Reconstruction of abdominal wall with scaffolds of electrospun poly (l-lactide-co caprolactone) and porcine fibrinogen: An experimental study in the canine.

BACKGROUND: The use of permanent synthetic materials for abdominal wall repair is currently the method of choice. However, they are not ideal as short-term and long-term complications have been reported for these materials including chronic groin pain (pain that lasted longer than 3 months), which occurred in 10-12% of patients, and host immunological responses to foreign body grafts. In the present randomized paired study we compared an electrospun composite scaffold composed of poly (l-lactide-co-caprolactone) [PLCL] blended with porcine fibrinogen (F-Fg) (PLCL/F-Fg), with a polypropylene mesh (PPM) as the control in a canine abdominal wall defect model (in 36 Beagle dogs). RESULTS: A blend ratio of 4:1 PLCL: F-Fg1 scaffold possessed optimal physical characteristics including shrinkage rate, mechanical strength, porosity and super-hydrophilic properties. Macroscopic, histological and biomechanical evaluations were performed over a period of 36 weeks and the results indicated that the resorbable PLCL/F-Fg1 electrospinning scaffold could effectively induce and augment abdominal skeletal muscle regeneration. The degradation rate of the PLCL/F-Fg1 scaffold and the rate of new tissue growth reached a balance and the biomechanical strength returned to baseline within 2 weeks of implantation. The immunohistological data demonstrated the presence of regenerated skeletal muscle tissue for PLCL/F-Fg1 scaffolds, whereas the PPM exhibited dense fibrous encapsulation along the perimeter of the mesh. CONCLUSIONS: The data provides the foundation for future clinical applications of PLCL/F-Fg1 composite scaffolds for reconstructive surgery of abdominal wall defects.

Electrospun P(LLA-CL) Nanoscale Fibrinogen Patch vs Porcine Small Intestine Submucosa Graft Repair of Inguinal Hernia in Adults: A Randomized, Single-Blind, Controlled, Multicenter, Noninferiority Trial.

BACKGROUND: The aim of this study was to compare primary efficacy indicators of a low-cost, electrospun, nanoscale P(LLA-CL)/fibrinogen patch with a porcine small intestine submucosa patch for hernia repair. STUDY DESIGN: A randomized, single-blind, controlled multicenter trial was performed in 3 hospitals in Shanghai. Eligible patients (20 to 75 years old) with primary unilateral, reducible groin hernias were randomly assigned (1:1) to electrospun nanoscale P(LLA-CL)/fibrinogen patch (experimental group) or porcine small intestine submucosa (control group) patch groups. Patients were treated with the Lichtenstein technique, and the primary endpoint was hernia recurrence at 33 months after surgery. The secondary endpoints were postoperative complications including groin pain and operative site infections. RESULTS: Between July 2014 and February 2016, 172 patients were assigned to experimental (n = 86) and control (n = 86) groups. At 6-month follow-up, postoperative complications occurred in 5 patients (5 of 86, 5.81%) and 2 (2 of 86, 2.35%) patients in the control and experimental groups, respectively (p < 0.05). At 33-month follow-up, recurrence was observed in 2 patients (2 of 79, 2.53%) in the control group vs none in the experimental group (0 of 78) (the 95% CI difference between the experimental and control groups was -0.93% to 6.00% and within the preset noninferior margin of Δ10%). No significant differences were found in the degree of chronic pain and complications 33 months after surgery between the 2 groups. CONCLUSIONS: Because the recurrence rates and postoperative complications after 33 months were not inferior in the experimental group, we believe that the P(LLA-CL)/fibrinogen patch, as a low cost alternative, has prospects for widespread clinical use.