Outcomes of a prospective multi-center trial of a second-generation composite mesh for open ventral hernia repair.

PURPOSE: Composite mesh prostheses incorporate properties of multiple materials for use in open ventral hernia repair (OVHR). This study examines clinical outcomes in patients who underwent OVHR with a polypropylene/expanded polytetrafluoroethylene (ePTFE) composite graft containing a novel polydioxanone (PDO) absorbable ring to facilitate placement and graft positioning. METHODS: Data were prospectively collected on consecutive patients undergoing OVHR using a synthetic composite mesh. Seven centers enrolled patients during the study period. All patients underwent a standardized surgical procedure consisting of OVHR with sublay intraperitoneal placement of mesh. Mesh fixation was accomplished with peripheral tacks and transfascial sutures. RESULTS: One hundred and nineteen patients underwent OVHR with the composite mesh. Average age was 55.8 years; there were 71 (59.7 %) females and 48 (40.3 %) males with mean BMI of 33.5 ± 7.1 kg/m(2). One hundred and two (85.7 %) patients presented with primary ventral hernias. Mean defect size was 13.6 cm(2), and mean mesh size was 113.6 cm(2). Most patients (67 %) were discharged the day of surgery. Twelve patients (10.1 %) experienced complications in the perioperative time period primarily consisting of seroma (4.2 %) and ileus (1.7 %). Two patients required reoperation and mesh removal in the early postoperative period for infection and herniorrhaphy site pain, respectively. There was a decline in pain and movement limitation scores between baseline and 1-year follow-up. Six-month (n = 109) and twelve-month (n = 99) follow-up revealed no hernia recurrences (95 % CI 0-3 %, and 0-4 %, respectively). CONCLUSIONS: The use of this second-generation composite mesh was associated with no hernia recurrences and a low complication rate after open ventral hernia repair.

Evaluation of absorbable and permanent mesh fixation devices: adhesion formation and mechanical strength.

PURPOSE: Laparoscopic ventral hernia repair is commonly performed with mesh prostheses; however, there is no standard for fixation devices used to secure mesh to the abdominal wall. This study is a functional comparison of novel, screw-type absorbable and permanent fixation devices with a traditional titanium fixation device. METHODS: Fifteen pigs each underwent the laparoscopic placement of two 11 × 14-cm mesh prostheses and were randomized for mesh fixation with either titanium spiral tacks (TS), absorbable screw-type fasteners (SF), or permanent screw-type fasteners (PF) (n = 10 mesh prostheses for each fixation group). Adhesions were assessed laparoscopically at 4 weeks. The fixation devices were also embedded in porcine abdominal rectus muscle for ex vivo mechanical testing along with partial thickness polypropylene suture (PR) as a control group (n = 40 for each group). Maximum pull-off forces were measured. All statistical tests were two-tailed, and a P-value < 0.05 was considered to be significant. RESULTS: The mean tenacity adhesion scores were 1.40 ± 0.52 (PF), 1.7 ± 0.82 (SF), and 2.6 ± 1.07 (TS). Adhesions in the PF group were significantly less tenacious compared with the TS group (P = 0.01). Quantitative adhesion scores were not significantly different among groups. The maximum pull-off forces, measured in Newtons, were 28.61 N ± 4.89 N (TS), 22.71 N ± 7.86 N (SF), 16.98 N ± 7.59 N (PF), and 20.83 N ± 6.25 N (PR). The pull-off force in the TS group was higher than all of the other groups (P < 0.001). The SF group also had a higher pull-off force compared with the PF group (P < 0.001). CONCLUSIONS: The screw-type absorbable and permanent fixation devices provided adequate fixation and were associated with decreased adhesions in this porcine model.