Preclinical animal study and human clinical trial data of co-electrospun poly(l-lactide-co-caprolactone) and fibrinogen mesh for anterior pelvic floor reconstruction

Abstract

Synthetic and biological materials are commonly used for pelvic floor reconstruction. In this study, host tissue response and biomechanical properties of mesh fabricated from co-electrospun poly(l-lactide-co-caprolactone) (PLCL) and fibrinogen (Fg) were compared with those of polypropylene mesh (PPM) in a canine abdominal defect model. Macroscopic, microscopic, histological, and biomechanical evaluations were performed over a 24-week period. The results showed that PLCL/Fg mesh had similar host tissue responses but better initial vascularization and graft site tissue organization than PPM. The efficacy of the PLCL/Fg mesh was further examined in human pelvic floor reconstruction. Operation time, intraoperative blood loss, and pelvic organ prolapse quantification during 6-month follow-up were compared for patients receiving PLCL/Fg mesh versus PPM. According to the pelvic organ prolapse quantification scores, the anterior vaginal wall 3 cm proximal to the hymen point (Aa point), most distal edge of the cervix or vaginal cuff scar point (C point), and posterior fornix point (D point) showed significant improvement (P<0.01) at 1, 3, and 6 months for both groups compared with preoperatively. At 6 months, improvements at the Aa point in the PLCL/Fg group were significantly more (P<0.005) than the PPM group, indicating that, while both materials improve the patient symptoms, PLCL/Fg mesh resulted in more obvious improvement.

Keywords:

• anterior pelvic floor reconstruction
• polypropylene mesh
• poly(l-lactide-co-caprolactone)
• fibrinogen
• pelvic organ prolapse quantification

Disclosure

No financial support or benefits have been received by XJW, YRW, XWT, and HFL from any commercial source that is related directly or indirectly to the scientific work reported on in the paper, except as described as follows. HBH is one of the founders and stockholders of P&P Biotech Co., Ltd; CCZ, MY, ZL, WHH, FW, and HHZ are employed by Shanghai Pine & Power Biotech Co., Ltd. (Shanghai, People’s Republic of China) who provided support for research activities, writing, and editing of the paper, but otherwise played no role in the study design or implementation. The authors report no other conflicts of interest in this work.