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P028: SURGICAL SITE INFECTIONS AND OCCURRENCES (SSIS & SSOS) AFTER VENTRAL HERNIA REPAIR (VHR) WITH REINFORCED TISSUE MATRIX (RTM), 30-DAY DATA FROM THE BRAVO STUDY.
George DeNoto, MD, FACS; St. Francis Hospital
Purpose: To report 30 days post-op results in 85 patients enrolled in the BRAVO clinical trial. For hospitals and surgeons, adverse events and complications that occur in the first 30 days are of special significance as costs of treatment of these events must be borne by the hospital, and these complications are recorded on the surgeon’s score card.
Methods: BRAVO is a prospective, single-arm, multicenter study evaluating SSIs, SSOs, hernia recurrence and patient satisfaction over 24 months with OviTex RTM. Procedures were performed open and minimally invasively. Any deviation from an uncomplicated post-operative course, however small, was considered an adverse event (AE). A subset was characterized as either SSI or SSO if they met the published definitions.
Results: Eighty-five (85) patients were enrolled and evaluated at 30 days post-op. There were 51 women and 34 men with an average age of 62.0 years. Over half were (morbidly) obese, over one third had undergone a previous repair and one in five had a history of surgical infections. Over half the patients met the criteria for Ventral Hernia Working Group (VHWG) grade 2, the remaining patients were equally divided between VHWG grades 1 and 2. In total 41 patients had one or more AEs. There were 11 SSOs and 9 SSIs. Of those, 4 SSOs and 6 SSIs required a procedural intervention (PI). These included percutaneous drainage, wound debridement and negative wound pressure therapy. There were no surgical interventions or implant removals.
Conclusion: The combined observed incidence of 12% for SSIs and SSOs requiring a PI at 30 days, as well as the nature of the PIs, confirm that OviTex RTMs are suitable to reinforce VHRs in a variety of patients. All subjects continue to be followed for 24 months.
*On behalf of the BRAVO Study Group
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