Evaluation of Tissue Apposition and Seroma Prevention in an Ovine Model of Surgical Dead Space Using a Novel Air-Purged Vacuum Closure System.

Background: Postoperative complications associated with seroma formation resulting from surgical dead space continue to present a challenge in modern surgery. There is an unmet need for new technologies that address surgical dead space as well as prevent seroma formation and associated downstream postoperative complications. Methods: The novel implantable tissue apposition and drainage system ENIVO was developed and tested in a bilateral ovine external abdominal oblique (EAO) resection model of surgical dead space. The ENIVO system is a portable powered pump and wound interface featuring air-purged vacuum closure (APVC) that delivers a sustained level of vacuum pressure (80 and 100 mmHg) to the treatment site with an intermittent burst of sterile filtered air through the implanted wound interface. Seroma area, seroma volume, and drain migration were assessed at postoperative days 7 and 14, and all animals were euthanized at day 28 with gross assessment of treatment efficacy including the presence of residual seroma and tissue apposition. Results: The bilateral model created relatively uniform defects of ~120 cm Conclusions: The ENIVO system represents a new approach to dead space management and seroma prevention and was shown to outperform a SoC surgical drain in a challenging large defect model of surgical dead space management and seroma prevention.