2. A patient evaluation of the two ends of the scar 6 months postoperatively. 3. The difference in pain in the two ends of the scar 1 day postoperatively (blinded). 4. The difference in pain in the two ends of the scar 7 days, 3 and 6 months postoperatively. 5. The rate of infection.
Interventions
PROCEDUREStaples left, subcuticular suture right
Closure of the skin after cesarean section with staples on the left side of the wound and subcuticular suture on the right side.
PROCEDURESubcuticular suture left side and staples right
Closure of the skin after cesarean section with staples on the right side of the wound and subcuticular suture on the left side.
Sponsors
University of Copenhagen
Region Zealand
Holbaek Sygehus
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Woman having elective or level III caesarean section. Level III caesarean section is defined as being ordered more than 30 minutes before surgery is started. * Woman who speak and understand Danish * Woman who can give informed consent.
Exclusion criteria
* Level I or II caesarean section (ordered less than 30 min. before surgery is started). * Diabetics (this does not include gestational diabetes). * Infection * Regular treatment with immunosuppressives * Alcohol or drug abuse * Age under 18 * Chronic pain disease eg fibromyalgia, rheumatoid arthritis * BMI over 35 * Previous abdominal surgery through lower transverse abdominal incision (only applicable to woman having caesarean section for the first time).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Preferred side of the caesarean section scar | 6 months postoperatively | Preferred side of the scar and thereby method for closure of the skin: Staples, subcuticular suture or no difference. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The difference in pain between the two ends of the scar | 1 and 7 days postoperatively | Difference in painscore between the two ends of the scar 1st and 7th postoperative day. Pain is registered by a score on a vas-scale from 0-10. |
| Pain in the two ends of the scar | 1 and 7 days postoperatively | Pain in the two ends of the scar registered by a score on a vas-scale from 0-10 1 and 7 days postoperatively. |
| Infection | 7 days postoperatively | The rate of postoperative infection and what side of the scar - right or left -that is infected. |
| Cosmetic objective evaluation of the two ends of the scar | 6 months postoperatively | Evaluation of the right and left side of the scar respectively by two blinded doctors using the Singer's scar evaluation scale . Difference in Singer's score between the two ends of the scar. |
| Comparison of outcome measures in woman with no previous abdominal surgery and woman with previous caesarean section. | 6 months | Primay and Secondary outcome measures are compared in the two groups of patients. |
Countries
Denmark
Outcome results
None listed