Coating of Mesh Grafts for Prolapse and Urinary Incontinence Repair with Autologous Plasma: Exploration Stage of a Surgical Innovation

Abstract

Purpose. 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. Materials and 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. Conclusion. 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.

Protocol for a Randomized Phase II Trial for Mesh Optimization by Autologous Plasma Coating in Prolapse Repair: IDEAL Stage 3

“…Besides in vitro and in vivo data, the method has already proven feasible in a pilot study with 20 patients, thereby diminishing safety concerns [21]. In addition, our group has already developed and successfully implemented a long-term register for meshes and mesh modifications [22].…”

“…The current study protocol is based on the feasibility analysis of an already concluded successful pilot study with 20 patients [21]. Application of autologous blood plasma coating is performed according to the German Pharmaceutical Law (AMG), the Medical Product Act (MPG), and the Transfusion Act.…”

“…The underlying surgical technique is not altered by the application of our technology and the operation time will be increased by a maximum of 5 min as shown in a previous pilot study [21]. Figure 1 gives a simplified illustration of the two main steps of the procedure.…”

“…As a consequent next step this experimental approach of mesh coating with autologous plasma was transferred into human conditions where the procedure proved to be safe, feasible, and reproducible [21]. According to the assessment stage requirements a prospective randomized trial comparing the effect of plasma coating to non-coated meshes would be the next step in the development process.…”

Registry of implants for the reconstruction of pelvic floor in males and females: A feasibility case series

“…A retrospective study design was applied to evaluate the feasibility of the registry. Different mesh materials were used (TVT ® , Seratim ® , Ultrapro ® , Vitamesh ® ) and were all modified by a new technique with preoperative surface coating with autologous plasma [12]. The technique has been evaluated previously in accordance with preclinical IDEAL stage 0 [13].…”