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Background  This study assessed clinical outcomes, including safety and recurrence, from the two-year follow-up of patients who underwent open ventral primary hernia repair with the use of the Parietex™ Composite Ventral Patch (PCO-VP).    Methods  A prospective single-arm, multicenter study of 126 patients undergoing open ventral hernia repair for umbilical and epigastric hernias with the PCO-VP was performed.    Results  One hundred twenty-six subjects (110 with umbilical hernia and 16 with epigastric hernia) with a mean hernia diameter of 1.8 cm (0.4–4.0) were treated with PCO-VP. One hundred subjects completed the two-year study. Cumulative hernia recurrence was 3.0% (3/101; 95%CI: 0.0–6.3%) within 24 months. Median Numeric Rating Scale pain scores improved from 2 [0–10] at baseline to 0 [0–3] at 1 month ( P  < 0.001) and remained low at 24 months 0 [0–6] ( P  < 0.001). 99% (102/103) of the patients were satisfied with their repair at 24 months postoperative.    Conclusions  The use of PCO-VP to repair primary umbilical and epigastric defects yielded a low recurrence rate, low postoperative and chronic pain, and high satisfaction ratings, confirming that PCO-VP is effective for small ventral hernia repair in the two-year term after implantation.    Trial registration  The study was registered publically at clinicaltrials.gov ( NCT01848184  registered May 7, 2013).

Open ventral hernia repair with a composite ventral patch - final results of a multicenter prospective study