TABLE 3. Prespecified Secondary Efficacy and Safety Outcomes by Treatment Group.
Median (IQR) | |||
---|---|---|---|
Variable | ABThera (n = 23) | Barker's Vacuum Pack (n = 22) | P |
Efficacy outcomes | |||
Number of days alive and without the following condition or treatment within the first 30 d | |||
Open abdomen | 27 (0–28) | 18 (0–28) | 0.08 |
Mechanical ventilation | 18 (12–25) | 12 (0–26) | 0.12 |
Renal replacement therapy | 30 (19–30) | 24 (1–30) | 0.05 |
ICU stay | 17 (11–23) | 9 (0–23) | 0.10 |
Hospital stay | 0 (0–6) | 0 (0–11) | 0.43 |
Safety outcomes | |||
Enterocutaneous or enteroatmospheric fistula, n (%) | 2 (8.7) | 1 (4.6) | 0.52 |
Intra-abdominal pressure, mm Hg, median (IQR) | |||
0–24 hr (n = 33) | 16 (11–19) | 14 (11–17) | |
24–48 hr (n = 35) | 16 (12–19) | 16 (12–18) | |
48–72 hr (n = 8) | 15 (11–21) | 19 (18–20) | |
Grade III/IV intra-abdominal hypertension, n (%)* | |||
0–24 hr | 1/20 (5.0) | 0/13 (0) | >0.99 |
24–48 hr | 2/19 (10.5) | 1/16 (6.7) | >0.99 |
48–72 hr | 1/3 (33.3) | 1/5 (20.0) | >0.99 |
Recurrent abdominal compartment syndrome, n (%)† | 0 (0) | 0 (0) | NA |
*Defined as a mean daily value of intra-abdominal pressure of 21 mm Hg or more.
†Defined as an intra-abdominal pressure of more than 20 mm Hg with new onset organ failure in a patient with an open abdominal wound.
NA indicates not applicable.