title: Coating of mesh grafts for prolapse and urinary incontinence repair with autologous plasma: exploration stage of a surgical innovation.
abstract: OBJECTIVE
  Optimized biocompatibility is a major requirement for alloplastic materials currently applied for stress urinary incontinence (SUI) and pelvic organ prolapse (POP) repair. In the preliminary studies the mesh modification by coating with autologous plasma resulted in the increased adherence score in vitro and improved biocompatibility in an animal model. The first use of plasma coated meshes in human is presented.
  
  
  METHODS
  Between 04/2013 and 05/2014, 20 patients with the indication for SUI and POP repair were selected in a single institution. The applied meshes were modified by autologous plasma coating prior to implantation. A retrospective chart review for peri- and early postoperative complications was performed. Functional outcome and QoL were evaluated pre- and postoperatively.
  
  
  RESULTS
  The functional outcome and QoL improved significantly in all groups. Two reoperations (Grade IIIB) with the release of TVT-mesh in anesthesia due to the obstruction were needed. No other severe complications were registered.
  
  
  CONCLUSIONS
  For the first time we applied a mesh modification in a human setting according to IDEAL criteria of surgical innovations. The procedure of mesh coating with autologous plasma is safe and a prospective randomized trial proving a positive effect of plasma coating on the biocompatibility and morbidity outcome with long-term registry is planned.
authors.affiliation: Department of Urology, Lukas Hospital, 41464 Neuss, Germany.
authors.forename: Dimitri
authors.identifier: 0000-0001-8611-8250
authors.initials: D
authors.lastname: Barski
authors.affiliation: Department of Urology, Lukas Hospital, 41464 Neuss, Germany ; German Centre for Assessment and Evaluation of Innovative Techniques in Medicine (DZITM), 41464 Neuss, Germany.
authors.forename: Holger
authors.identifier: 0000-0003-4160-8074
authors.initials: H
authors.lastname: Gerullis
authors.affiliation: Department of Urology, Lukas Hospital, 41464 Neuss, Germany.
authors.forename: Evangelos
authors.identifier: 0000-0003-2704-5164
authors.initials: E
authors.lastname: Georgas
authors.affiliation: Department of Surgery, Lukas Hospital, 41464 Neuss, Germany.
authors.forename: Andreas
authors.initials: A
authors.lastname: Bär
authors.affiliation: Department of Surgery, Lukas Hospital, 41464 Neuss, Germany.
authors.forename: Bernhard
authors.initials: B
authors.lastname: Lammers
authors.affiliation: ITERA (International Tissue Engineering Research Association), 2000 Antwerpen, Belgium.
authors.forename: Albert
authors.initials: A
authors.lastname: Ramon
authors.affiliation: Department of Surgery, University of Antwerpen, 2000 Antwerpen, Belgium.
authors.forename: Dirk
authors.initials: D
authors.lastname: Ysebaert
authors.affiliation: German Centre for Implant-Pathology, 52351 Düren, Germany.
authors.forename: Bernd
authors.initials: B
authors.lastname: Klosterhalfen
authors.affiliation: Department of Experimental Surgery, University of Szeged, H-6720 Szeged, Hungary.
authors.forename: Mihaly
authors.initials: M
authors.lastname: Boros
authors.affiliation: Department of Urology, Lukas Hospital, 41464 Neuss, Germany ; German Centre for Assessment and Evaluation of Innovative Techniques in Medicine (DZITM), 41464 Neuss, Germany.
authors.forename: Thomas
authors.initials: T
authors.lastname: Otto
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D064592:Autografts; D001696:Biomechanical Phenomena / Q000187:drug effects; D020099:Coated Materials, Biocompatible / Q000494:pharmacology*; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D056887:Pelvic Organ Prolapse / Q000601:surgery*; D010949:Plasma / Q000378:metabolism*; D011183:Postoperative Complications / Q000209:etiology; D013526:Surgical Mesh; D035703:Therapies, Investigational; D014550:Urinary Incontinence, Stress / Q000601:surgery*; D013520:Urologic Surgical Procedures / Q000379:methods*; D014945:Wound Healing / Q000187:drug effects*
chemical_list: D020099:Coated Materials, Biocompatible