Postoperative Pain and Skin Closure Methods After Cesarean Section

Study Overview
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Brief Summary
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The study is looking at women undergoing cesarean section delivery of their baby. The purpose of this research study is to determine what type of skin closure after cesarean section helps decrease pain level the most and improves the appearance of the incision site. The study hypothesis is to determine if skin closure with absorbable subcuticular staples leads to improved cosmesis and/or decreased post-operative pain. Participants in the study will already be scheduled for a cesarean section for delivery of their baby. They will be randomized into one of three groups, 1) Insorb (absorbable subcuticular stapes), 2) Vicryl suture or 3) Monocryl suture for the skin closure of their cesarean section. Information that will be recorded includes amount of pain medication usage while in the hospital after cesarean section, daily patient rated pain score until discharge from hospital, pain score 6 weeks after surgery and cesarean section cosmetic scar 6 weeks after surgery.

Detailed Description
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Cesarean delivery is the most common surgical procedure performed in the United States, with over 1 million procedures performed per year. Based on recent Centers for Disease Control National Vital Statistics Report 32.3% of all births in the United States were via cesarean delivery, marking the twelfth consecutive annual increase in the cesarean delivery rate. Given the high numbers of cesarean deliveries being performed today, there has been interest in optimizing surgical techniques. Several recent reviews have summarized the evidence for various steps of cesarean delivery, but surprisingly in many cases there is little scientific evidence on which to base the choice of surgical technique. The topic of skin closure after cesarean delivery is an area that has been the focus of several randomized control trials. The trials compared surgical steel staples to subcuticular suture of various materials focusing on differences in post-operative pain, infection rates, and scar cosmesis. Cosmesis has been investigated in all three Randomized Clinical Trials and none have found differences between surgical steel staples and subcuticular suture. Infection rate has been studied in a single observational study which found a higher infection rate in those patients whose skin was closed with surgical steel staples compared to suture. Studies of post-operative pain and skin closure technique have been contradictory. The earliest Randomized clinical trial to investigate skin closure and post-operative pain was done by Frishman et al (5) and found that subjective self-assessment of pain was better at hospital discharge and 6 weeks post-operatively in patients when subcuticular suture rather than surgical steel staples were used. A subsequent Randomized clinical trial reported the opposite result with less pain 6 weeks post-operatively when surgical steel staples were used. This discrepancy may, in part, be due to the different suture material used in the two trials. The study by Frishman et al which showed a benefit of subcuticular suture utilized used polyglycolic acid (Vicryl suture or Insorb staples); whereas, the study by Rousseau et al used polyglecaprone (Monocryl suture). To date direct comparison of skin closure at the time of cesarean with these two suture materials has not been performed. Recently, a new technology for skin closure has been introduced that employs absorbable material, polylactic and polyglycolic acid, in subcuticular staples. In animal models this method of skin closure has shown less histological inflammation and fewer wound infections than either surgical steel staples or subcuticular suture. Unfortunately, little is known about how this skin closure technique compares to the other more established techniques after cesarean delivery in humans. However, a retrospective analysis comparing subcuticular absorbable staples with surgical steel staples revealed an association between subcuticular absorbable staples and decreased in-hospital analgesic use. The current study is a prospective randomized trial that investigates four cesarean skin closure techniques-surgical steel staples, subcuticular polyglycolic acid suture (Vicryl), subcuticular, polyglecaprone suture (Monocryl), and absorbable subcuticular polyglycolic acid staples-to determine if one is associated with improved cosmesis or a decrease in post-operative pain.

Official Title
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Post-Operative Pain and Skin Closure Methods After Cesarean Section

Conditions
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Pregnancy

Intervention / Treatment
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* Procedure: Insorb staples skin closure
* Procedure: Monocryl skin closure
* Procedure: Vicryl skin closure


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 18-44 Any race Any parity Scheduled Cesarean Section Neuraxial analgesia Exclusion Criteria: Diabetes Mellitus Maternal Connective Tissue Disorder Maternal Steroid Use

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 44 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: Factorial Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: INSORB staples skin closure<br>Women undergoing cesarean section delivery will have skin closure with INSORB staples. | Procedure: Monocryl skin closure<br>* Patients will be randomized to Monocryl skin closure and compared to Insorb skin closure and Vicryl skin closure.<br>Procedure: Vicryl skin closure<br>* Patients will be randomized to Vicryl skin closure and compared to Insorb and Monocryl skin closure groups.<br>|
| Active Comparator: Monocryl skin closure<br>Women undergoing cesarean section delivery will have skin closure with Monocryl. | Procedure: Insorb staples skin closure<br>* Patients will be randomized to Insorb staples skin closure and compared to Monocryl and Vicryl group.<br>Procedure: Vicryl skin closure<br>* Patients will be randomized to Vicryl skin closure and compared to Insorb and Monocryl skin closure groups.<br>|
| Active Comparator: Vicryl skin closure<br>Women undergoing cesarean section delivery will have Vicryl skin closure | Procedure: Insorb staples skin closure<br>* Patients will be randomized to Insorb staples skin closure and compared to Monocryl and Vicryl group.<br>Procedure: Monocryl skin closure<br>* Patients will be randomized to Monocryl skin closure and compared to Insorb skin closure and Vicryl skin closure.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intravenous and analgesic use. | Record the amount of in hospital intravenous and oral analgesic use. | Admission for delivery of baby by cesarean section to expected postpartum average of 6 weeks | 
| Daily subjective pain score while hospitalized | Daily patient rated subjective pain score (0-10 based on visual analog scale) until dismissal from the hospital will be recorded. | Hospital admission for cesarean section delivery | 
| 6 week postoperative subjective pain score | Patient rated subjective pain score 6 weeks postoperatively will be recorded. | After cesarean section delivery at the 6 week postpartum visit | 
| Scar cosmetic score 6 weeks post-operatively. | 6 weeks post-operative scar cosmetic score will be recorded. | 6 weeks post-operatively after cesarean section | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Wound complications | Wound complications (infection, separation, or seroma) | Time of cesarean section until 6 weeks postpartum visit | 
| Length of hospital stay | Length of hospital stay | C/S admission to discharge time | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pregnancy, Pregnant, Cesarean Section Delivery