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

Ashby, Rebecca L., Dumville, Jo C., Soares, Marta O., McGinnis, Elizabeth, Stubbs, Nikki, Torgerson, David J. and Cullum, Nicky (2012) A pilot randomised controlled trial of negative pressure wound therapy to treat grade III/IV pressure ulcers [ISRCTN69032034]. Trials, 13 119: . doi:10.1186/1745-6215-13-119


Author Ashby, Rebecca L.
Dumville, Jo C.
Soares, Marta O.
McGinnis, Elizabeth
Stubbs, Nikki
Torgerson, David J.
Cullum, Nicky
Title A pilot randomised controlled trial of negative pressure wound therapy to treat grade III/IV pressure ulcers [ISRCTN69032034]
Journal name Trials   Check publisher's open access policy
ISSN 1745-6215
1468-6708
Publication date 2012-07-01
Sub-type Article (original research)
DOI 10.1186/1745-6215-13-119
Open Access Status DOI
Volume 13
Issue 119
Total pages 16
Place of publication London, United Kingdom
Publisher BioMed
Language eng
Formatted 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 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.

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). Outcome measures were time to healing of the reference pressure ulcer, recruitment rates, frequency of treatment visits, resources used and duration of follow-up.

Results
Three 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.

Conclusions
This 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.
Keyword Negative pressure wound therapy
Pressure ulcer
Pilot randomised controlled trial
Q-Index Code C1
Q-Index Status Provisional Code
Institutional Status Non-UQ

Document type: Journal Article
Sub-type: Article (original research)
Collection: School of Nursing, Midwifery and Social Work Publications
 
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Created: Thu, 22 May 2014, 20:13:38 EST by Vicki Percival on behalf of School of Nursing, Midwifery and Social Work