Table 4. Systematic review results on secondary endpoints.
| RCT | Endpoint | NPWT | Control | p value | Remarks |
| Commercially available systems | |||||
| Blume 2008 (8) | No. of days to complete wound closure; median (95% CI) | 96 (75 to 114) | >112 | p = 0.001 | Results based on Kaplan–Meier analysis |
| Blume 2008 (8) | Reduction in wound surface area (cm2) | – 4.3 | – 2.5 | p = 0.021 | Measured 28 days after beginning of treatment |
| Blume 2008 (8) | Secondary amputations; n (%) | 7 (4) | 17 (10) | p = 0.035 | – |
| Blume 2008 (8) | Mortality; n (%) | 3 (2) | 3 (2) | n/a | – |
| Blume 2008 (8) | No. of wound complications (edema, infection of wound, cellulitis, osteomyelitis); n (%) | 16 (10) | 11 (7) | – | No statistically significant difference in any individual adverse event |
| Chio 2010 (9) | No. of wound complications; n (%) | 7 (30) | 12 (44) | p = 0.816 | However, according to Table 2 of article NPWT 35% (8 of 23), not 30% (7 of 23) as stated in text |
| Keskin 2008 (10) | Increase in STAI; mean (SD) | 14.0 (2.3) | 2.6 (1.2) | p < 0.001 | Increase in fear during the first 10 days of treatment |
| Keskin 2008 (10) | Increase in HAM; mean (SD) | 4.4 (0.6) | 1.3 (0.6) | p < 0.001 | Increase in fear during the first 10 days of treatment |
| Stannard 2009 (11) | Wound complications: rate of deep wound infections; n (%) | 2 (5) | 7 (28) | p = 0.024 | – |
| Stannard 2009 (11) | Physical quality of life according to SF-36 after 6 months; mean (95% CI) | 43 (35 to 50) | 34 (29 to 39) | p = 0.049 | Results after 3 and 9 months also showed a statistically significant benefit for NPWT. |
| Stannard 2009 (11) | Mental quality of life according to SF-36 after 6 months; mean (95% CI) | n/a | n/a | n/a | Results after 3, 6, and 9 months all failed to show any statistically significant difference. |
| Systems not commercially available | |||||
| Bee 2008 (12) | Mortality; n (%) | 7 (26) | 5 (25) | n/a | 3 patients died within 7 days and were excluded from analysis. NPWT failed in a further 2 patients, who were successfully treated using the control therapy. |
| Bee 2008 (12) | Intestinal fistula formation; n (%) | (21) | (5) | p = 0.14 | – |
| Bee 2008 (12) | Abdominal abscess; n (%) | 12 (44) | 9 (47) | n/a | – |
| Mody 2008 (13) | Days to complete wound closure; mean (SD) | 36 (45) | 28 (19) | p = 0.66 | – |
| Mody 2008 (13) | No. of wound complications; n (%) | 6 (32) | 2 (6) | n/a | – |
| Perez 2010 (14) | Days to complete wound closure; mean (R) | 16 (14 to 23) | 25 (23 to 32) | p = 0.013 | – |
| Perez 2010 (14) | Secondary surgery rate | 7 | 4 | p = 0.038 | – |
| Saaiq 2010 (15) | 95% acceptance of skin transplant; n (%) | 45 (90) | 9 (18) | p < 0.001 | No patient characteristics reported for either treatment group. Categories from 1 to 3 given for endpoints. |
| Saaiq 2010 (15) | Mortality; n (%) | 0 | 0 | n/a | – |
| Saaiq 2010 (15) | No. of patients with complete wound closure within 2 weeks; n (%) | 45 (90) | 9 (18) | p < 0.001 | – |
| Saaiq 2010 (15) | No. of cases needing repeat skin transplantation: n (%) | 0 | 4 (8) | n/a | – |
| Sepúlveda 2009 (16) | Hospital mortality; n (%) | 0 | 0 | n/a | – |
| Sepúlveda 2009 (16) | Days to 90% wound granulation; mean (SD) | 19 (6) | 32 (14) | p = 0.007 | – |
RCT: Randomized controlled trial; –: not applicable; HAM: Hamilton Rating Scale; CI: Confidence interval; SF 36: short form (36) health survey; n/a: not available; NPWT: negative-pressure wound therapy; STAI: State-Trait Anxiety Inventory; R: range; SD: standard deviation