A multicenter prospective trial evaluating fetal bovine dermal graft (Xenform® Matrix) for pelvic reconstructive surgery

Howard B Goldstein,Joseph Maccarone,Oscar A Aguirre,Rakesh C Patel,Martin J Naughton

doi:10.1186/1471-2490-10-21

Howard B Goldstein, Joseph Maccarone + Show 3 more

Open Access

https://doi.org/10.1186/1471-2490-10-21

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Abstract

BackgroundA prospective multicenter clinical study was performed to evaluate the safety and efficacy of a bovine dermal graft (Xenform® Matrix, Boston Scientific, Natick, MA, USA) during vaginal reconstructive surgery.MethodsForty-five women with ICS stage 2 or higher pelvic organ prolapse (POP) were enrolled at 4 centers. POP-Q, pelvic floor function (PFDI-20), sexual function (PISQ-12), and patient satisfaction tools were used to assess subjects at baseline, and at 2 and 6 weeks, and 3, 6 and 12 months post surgery. The significance of symptom score changes at 6 months and 1 year were determined by the t-test for paired data. Forty-three of the 45 patients completed the 12 month study.ResultsThe majority of the subjects had cystocele (98%) and/or rectocele (84%) defects at study entry. At 12 months, 74% of the defects had improved to a stage 0 or 1. Mean PFDI-20 scores improved by 72% (p < 0.001) at 12 months, and PISQ-12 scores were maintained during the follow-up period indicating no decline in sexual function. Three subjects experienced one serious adverse event each; one of the adverse events (constipation) was deemed by the study physician to be unrelated to Xenform®. One subject had severe pyelonephritis resulting in dialysis. This subject had a previous history of pyelonephritis, sepsis and acute renal failure. The third subject had a reported recurrent cystocele of moderate severity, possibly related to the device. No graft related erosions or pain lasting more than 30 days were reported. No subjects withdrew due to an adverse event.ConclusionThis study is the first to investigate the use of Xenform® Matrix in vaginal reconstructive surgery among patients with POP. Significant improvement was maintained at 12 months utilizing both objective and subjective assessment tools, confirming the safety and efficacy of this material in vaginal surgery.Trial RegistrationClinicalTrials.gov NCT01244165

Highlights

A prospective multicenter clinical study was performed to evaluate the safety and efficacy of a bovine dermal graft (Xenform® Matrix, Boston Scientific, Natick, MA, USA) during vaginal reconstructive surgery
One subject had severe pyelonephritis resulting in dialysis
This subject had a previous history of pyelonephritis, sepsis, and acute renal failure

Summary

Introduction

A prospective multicenter clinical study was performed to evaluate the safety and efficacy of a bovine dermal graft (Xenform® Matrix, Boston Scientific, Natick, MA, USA) during vaginal reconstructive surgery. Graft materials have long been used as adjuncts, with excellent efficacy and safety, and their use may be extended into anterior and posterior vaginal repairs. In this way, grafts are being used to reinforce repairs, or to replace the supportive tissue that is either deficient or absent [3]. Grafts are being used to reinforce repairs, or to replace the supportive tissue that is either deficient or absent [3] Depending on their placement, grafts can correct both central and lateral anterior vaginal wall defects, as well as those involving the rectovaginal septum

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