| Methods |
RCT; participants randomised (> 1 wound per person, other selection of wound)
Funding: non‐industry funding ‐ MRC grant. NPWT units supplied by Kinetic Concepts Inc, but they had no input to the trial. Setting: hospital and community
Duration of follow = up to 26 weeks (6 months)
Unit of analysis: person (1 ulcer/person) |
| Participants |
12 participants with pressure ulcers. PU Stage: 3 (n = 7); 4 (n = 5) overall; data per group not stated (PU classification: NPUAP)
Age: median (IQR) 67.5 (54.5 to 82.0) years. Duration of ulcer: median (IQR): overall ‐ 4.0 months (2.2 to 28.5). Ulcer size: median: 3.0 cm wide x 5.0 cm long x 4 cm deep (overall)
Wound characteristics at baseline: no wounds infected; slough not reported; necrosis not reported; exudate not reported
Comment: deepest wound selected if more than 1 per person (but not stated if this occurred) |
| Interventions |
Group 1: standard care (all advanced dressings): hydrocolloid (fibrous hydrocolloid) dressing, a foam dressing or an alginate dressing (all non‐silver); n = 6. Grouped intervention category: advanced dressing
Group 2: ineligible intervention ‐ negative pressure wound therapy (PU was filled with either VAC WhiteFoamW or Granufoam dressings and VAC applied); n = 6). Grouped intervention category: ineligible ‐ NPWT |
| Outcomes |
Primary outcomes: proportion completely healed at 26 (6 months) weeks; time to complete healing not reported |
| Notes |
|
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Selection bias |
Low risk |
Sequence generation adequate ‐ computer‐generated. Allocation concealment adequate ‐ central randomisation with contact details or list held independently. Baseline comparability unclear ‐ baseline difference but unclear of importance. Rating: low |
| Blinding of outcome assessment (detection bias)
All outcomes |
Low risk |
Blinded to interventions (clear description) |
| Incomplete outcome data (attrition bias)
All outcomes |
High risk |
Missing data: Group 1 ‐ 1/6 (17%) withdrew from treatment and received other treatment; 0/6 died (PU slow to heal). Group 2 ‐ 6/6 (100%) withdrew from treatment and received other treatment. 2/6 (33%) died during the trial (1 recurrence of black slough, 1 ulcer too small to continue treatment, 1 foam embedded in granulation tissue, 1 deterioration, 1 participant refusal, 1 difficulty with applying treatment)
i.e. differential missing data rates; high differential rate – likely to change effect estimate |
| Selective reporting (reporting bias) |
Low risk |
Adequate ‐ full results reported |
| Other bias
unit of analysis |
Low risk |
Unit of randomisation person and unit of analysis person (1 ulcer/person) |
| Other bias
additional |
Low risk |
The study appears to be free of other sources of bias |
| ALL‐DOMAIN RISK OF BIAS |
High risk |
Rating: high
Reasons: differential missing data due to death; also differential switching to other treatments
Comments: attrition bias (death); small trial, but more comorbidities in NPWT group |
