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

Related ObG Topics: