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Tissue Adhesive Compared With Sterile Strips After Cesarean Delivery

A Randomized Controlled Trial

Braginsky, Lena MD; Javellana, Melissa MD; Cleveland, Emily BA, BS; Elue, Rita MPH, FNP-BC; Wang, Chi PHD; Boyle, Deborah MD; Plunkett, Beth A. MD, MPH

doi: 10.1097/AOG.0000000000003367
Contents: Obstetrics: Original Research
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OBJECTIVE: To assess whether tissue adhesive after closure of Pfannenstiel incision for cesarean delivery lowers the risk of wound complications when compared with sterile strips.

METHODS: In this multicenter randomized controlled trial, women undergoing cesarean delivery using Pfannenstiel skin incision were randomized to receive tissue adhesive (2-octyl cyanoacrylate) compared with sterile strips after closure of the skin incision. The primary outcome was a composite of wound complications (drainage, cellulitis, abscess, seroma, hematoma, or isolated wound separation) within 8 weeks of delivery. Secondary outcomes included operative time, readmission, office or emergency department visits, or antibiotic use for wound complications, and patient satisfaction with the cesarean scar. With 80% power and a 95% CI, a sample size of 432 per group (n=864) was required to detect a 50% reduction in the primary outcome. A planned interim analysis was performed after 500 patients delivered. A conditional power analysis revealed that the probability of showing a benefit with tissue adhesive was extremely low (6.2%), and the study was halted owing to futility.

RESULTS: Between November 2016 and April 2018, 504 patients were randomized, and follow-up was achieved in 479 (95%). Wound complications occurred in 18 out of 238 patients (7.6%) in the tissue adhesive group and 19 out of 241 patients (7.9%) in the sterile strips group (relative risk 0.96; 95% CI 0.51–1.78). There were no significant differences with regard to types of wound complications, operative time, readmission, office or emergency department visits, antibiotics prescribed for wound complications, or patient scar assessment scores of pain, stiffness, and irregularity between the two groups. However, tissue adhesive performed slightly better in regard to itchiness of scar and overall scar satisfaction.

CONCLUSION: Compared with sterile strips, tissue adhesive after closure of Pfannenstiel incision for cesarean delivery is unlikely to lower the risk of wound complications.

CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov, NCT02838017.

Compared with sterile strips, tissue adhesive after closure of Pfannenstiel incision for cesarean delivery is unlikely to lower the risk of wound complications.

Departments of Obstetrics and Gynecology and Biostatistics and Research Informatics, NorthShore University HealthSystem, Evanston, and the Department of Obstetrics and Gynecology, University of Chicago, Chicago, Illinois.

Corresponding author: Lena Braginsky, MD, NorthShore University HealthSystem, Evanston, IL; email: Lena.Braginsky.MFM@gmail.com.

Supported by the Chicago Lying-in Hospital Women's Board Maternal-Fetal Medicine Fellowship Award.

Financial Disclosure The authors did not report any potential conflicts of interest.

Presented at the 39th annual meeting of the Society for Maternal-Fetal Medicine, February 11–16, 2019, Las Vegas, Nevada.

Each author has confirmed compliance with the journal's requirements for authorship.

Peer reviews and author correspondence are available at http://links.lww.com/AOG/B448.

© 2019 by the American College of Obstetricians and Gynecologists. Published by Wolters Kluwer Health, Inc. All rights reserved.