Trial reportTrials2012
A pilot randomised controlled trial of negative pressure wound therapy to treat grade III/IV pressure ulcers [ISRCTN69032034].
Trial report in Trials, 2012. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 14 papers, 5 of them syntheses that pooled it.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
14 citing papers in PubMed, 5 syntheses or guidelines pooled it.
- Reconstructive surgery for treating pressure ulcers.The Cochrane database of systematic reviews · 2022Pooled it
- Negative pressure wound therapy in patients with wounds healing by secondary intention: a systematic review and meta-analysis of randomised controlled trials.Systematic reviews · 2020Pooled it
- Foam dressings for treating pressure ulcers.The Cochrane database of systematic reviews · 2017Pooled it
- Dressings and topical agents for treating pressure ulcers.The Cochrane database of systematic reviews · 2017Pooled it
- Reconstructive surgery for treating pressure ulcers.The Cochrane database of systematic reviews · 2016Pooled it
- Ambulatory negative pressure wound therapy of subcutaneous abdominal wounds after surgery: results of the SAWHI randomized clinical trial.BMC surgery · 2022Trial
- Trial
- Trial
- Negative pressure wound therapy for treating pressure ulcers.The Cochrane database of systematic reviews · 2023Review
- Remote assessment of surgical site infection (SSI) using patient-taken wound images: Development and evaluation of a method for research and routine practice.Journal of tissue viability · 2023Review
- Pre-Clinical Assessment of Single-Use Negative Pressure Wound Therapy DuringAdvances in wound care · 2021Article
- Management of Grade IV Pressure Ulcers With a Novel Negative Pressure Device in Traumatic Paraplegia Subjects.Cureus · 2020Article
- Use of controlled negative pressure in management of phlegmon caused by fulminant complication of pressure wound: A case report.Medicine · 2018Article
- Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
7 authors.
Funding
Abstract
backgroundNegative 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 of 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.
methodsThis 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). Outcome measures were time to healing of the reference pressure ulcer, recruitment rates, frequency of treatment visits, resources used and duration of follow-up.
resultsThree hundred and twelve patients were screened for eligibility into this trial over a 12-month recruitment period and 12/312 participants (3.8%) were randomised: 6 to NPWT and 6 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 NPWT 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.
conclusionsThis pilot trial yielded vital information for the planning of a future full study including projected recruitment rate, required duration of follow-up and extent of research nurse support required. Data were also used to inform the cost-effectiveness and value of information analyses, which were conducted alongside the pilot trial.
trial registrationCurrent Controlled Trials ISRCTN69032034.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.