Does Tissue Adhesive Decrease Cesarean Wound Infection?

BACKGROUND AND PURPOSE:

  • A tissue adhesive using 2-octyl cyanoacrylate inhibits bacterial growth for up to 10 days and appears to have bactericidal qualities
  • Braginsky et al. (Obstetrics & Gynecology, 2019) compared risk of wound infection following use of tissue adhesive vs sterile strips for Pfannenstiel incision closure at cesarean section

METHODS:

  • Multicenter randomized controlled trial (RCT)
  • Participants
    • Cesarean delivery
    • Pfannenstiel skin incision
  • Infection prophylaxis best practices including
    • Chlorhexidine skin prep | Pre-op antibiotics before skink incision | suture if subQ >2cm | skin closed with subcuticular
  • Groups (randomized)
    • Tissue adhesive (2-octyl cyanoacrylate)
    • Sterile strips
  • Primary outcome: A composite of wound complications
    • Drainage | Cellulitis | Abscess | Seroma | Hematoma | Isolated wound separation
    • Occurring within 8 weeks of delivery
  • Secondary outcomes
    • Operative time
    • Readmission
    • Office or emergency department visits
    • Antibiotic use for wound complications
    • Patient satisfaction with the cesarean scar
  • Statistical analysis
    • 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
    • Planned interim analysis was performed after 500 patients

RESULTS:

  • At interim analysis point in the study
    • Tissue adhesive group: 238 | Sterile strips group: 241
  • Wound complications
    • Tissue adhesive group: 7.5%
    • Sterile strips group: 7.9%
    • Relative risk: 0.96 (95% CI, 0.51 to 1.78)
  • There were no significant differences identified for the following
    • Types of wound complications
    • Operative time
    • Readmission or office or emergency department visits
    • Antibiotics prescribed for wound complications
    • Patient scar assessment scores of pain, stiffness, and irregularity
  • Tissue adhesive performed slightly better in regard to itchiness of scar and overall scar satisfaction
  • Based on above data at interim analysis, using conditional power analysis
    • Probability of showing a benefit with tissue adhesive was extremely low (6.2%)
    • Study was halted due to futility

CONCLUSION:

  • Authors suggest that the reason tissue adhesive may work better to prevent infection in non-OB cases is that while it may be effective against skin microbes, it may not work as well against microorganisms arising from the genital tract
  • Limitations include the fact that the trial was unmasked and the incidence of wound complication was lower than anticipated (7.7% vs 10%)
  • Tissue adhesive with 2-octyl cyanoacrylate is unlikely to reduce risk of wound complications when used to close a cesarean Pfannenstiel incision

Learn More – Primary Sources:

Tissue Adhesive Compared With Sterile Strips After Cesarean Delivery – A Randomized Controlled Trial