Randomized treatment arm | NPWT | CWT | ||
---|---|---|---|---|
Study participants with inpatient study start, No. (%)* | 144 of 157 (91.7) | 155 of 174 (89.1) | ||
Study participants treated exclusively inpatient, No. (%)* | 17 of 144 (11.8) | 7 of 155 (4.5) | ||
Study participants with surgical wound closure before first hospital discharge, No. (%) | 36 of 144 (25.0) | 17 of 155 (11.0) | ||
Study participants with hospital discharge, No. (%)* | 127 of 144 (88.2) | 148 of 155 (95.5) | ||
Study participants with completed treatment before first hospital discharge (including those with wound closure), No. (%) | 46 of 144 (1.9) | 26 of 155 (16.8) | ||
Study participants with completed treatment before first hospital discharge and complete, verified and sustained wound closure within 42 days, No. (%) | 40 of 46 (87.0) | 21 of 26 (80.8) | ||
Time to complete, sustained and verified wound closure (days) within 42 days for study participants with completed treatment before first hospital discharge, Mean (SE) [95% CI] | 26.3 (1.0) [24.2–28.3] | 29.9 (1.5) [26.8–33.0] | ||
Study participants under treatment at first hospital discharge, No. (%)* | 81 of 144 (56.3) | 122 of 155 (78.7) | ||
Study participants with treatment termination at day of first hospital discharge, No. (%)* | 0 | 1 | ||
Treatment status at first hospital discharge and continuation of the respective treatment during outpatient care in the PP population | NPWT | CWT after NPWT | NPWT | CWT |
Study participants in the outpatient subpopulation, No. (%) | 55 of 157 (35.0) | 26 of 157 (16.6) | 0 of 174 (0) | 121 of 174 (69.5) |
Total treatment time until complete, sustained and verified wound closure or end of study treatment time after 42 days, Mean (SD) [Min–Max] | 25.2 (13.1) [6–42] | 34.3 (9.2) [16–42] | NA | 34.4 (11.1) [7–42] |
Outpatient treatment time until complete, sustained and verified wound closure or end of study treatment time after 42 days, Mean (SD) [Min–Max] | 17.1 (11.5) [0–39] | 16.1 (9.8) [1–33] | NA | 23.1 (11.7) [0–40] |
Study participants with rehospitalization, No. (%) | 8 of 55 (14.5%) | 6 of 26 (23.1%) | NA | 13 of 121 (10.7%) |
Study participants with complete, verified and sustained wound closure within 42 days, No. (%) | 27 of 55 (49.1) | 8 of 26 (30.8) | NA | 27 of 121 (22.3) |
Time to complete, sustained and verified wound closure (days) within 42 days, Mean (SE) [95% CI] | 28.8 (8.0) [25.6–32.0] | 28.9 (9.5) [20.9–36.8] | NA | 30.4 (8.0) [27.3–33.6] |
Study participants still under treatment at day 42, No. (%) | 7 of 157 (4.5%) | 38 of 157 (24.2%) | NA | 85 of 174 (48.9%) |
Study participants still under treatment in hospital at day 42, No. (%) | 2 of 7 (28.6%) | 6 of 38 (15.8%) | NA | 8 of 85 (9.4%) |
Study participants still under treatment in outpatient care at day 42 No. (%) | 5 of 7 (71.4%) | 32 of 38 (84.2%) | NA | 77 of 85 (90.6%) |
Study participants with wound closure within 132 days, No. (%) | 47 of 55 (85.5) | 21 of 26 (80.8) | NA | 98 of 121 (81.0) |
Time to wound closure (days) within 132 days, Mean (SE) [95% CI] | 42.4 (3.3) [35.8–48.9] | 54.7 (7.0) [40.2–69.3] | NA | 56.3 (2.6) [51.1–61.5] |