5 (3–25) · ISS 25 (9–50) · NISS 33 (13–66) IAP (# patients) · <12 mmHg 10 · >12 mmHg (IAH) 10 IAP = intra-abdominal pressure; IAH = intra-abdominal hypertension as defined by Torin 1 order Cheatham et al. 2007 [9]. Primary objective – fascial closure rate Fascial closure was achieved in 13 out of 20 patients (65% of patients on an intent-to-treat basis) (see Table 3; see supplemental data for Kaplan-Meier estimate data). Fascial closure rate expressed as the percentage of survivors was 75% (12/16 patients) (data not shown). One patient died following fascial closure but the remaining 12
closed abdomens were stable at a follow up 8 days after closure although a superficial wound sepsis was present in one. The median time to achieve primary fascial closure was 3 days (CI) (n=20). Two patients were withdrawn from the study after 19 and 24 days of NPWT therapy because they developed a Grade 4 (fixed) abdomen and fascial closure was no longer an option (i.e. LOXO-101 solubility dmso they could no longer contribute to the primary objective). Each open abdomen was graded according to the WSACS classification [7] (Table 1) at the initial application of NPWT and at each subsequent dressing
change, including the final removal of the dressing. The grade of open abdomen for the majority of patients improved during the course of therapy. Table 3 Progression of open abdominal wounds from initial presentation to end CYTH4 of therapy Grade Baseline End of therapy Closed 0 13 (65%) 1a 14 (70.0%) 2 (10%) 1b 5 (25.0%) 1 (5%) 2 1 (5.0%) 2 (10%) 2c 0 0 3 0 0 4 0 2 (10%) N 20 (100%) 20 (100%)* Progress of the wounds during therapy was assessed using the Bjorck et al. classification system. *one patient died less than 24 hours after having a baseline assessment. As no other data was available, it was assumed that the wound grade at death was the same as the baseline assessment (Grade 1A). Secondary objectives SOFA and APACHE11 scores decreased from medians of 11 and 14.5 at baseline to 9 and 12 respectively at the end of
therapy. There was no apparent relationship between IAP at baseline and achievement of fascial closure. Median time in ICU was 8 days (range 1–28 days, n=20). In the remaining patients, reasons for discontinuation of NPWT were death, (3/20; 15%), poor compliance (1/20; 5%), withdrawal for other reasons (1/20; 5% – persistent bowel find more hematic as a consequence of an extremely large viscera). Fluid contained in the waste canister was approximately measured and this formed part of the daily fluid management of the patient. A mean volume of 871 ml (median 700 ml) was present in the canister at dressing change. Blood loss into the canister was also an early sign of internal bleeding and allowed rapid intervention (data not shown). A range of complications were assessed and results are shown in Table 4. One fistula (5%) was observed during the study in a single patient who had received penetrating trauma.