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A pilot randomised controlled trial of negative pressure wound therapy to treat grade III/IV pressure ulcers [ISRCTN69032034]

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JournalTrials
DatePublished - 28 Jul 2012
Issue number1
Volume13
Pages (from-to)119
Original languageEnglish

Abstract

ABSTRACT: BACKGROUND: Negative pressure wound therapy (NPWT) is widely promoted as a treatment for full thickness wounds, however there is a lack of high-quality research evidence regarding its clinical and cost effectiveness. A trial of NPWT for the treatment grade III/IV pressure ulcers would be worthwhile but premature without assessing whether such a trial is feasible. The aim of this pilot randomised controlled trial was to assess the feasibility of conducting a future full trial of NPWT for the treatment of grade III and IV pressure ulcers and to pilot all aspects of the trial. METHODS: This was a two centre (acute and community), pilot randomised controlled trial. Eligible participants were randomised to receive either NPWT or Standard Care (SC) (spun hydrocolloid, alginate or foam dressings). The primary outcome measure was time to healing of the reference pressure ulcer. Secondary outcome measures included recruitment rates, frequency of treatment visits, resources used and duration of follow-up. RESULTS: 312 patients were screened for eligibility into this trial over a 12-month recruitment period and 12/312 participants (3.8%) were randomised; six to NPWT and six to SC. Only one reference pressure ulcer healed (NPWT group) during follow up (time to healing 79 days). The mean number of treatment visits per week was 3.1 (NPWT) and 5.7 (SC). 6/6 TNP and 1/6 SC participants withdrew from their allocated trial treatment. The mean duration of follow-up was 3.8 (NPWT) and 5.0 (SC) months. CONCLUSIONS: This pilot trial yielded vital information for the planning of any future full study including a projected recruitment rate, required duration of follow up and extent of research nurse support required. Data were also used to inform cost-effectiveness and value of information analyses which were conducted alongside the pilot trial.

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