title: 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.
authors.affiliation: School of Materials Science and Engineering, Shanghai Jiao Tong University, Shanghai, People's Republic of China; Shanghai Pine & Power Biotech Co. Ltd., Tongji University, Shanghai, People's Republic of China.
authors.forename: Xujun
authors.initials: X
authors.lastname: Wu
authors.affiliation: Department of Obstetrics and Gynecology, Shanghai Tongji Hospital, Tongji University, Shanghai, People's Republic of China.
authors.forename: Yuru
authors.initials: Y
authors.lastname: Wang
authors.affiliation: Shanghai Pine & Power Biotech Co. Ltd., Tongji University, Shanghai, People's Republic of China.
authors.forename: Cancan
authors.initials: C
authors.lastname: Zhu
authors.affiliation: Department of Obstetrics and Gynecology, Shanghai Tongji Hospital, Tongji University, Shanghai, People's Republic of China.
authors.forename: Xiaowen
authors.initials: X
authors.lastname: Tong
authors.affiliation: Shanghai Pine & Power Biotech Co. Ltd., Tongji University, Shanghai, People's Republic of China.
authors.forename: Ming
authors.initials: M
authors.lastname: Yang
authors.affiliation: Shanghai Pine & Power Biotech Co. Ltd., Tongji University, Shanghai, People's Republic of China.
authors.forename: Li
authors.initials: L
authors.lastname: Yang
authors.affiliation: School of Materials Science and Engineering, Shanghai Jiao Tong University, Shanghai, People's Republic of China; Shanghai Pine & Power Biotech Co. Ltd., Tongji University, Shanghai, People's Republic of China.
authors.forename: Zhang
authors.initials: Z
authors.lastname: Liu
authors.affiliation: Shanghai Pine & Power Biotech Co. Ltd., Tongji University, Shanghai, People's Republic of China.
authors.forename: Weihong
authors.initials: W
authors.lastname: Huang
authors.affiliation: Shanghai Pine & Power Biotech Co. Ltd., Tongji University, Shanghai, People's Republic of China.
authors.forename: Feng
authors.initials: F
authors.lastname: Wu
authors.affiliation: Shanghai Pine & Power Biotech Co. Ltd., Tongji University, Shanghai, People's Republic of China.
authors.forename: Honghai
authors.initials: H
authors.lastname: Zong
authors.affiliation: Department of Obstetrics and Gynecology, Shanghai Tongji Hospital, Tongji University, Shanghai, People's Republic of China.
authors.forename: Huaifang
authors.initials: H
authors.lastname: Li
authors.affiliation: Shanghai Pine & Power Biotech Co. Ltd., Tongji University, Shanghai, People's Republic of China; Section of Tissue Engineering, Institute of Peripheral Vascular Surgery, Fudan University, Shanghai, People's Republic of China.
authors.forename: Hongbing
authors.initials: H
authors.lastname: He
mesh_terms: D000818:Animals; D002986:Clinical Trials as Topic; D004285:Dogs; D005260:Female; D005340:Fibrinogen / Q000737:chemistry*; D006801:Humans; D017773:Pelvic Floor / Q000601:surgery*; D056887:Pelvic Organ Prolapse / Q000601:surgery*; D011091:Polyesters / Q000737:chemistry*; D019651:Plastic Surgery Procedures / Q000379:methods*; D013526:Surgical Mesh; D014621:Vagina / Q000473:pathology / Q000601:surgery
chemical_list: D011091:Polyesters; C550605:poly(lactic acid-co-epsilon-caprolactone); D005340:Fibrinogen
keywords: anterior pelvic floor reconstruction; fibrinogen; pelvic organ prolapse quantification; poly(l-lactide-co-caprolactone); polypropylene mesh