Subcuticular Absorbable Staples Versus Conventional Skin Closure in Women Undergoing Cesarean Delivery

Study Overview
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Brief Summary
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Despite the high numbers of cesareans being performed, scientific evidence behind which surgical techniques are best remains uncertain. Our objective is to determine if subcuticular absorbable staples improve operative time and wound cosmetics.

Detailed Description
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This will be an open-label randomized controlled clinical trial. Women undergoing cesarean delivery will be randomized to have either standard wound closure with Monocryl suture or absorbable subcuticular staples placed by INSORB skin stapling device. The INSORB under the skin stapling device is FDA approved but not currently used as standard of care at UTMB. We will exclude women with intraamniotic infection, immunosuppression, active skin infection, those unlikely to be followed-up after delivery, or unable to provide consent.

Official Title
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Subcuticular Absorbable Staples Versus Conventional Skin Closure in Women Undergoing Cesarean Delivery: A Randomized Control Trial

Conditions
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Operative Time, Wound Heal

Intervention / Treatment
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* Device: INSORB: subcuticular stapling device
* Device: Subcuticular monocryl suture manufactured by Ethicon


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 18-50 years of age Women ≥ 24 weeks viable gestation Will be undergoing cesarean delivery Exclusion Criteria: Patient unwilling or unable to provide consent. No or very limited prenatal care or a non-resident patient who is unlikely to follow-up after delivery. Immunosuppressed subjects: i.e., taking systemic immunosuppressant or steroids (e.g. transplant subjects; not including steroids for lung maturity), HIV with CD4 <200, or other Decision not to have skin closure (e.g. secondary wound closure, mesh closure) Current skin infection Coagulopathy High likelihood of additional surgical procedure beyond cesarean (e.g. scheduled hysterectomy, tubal ligation, bowel or adnexal surgery) Incarcerated individuals Intraamniotic infection Subjects participating on other treatment trials or studies that would interfere with the current study's primary outcome.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 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: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Subjects who agree to participate in the study will be randomized to one of the two groups below in a 1/1 allocation
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Suture wound closure<br>Absorbable sutures for closure of cesarean skin incision using Monocryl manufactured by Ethicon. | Device: Subcuticular monocryl suture manufactured by Ethicon<br>* Under the skin suture placed by hand<br>|
| Experimental: Absorbable staple wound closure<br>Staples will be applied as per the manufacturer's instructions intraoperatively using INSORB device manufactured by Cooper Surgical. | Device: INSORB: subcuticular stapling device<br>* Under the skin stapling device that delivers absorbable staples<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Operating time | Total time for the procedure | Start of surgery through end of skin closure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Wound cosmesis | A digital photograph of the incision will be obtained on wound check visit POD 5-10 days and 4-6 weeks postoperative. Each photograph will be evaluated according to objective criteria (width, elevation, color, marks, and general appearance) by independent blinded research staff | Time of surgery through six weeks post partum | 
| Composite wound complication | Hematoma, seroma, dehiscence, breakdown of wound, wound infection, endometritis, sepsis, post part fevers | Time of surgery through six weeks post partum | 
| Post operative pain | Pain scale ranging from 0-10 on postoperative days 1 to 3 as well as at wound check visit recorded by nursing staff | Time of surgery through six weeks post partum | 
| Adverse events | Allergic reactions: anaphylaxis, angioedema, skin rashes, including Stevens Johnson and Toxic Epidermal Necrolysis | Time of surgery through six weeks post partum | 
| Use of resources | Hospital stay, postpartum clinic or emergency room visit within 30 days of delivery, need for imaging or other invasive procedures | Time of surgery through six weeks post partum | 
| Patient satisfaction | Questionnaire POD 2-3 (before discharge) and at wound check visit | Time of surgery through six weeks post partum |