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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 cm2 following excision of ~30 to 50 g of EAO muscle. Median seroma area of ENIVO-treated defects was statistically smaller than standard of care (SoC)-treated defects at days 7 and 14. Median seroma volume at 14 days was significantly reduced in ENIVO-treated defects relative to SoC-treated defects [1.3 (IQR 0.0-79.5) mL and 188.5 (IQR 27.6-342.9) mL, respectively]. At postoperative day 28, 40% (n = 4/10) of SoC defects showed a residual seroma, whereas in contrast, none of the ENIVO-treated defects showed signs of a residual seroma. Median tissue apposition scoring was higher in the ENIVO treatment group [3 (IQR 3-3)] compared with the SoC group [3 (IQR 0-3)].


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.