Expanded polytetrafluoroethylene patch versus braided polyester tape for the repair of incompetent cervix

BACKGROUND: This study was done to evaluate pregnant patients with cervical incompetence using an expanded polytetrafluoroethylene (ePTFE) patch versus the commonly used braided polyester tape, comparing the rate of local tissue reaction or onset of contractions, or both. STUDY DESIGN: This study was a prospective clinical trial on 20 patients divided into two groups. Patients having tissue reactions or contractions were identified and each material was analyzed using a new approach by means of scanning electron microscopy (SEM) and roentgenogram diffraction studies. RESULTS: In the group of pregnant patients sutured with polyester tape there were four failures because of infection and contractions. There were no direct or indirect complications encountered in the ePTFE group. Bacteriologic evaluations of the failures revealed Escherichia coli, Gardnerella vaginalis, Bacteroides species, and Trichomonas vaginalis in various combinations, in addition to crystal structure degradation and layers of phagocytes. CONCLUSIONS: Our results provide a rationale for understanding the differences in morphologic integrity and the superiority of the ePTFE patch over the polyester tape using a new analytic approach of SEM and roentgenographic diffraction studies. Because of the small number of patients and because the procedure was performed in a select patient population, we recommend that further trials be undertaken with a larger number of patients in more advanced gestational age and in patients presenting with emergent cervical incompetence.