Tissue Adhesive vs. Sterile Strips After Cesarean Delivery

Not Applicable

Terminated

Brief Summary: 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.

Recruitment & Eligibility

Inclusion Criteria

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

Arm && Interventions

Group	Intervention	Description
Tissue Adhesive	Tissue Adhesive	Tissue Adhesive will be placed over subcuticular suture closure.
Steri-Strips	Sterile strips	Sterile strips will be placed over subcuticular suture closure.

Primary Outcome Measures

Name	Time	Method
Number of Participants With Wound Complication	6-8 weeks from cesarean delivery	Wound drainage, Cellulitis, Abscess, Hematoma, Seroma or Separation

Secondary Outcome Measures

Name	Time	Method
Number of Participants With Readmission for Wound Complication	Within 8 weeks from cesarean delivery
Satisfaction With Cesarean Scar	6-8 weeks from cesarean delivery	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.
Number of Participants Who Required an Office or Emergency Department Visit for Wound Complication	Within 8 weeks of delivery	The investigators will review medical records to assess for ambulatory visits for wound complaints
Operative Time	At time of delivery	The investigators will review operative records to assess operative time
Number of Participants Requiring Antibiotic Treatment for Wound Complication	Within 8 weeks of delivery	The investigators will review medical records to assess for antibiotic prescriptions for wound complications

Locations (3): NorthShore Highland Park Hospital
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Highland Park, Illinois, United States
University of Chicago
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Chicago, Illinois, United States
NorthShore Evanston Hospital
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Evanston, Illinois, United States