Lavery 2014.
| Methods | 2‐arm RCT undertaken in the USA | |
| Participants | 40 participants Inclusion criteria: people with DM aged 21–90 years, surgical lower extremity wounds (diabetic foot wounds after incision and drainage or amputation for infection), and ankle‐brachial indices > 0.70 Exclusion criteria: not reported Key baselines covariates: Wound area (cm²): Group A: 20.1 (SD 14.3) Group B: 34.6 (SD 32.9) Wound volume (cm³): Group A: 35.1 (SD 33.0) Group B: 65.3 (SD 69.9) History of amputation: Group A: 65% Group B: 65% Wound duration: not reported |
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| Interventions | Group A (n = 20): 75 mmHg continuous pressure with a silicone‐coated dressing (Engenex with Bio‐Dome Technology; ConvaTec, Skillman, NJ) Group B (n = 20): 125 mmHg continuous pressure with a polyurethane foam dressing (V.A.C. with GranuFoam dressing; Kinetic Concepts, Inc., San Antonio, TX) |
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| Outcomes | Primary review outcomes: no review relevant outcome reported Secondary review outcomes: number of wounds closed or covered with surgery; adverse events (we used data from Table 4 in the paper – 3 vs 2; however, discrepancy between table and text which suggests 3 vs 1) |
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| Notes | Follow‐up: 4 weeks Both NPWT devices were changed 3 times per week. |
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| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Quote: "randomised from a computer‐generated list" Comment: classed as an adequate method |
| Allocation concealment (selection bias) | Unclear risk | Not reported |
| Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Comment: it is understandably not possible to blind participants and investigators to whether or not they receive NPWT. However, given this, it is important that any decision‐making that might be affected by performance bias is recognised and blinding is introduced where possible. We noted that unblinded health professionals were able to make decisions about undertaking closure surgery that could then have resulted in more wounds being closed (and classed as healed) or amputated in 1 group compared with the other. As a result of this, we classed the risk of bias for this domain as unclear. |
| Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Not reported |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | Comment: no evidence of incomplete outcome data |
| Other bias | Low risk | No evidence of other risk of bias |