Subcuticular Suture Versus Staples for Closure of the Skin After Caesarean Section.
- Conditions
- Cesarean SectionCicatrix
- Interventions
- Procedure: Staples left, subcuticular suture rightProcedure: Subcuticular suture left side and staples right
- Registration Number
- NCT01217567
- Lead Sponsor
- Holbaek Sygehus
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 60
- 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.
- 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).
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 1st c-section, no previous lower abdominal surgery - s.l. Staples left, subcuticular suture right - Woman with previous ceasarean section - staples left Staples left, subcuticular suture right - 1st c-section, no previous lower abdominal surgery Subcuticular suture left side and staples right - Woman with previous ceasarean section Subcuticular suture left side and staples right -
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method The difference in pain between the two ends of the scar 3 and 6 months postoperatively Difference in painscore between the two ends of the scar 3 and 6 months postoperatively. Pain is registered by a score on a vas-scale from 0-10.
Pain in the two ends of the scar 3 and 6 months postoperatively Pain in the two ends of the scar registered by a score on a vas-scale from 0-10 3 and 6 months postoperatively.
Infection 3 and 6 months 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.
Trial Locations
- Locations (1)
Department of Gynaechology and Obstetrics, Holbæk Sygehus
🇩🇰Holbæk, Denmark