A properly blinded randomised trial, and it is not about adults
What it found
| Outcome | NPWT + Acticoat/Mepitel | Acticoat/Mepitel alone |
|---|---|---|
| Median time to re-epithelialisation | 8 days (IQR 7–11) | 10 days (IQR 8–14) |
| Expected time to wound closure | reduced by 22% (95% CI 7 to 34), P = 0.005 | — |
| Referral to scar management | risk reduced 60% (95% CI 18 to 81), P = 0.013 | — |
| Grafting | 1 patient | 4 patients |
| Pain, itch | no significant difference | |
| Laser Doppler perfusion | no significant difference |
114 children randomised. Ten discontinued early, which the authors attribute to the treatment burden of NPWT.
Limitations
- Single centre, 114 children. The 22% estimate has a wide interval, 7% to 34%.
- Scar-management referral is a clinician decision, not a measured outcome, and was secondary.
- Patients and treating staff could not be blinded; only the photographic assessor was.
- Ten early discontinuations in a trial of 114.
- Population entirely outside this practice's scope.
Appraisal and reference
CAT: OCEBM 1 · START HIGH — a prospectively registered, randomised, single-centre trial with blinded photographic outcome assessment, which is the hardest thing to achieve in NPWT research and is the reason most of this literature is downgraded. NOT downgraded for risk of bias on the primary outcome: allocation was randomised and the assessor could not see which arm a photograph came from. MINUS 1 for imprecision and single-centre conduct: 114 children in one unit, with the primary estimate a 22% reduction in expected time to closure whose interval runs from 7% to 34% — a wide band around a real effect. MINUS nothing for indirectness WITHIN its population and EVERYTHING for indirectness outside it: small-area thermal burns in children have no counterpart in an adult vascular caseload. NET MODERATE for the population studied. The scar-referral outcome is rated lower, at Low: a 60% relative reduction with an interval of 18 to 81% is a secondary endpoint with few events, referral is a clinician decision rather than a measured state, and it was not the trial's primary question.
Figures: Figures checked