Demographics | Device group 20 (52.6%) | Control group 18 (47.4%) | P value |
Age, mean±SD | 46.3±24.6 | 56.8±20.2 | 0.1630 |
BMI, mean±SD | 28.2±5.6 | 26.4±5.0 | 0.3071 |
Male, n (%) | 17 (85.0) | 11 (61.1) | 0.1440 |
Trauma patient, n (%) | 12 (60.0) | 7 (38.9) | 0.1937 |
Penetrating injury, n (%) | 9 (75.0) | 3 (42.9) | 0.3261 |
Indication for the open abdomen* | |||
Anatomic reason, n (%) | 5 (25.0) | 3 (16.7) | 0.6968 |
Physiologic reason, n (%) | 15 (75.0) | 13 (72.2) | 1.000 |
Logistic reason, n (%) | 18 (90.0) | 12 (66.7) | 0.1171 |
Medical history | |||
Smoker, n (%) | 4 (20.0) | 4 (22.2) | 1.000 |
Previous laparotomy, n (%) | 1 (5.0) | 1 (5.6) | 0.941 |
Clinical status at the time of randomization | |||
Peritonitis/sepsis, n (%) | 5 (25.0) | 7 (38.9) | 0.3577 |
Ostomy, n (%) | 3 (15.0) | 1 (5.6) | 0.6062 |
Vasopressors, n (%) | 15 (75.0) | 11 (61.1) | 0.3577 |
Coagulopathy, n (%) | 8 (40.0) | 7 (38.9) | 0.9442 |
AKI, n (%) | 8 (40.0) | 4 (22.2) | 0.2391 |
APACHE II, mean±SD | 20.6±7.6 | 21.2±5.5 | 0.7591 |
Mannheim Peritonitis Index, mean±SD | 16.5±10.3 | 18.4±8.5 | 0.7130 |
*Some patients had more than one reason to leave the abdomen open, thus the number of indications is larger than the number of patients enrolled in the study.
AKI, acute kidney injury (twofold to threefold increase in serum creatinine and or urinary output <0.5 mL/kg for 12 hours); APACHE II, Acute Physiology and Chronic Health Evaluation II at admission to the intensive care unit after laparotomy; BMI, body mass index.