New non-invasive device to promote primary closure of the fascia and prevent loss of domain in the open abdomen: a pilot study.

ABSTRACT

BACKGROUND: Primary closure of the fascia at the conclusion of a stage laparotomy can be a challenging task. Current techniques to medialize the fascial edges in open abdomens entail several trips to the operating room and could result in fascial damage. We conducted a pilot study to investigate a novel non-invasive device for gradual reapproximation of the abdominal wall fascia in the open abdomen. METHODS: Mechanically ventilated patients ≥16 years of age with the abdominal fascia deliberately left open after a midline laparotomy for trauma and acute care surgery were randomized into two groups. Control group patients underwent standard care with negative pressure therapy only. Device group patients were treated with negative pressure therapy in conjunction with the new device for fascial reapproximation. Exclusion criteria pregnancy, traumatic hernias, pre-existing ventral hernias, burns, and body mass index ≥40 kg/m2. The primary outcome was successful fascial closure by direct suture of the fascia without mesh or component separation. Secondary outcomes were abdominal wall complications. RESULTS: Thirty-eight patients were investigated, 20 in the device group and 18 in the control group. Primary closure of the fascia by direct suture without mesh or component separation was achieved in 17 patients (85%) in the device group and only 10 patients (55.6%) in the control group (p=0.0457). Device group patients were 53% more likely to experience primary fascial closure by direct suture than control group patients. Device group showed gradual reduction (p<0.005) in the size of the fascial defects; not seen in control group. There were no complications related to the device. CONCLUSIONS: The new device applied externally on the abdominal wall promoted reapproximation of the fascia in the midline, preserved the integrity of the fascia, and improved primary fascial closure rate compared with negative pressure therapy system only. LEVEL OF EVIDENCE I, randomized controlled trial.