Niezgoda 2004.
Study characteristics | ||
Methods | 2‐arm RCT Conducted in USA Follow‐up (at time results presented) 42 days (6 weeks) |
|
Participants | 97 participants. Inclusion criteria listed: stage III and IV pressure ulcers located on the trunk or trochanter regions Exclusion criteria listed: none listed |
|
Interventions | Group A: NPWT (VAC) n = 54 Group B: moist wound healing (no further information) n = 43 |
|
Outcomes | Primary outcomes: none Secondary outcomes: Change in ulcer size (unadjusted) Cost |
|
Notes | Conference abstract; interim analyses; abstract notes that full follow‐up was planned as 82 days Authors contacted via e‐mail and confirmed that the full study was not published and that outcome data were not available to us Funding not reported |
|
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | No information |
Allocation concealment (selection bias) | Unclear risk | No information |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | No information |
Incomplete outcome data (attrition bias) All outcomes | High risk | Interim analysis in terms of both participant numbers and length of follow‐up for those participants recruited |
Selective reporting (reporting bias) | Unclear risk | No information |
Other bias | Unclear risk | No information; interim analysis ‐ not clear why further work not available |