Subcuticular Suture Versus Staples for Closure of the Skin After Caesarean Section.

Study Overview
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Brief Summary
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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: An objective evaluation of the two ends of the scar 6 months postoperatively. A patient evaluation of the two ends of the scar 6 months postoperatively. The difference in pain in the two ends of the scar 1 day postoperatively (blinded). The difference in pain in the two ends of the scar 7 days, 3 and 6 months postoperatively. The rate of infection.

Official Title
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Subcuticular Suture Versus Staples for Closure of the Skin After Caesarean Section: A Prospective Randomized Single-blinded Case-Control Study With the Case as it's Own Control.

Conditions
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Cesarean Section, Cicatrix

Intervention / Treatment
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* Procedure: Staples left, subcuticular suture right
* Procedure: Subcuticular suture left side and staples right


Participation Criteria
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Eligibility Criteria
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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).

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1st c-section, no previous lower abdominal surgery - s.l.<br> | Procedure: Staples left, subcuticular suture right<br>* Closure of the skin after cesarean section with staples on the left side of the wound and subcuticular suture on the right side.<br>|
| Experimental: Woman with previous ceasarean section - staples left<br> | Procedure: Staples left, subcuticular suture right<br>* Closure of the skin after cesarean section with staples on the left side of the wound and subcuticular suture on the right side.<br>|
| Experimental: 1st c-section, no previous lower abdominal surgery<br> | Procedure: Subcuticular suture left side and staples right<br>* Closure of the skin after cesarean section with staples on the right side of the wound and subcuticular suture on the left side.<br>|
| Experimental: Woman with previous ceasarean section<br> | Procedure: Subcuticular suture left side and staples right<br>* Closure of the skin after cesarean section with staples on the right side of the wound and subcuticular suture on the left side.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Preferred side of the caesarean section scar | Preferred side of the scar and thereby method for closure of the skin: Staples, subcuticular suture or no difference. | 6 months postoperatively | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The difference in pain between the two ends of the scar | 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. | 1 and 7 days postoperatively | 
| The difference in pain between the two ends of the scar | 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. | 3 and 6 months postoperatively | 
| Pain in the two ends of the scar | Pain in the two ends of the scar registered by a score on a vas-scale from 0-10 1 and 7 days postoperatively. | 1 and 7 days postoperatively | 
| Pain in the two ends of the scar | Pain in the two ends of the scar registered by a score on a vas-scale from 0-10 3 and 6 months postoperatively. | 3 and 6 months postoperatively | 
| Infection | The rate of postoperative infection and what side of the scar - right or left -that is infected. | 7 days postoperatively | 
| Infection | The rate of postoperative infection and what side of the scar - right or left -that is infected. | 3 and 6 months postoperatively | 
| Cosmetic objective evaluation of the two ends of the scar | 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. | 6 months postoperatively | 
| Comparison of outcome measures in woman with no previous abdominal surgery and woman with previous caesarean section. | Primay and Secondary outcome measures are compared in the two groups of patients. | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cicatrix, cesarean section, sutures, surgical staples, postoperative pain, Infection