Tissue Adhesive vs. Sterile Strips After Cesarean Delivery

Study Overview
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Brief Summary
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The goal of this project is to identify a strategy to reduce wound complications in women who undergo cesarean delivery by Pfannenstiel skin incision. Currently, many Pfannenstiel skin incisions are closed by subcuticular sutures followed by either placement of sterile strips or tissue A\adhesive. Either sterile strips or tissue adhesive can be placed over the wound as a covering but it is unclear which may reduce wound complication rates. The hypothesis of this study is that tissue adhesive will result in a reduction in wound complication rates when compared to sterile strips. Previously published studies in non-obstetric populations have identified tissue adhesive as a potential intervention to reduce wound complications. The eligible population for this study will include women at NorthShore University HealthSystem Evanston Hospital and University of Chicago Hospital who will undergo primary or repeat cesarean delivery via Pfannenstiel skin incision. Women in the study will be randomized to receive either sterile strips or tissue adhesive. The primary outcome to be evaluated will be a composite of wound complication which will include drainage, cellulitis, hematoma, seroma and/or wound separation (partial or complete). Secondary endpoints to be investigated include cosmetic outcome, patient satisfaction, cost comparison, and difference in operative times.

Official Title
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Tissue Adhesive Compared to Sterile Strips After Cesarean Delivery: A Randomized Controlled Trial

Conditions
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Wound Complication, Complications; Cesarean Section

Intervention / Treatment
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* Device: Tissue Adhesive
* Device: Sterile strips


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Women undergoing Pfannenstiel Cesarean delivery Exclusion Criteria: Inability to provide informed consent in English Planned use of staples for skin closure Unavailability of research personnel to accomplish consent and randomization at the time of cesarean
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: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Tissue Adhesive<br>Tissue Adhesive will be placed over subcuticular suture closure. | Device: Tissue Adhesive<br> <br> * Other names: 2-octyl cyanoacrylate;|
| Active Comparator: Steri-Strips<br>Sterile strips will be placed over subcuticular suture closure. | Device: Sterile strips<br> <br> * Other names: Steri-Strips;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Wound Complication | Wound drainage, Cellulitis, Abscess, Hematoma, Seroma or Separation | 6-8 weeks from cesarean delivery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Readmission for Wound Complication |  | Within 8 weeks from cesarean delivery | 
| Satisfaction With Cesarean Scar | The investigators will be using a modified validated Patient Scar Assessment Scale (PSAS) which assessed scar-related pain, itchiness, color, stiffness, irregularity and overall satisfaction with the scar. Each item on the PSAS has a 10-point scale, with 10 indicating the highest symptom severity or lowest satisfaction. The median score for each item was compared between groups. Please see website in links section for more details on this assessment tool. | 6-8 weeks from cesarean delivery | 
| Number of Participants Who Required an Office or Emergency Department Visit for Wound Complication | The investigators will review medical records to assess for ambulatory visits for wound complaints | Within 8 weeks of delivery | 
| Operative Time | The investigators will review operative records to assess operative time | At time of delivery | 
| Number of Participants Requiring Antibiotic Treatment for Wound Complication | The investigators will review medical records to assess for antibiotic prescriptions for wound complications | Within 8 weeks of delivery |