A Clinical Trial of Subcuticular Staples Versus Subcuticular Suture for Cesarean Section Skin Closure

Study Overview
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Brief Summary
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Currently, the way doctors close the skin during cesarean section is different between surgeons and there is little evidence to support the use of one kind of closure over the other. At the Mayo Clinic Family Birth Center, skin is currently closed using an absorbable suture (or stitch), placed within the top layer of skin. At other institutions, a metal staple is often used to close the skin. There is a new technique that uses special absorbable staples just beneath the skin. This technology may be equal to, or possibly better than, current skin closure techniques. However, there is currently little data to show how it compares. The purpose of this study is to compare the absorbable staple to the currently used absorbable suture. The data from this study will then be used to help determine the best technique for skin closure.

Detailed Description
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Cesarean section is one of the most frequently performed surgical procedures worldwide. In the United States, the proportion of deliveries by cesarean has increased from approximately 21% in 1996 to 32.8% in 2010. Ultimately, the rising incidence of cesarean delivery results in increased surgical morbidity; including pain, blood loss, and surgical site infections, which leads to an increase in overall hospitalization days and healthcare costs. This volume of surgical procedures also carries the risk of blood and body fluid exposures to surgical staff. Suture needles contribute to 43.4% of all sharps injuries in surgical settings and 51.5% of sharp injuries to surgeons alone. Additionally, it was discovered that 20% of blood borne pathogen exposures on the Mayo Clinic Rochester campus in 2011 occurred in the Department of Obstetrics and Gynecology. Therefore, any quality improvement measure regarding cesarean sections has the potential to significantly impact overall surgical morbidity, bloodborne pathogen exposure, and healthcare costs at our institution. Reviews of current literature show a lack of evidence for many of the surgical steps during cesarean procedures. Thus, there is an urgent need to define evidence-based surgical techniques for each step, from incision to closure. The optimal skin closure technique is simple, quick, cost-effective, and provides adequate tissue approximation with a good cosmetic outcome while minimizing the risk of infection, dehiscence, and pain. Ideally, needlestick injuries would also be eliminated. It is currently unknown which skin closure method is superior with regard to these outcomes. The INSORB 20 (Incisive Surgical) is a new, single-use device for skin closure that aims to combine the speed of a staple with the cosmetic outcome of a subcuticular suture, while eliminating the need for staple removal. Additionally, it should reduce the incidence of needlestick injury. INSORB also claims to result in a low maintenance wound with less surgical site infection, lower inflammation, and increased patient comfort and satisfaction. However, data is limited comparing INSORB to the current standards of care (either staples or suture). The purpose of this study is to determine if the new absorbable subcuticular staples (INSORB) improves outcomes compared to the current standard absorbable subcuticular suture for skin closure in cesarean sections.

Official Title
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A Randomized Clinical Trial of Subcuticular Staples Versus Subcuticular Suture for Cesarean Section Skin Closure

Conditions
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Surgical Wound

Intervention / Treatment
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* Device: Subcuticular suture
* Device: Subcuticular staple


Participation Criteria
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Eligibility Criteria
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Inclusion criteria: Gestational age ≥ 24 weeks Scheduled cesarean section for any indication Pfannenstiel incision Singleton gestation Exclusion criteria: Failure to consent Gestational age < 24 weeks Vaginal delivery Intrauterine fetal death Multifetal gestation Suspected infection, i.e. chorioamnionitis BMI > 50

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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Subcuticular suture<br>Subcuticular suture has been used for many years to close skin incisions. | Device: Subcuticular suture<br>* subcuticular Monocryl suture closure<br>* Other names: Monocryl;|
| Active Comparator: Subcuticular staple<br>Subcuticular staples are a newer modality than suture, but are currently an accepted and widely used skin closure technique. | Device: Subcuticular staple<br>* subcuticular staple wound closure with INSORB 20 device<br>* Other names: Insorb;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total Surgical Time, All Resident Levels | Total surgical time was defined as the time from incision start to incision completion. Measured for all resident education levels (1 to 4 years postgraduate). | Measured at the time of the procedure (day 1), approximately 1 hour after incision start | 
| Skin Closure Time, All Resident Levels | Measured for all resident education levels (1 to 4 years postgraduate). | Measured at the time of the procedure (day 1), approximately 1 hour after incision start | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total Number of Participants With Postoperative Complications | Postoperative complications were assessed by chart review. | From the day of the procedure (Day 1) for 6 weeks | 
| Participants With Postoperative Complications, by Type | Postoperative complications were assessed by chart review. | From the day of the procedure (Day 1) for 6 weeks | 
| Postoperative Pain | Post-operative pain was assessed by pain medication use through chart review. | From day of procedure until end of hospital stay (typical dismissal on day 4) | 
| Number of Subjects Requiring Patient-controlled, Alternative Oral, or Single Dose IV/IM Analgesic | Post-operative pain was assessed by pain medication use through chart review. These subjects required patient-controlled analgesia, or alternative oral analgesic, or a single dose of intravenous (IV) or intramuscular (IM) analgesic. Alternative oral analgesics included hydromorphone, hydrocodone/acetaminophen, or oxycodone/acetaminophen . | From day of procedure until end of hospital stay (typical dismissal on day 4) | 
| Patient Satisfaction | Patient satisfaction was measured by questionnaire at the time of dismissal from the hospital and at their 6 week postpartum/postoperative exam. There were 4 questions: How satisfied are you with the appearance of your skin incision? How willing are you to recommend this same skin closure to a friend? How willing are you to have this same skin closure for your next cesarean section? What is your overall satisfaction with your surgical procedure, including the skin incision? For reporting purposes, possible answers for each item were grouped into negative (not at all, not very, or no opinion), or positive (somewhat or extremely). | At the time of dismissal (typically day 3 or 4) and at 6 weeks postoperative appointment | 
| Surgeon Satisfaction (Per Procedure) | Surgeon satisfaction was assessed by a 3-question questionnaire immediately after performing the procedure. The questions were: How satisfied are you with the appearance of the skin incision? How willing are you to recommend this skin closure (whether it was staples or suture) to a patient? How willing are you to use this skin closure (whether it was staples or suture) for your next cesarean section? There were 5 possible responses to each question (not at all, not very, no opinion, somewhat, extremely), with not at all,' not very, and no opinion being a negative response, and somewhat and extremely  being a positive response. Categories reported were negative, (including no opinion), and positive. | Immediately after the procedure (day 1) | 
| Cosmetic Outcome | The cosmetic outcome will be assessed by patients and a blinded observer at the 6 week postpartum/postoperative exam using the Patient Observer Scar Assessment Scale (POSAS). The POSAS consists of two parts: a Patient Scale and an Observer Scale. Both scales contain six items that are scored numerically. Each item of both scales has a 10-point score, with 10 indicating the worst imaginable scar or sensation. The lowest score is '1', and corresponds to the situation of normal skin (normal pigmentation, no itching etc), and goes up to the worst imaginable. Besides the six items the 'Overall Opinion' of the scar quality is scored separately of both patients and observers. Again, a 10-point scale is used in which 10 corresponds to the worst imaginable scar. | Measured at 6 week postoperative appointment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Subcuticular suture, Subcuticular staple, Skin closure, Incision closure, Wound