Grand Rounds

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

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

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

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

< Previous

Next >