A pilot randomised controlled trial of negative pressure wound therapy to treat grade III/IV pressure ulcers [ISRCTN69032034]
Identifieur interne : 004548 ( Main/Exploration ); précédent : 004547; suivant : 004549A pilot randomised controlled trial of negative pressure wound therapy to treat grade III/IV pressure ulcers [ISRCTN69032034]
Auteurs : Rebecca L. Ashby [Royaume-Uni] ; Jo C. Dumville [Royaume-Uni] ; Marta O. Soares [Royaume-Uni] ; Elizabeth Mcginnis [Royaume-Uni] ; Nikki Stubbs [Royaume-Uni] ; David J. Torgerson [Royaume-Uni] ; Nicky Cullum [Royaume-Uni]Source :
- Trials [ 1745-6215 ] ; 2012.
Abstract
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.
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.
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.
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.
Current Controlled Trials ISRCTN69032034.
Url:
DOI: 10.1186/1745-6215-13-119
PubMed: 22839453
PubMed Central: 3533804
Affiliations:
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Dumville</name><affiliation wicri:level="1"><nlm:aff id="I1">Department of Health Sciences, The University of York, York, UK</nlm:aff><country xml:lang="fr">Royaume-Uni</country><wicri:regionArea>Department of Health Sciences, The University of York, York</wicri:regionArea><wicri:noRegion>York</wicri:noRegion></affiliation></author><author><name sortKey="Soares, Marta O" sort="Soares, Marta O" uniqKey="Soares M" first="Marta O" last="Soares">Marta O. Soares</name><affiliation wicri:level="1"><nlm:aff id="I2">Centre for Health Economics, The University of York, York, UK</nlm:aff><country xml:lang="fr">Royaume-Uni</country><wicri:regionArea>Centre for Health Economics, The University of York, York</wicri:regionArea><wicri:noRegion>York</wicri:noRegion></affiliation></author><author><name sortKey="Mcginnis, Elizabeth" sort="Mcginnis, Elizabeth" uniqKey="Mcginnis E" first="Elizabeth" last="Mcginnis">Elizabeth Mcginnis</name><affiliation wicri:level="1"><nlm:aff id="I3">Leeds Teaching Hospitals NHS Trust, Leeds General Infirmary, Leeds, UK</nlm:aff><country xml:lang="fr">Royaume-Uni</country><wicri:regionArea>Leeds Teaching Hospitals NHS Trust, Leeds General Infirmary, Leeds</wicri:regionArea><wicri:noRegion>Leeds</wicri:noRegion></affiliation></author><author><name sortKey="Stubbs, Nikki" sort="Stubbs, Nikki" uniqKey="Stubbs N" first="Nikki" last="Stubbs">Nikki Stubbs</name><affiliation wicri:level="1"><nlm:aff id="I4">NHS Leeds Community Healthcare, St Mary's Hospital, Leeds, UK</nlm:aff><country xml:lang="fr">Royaume-Uni</country><wicri:regionArea>NHS Leeds Community Healthcare, St Mary's Hospital, Leeds</wicri:regionArea><wicri:noRegion>Leeds</wicri:noRegion></affiliation></author><author><name sortKey="Torgerson, David J" sort="Torgerson, David J" uniqKey="Torgerson D" first="David J" last="Torgerson">David J. 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Ashby</name><affiliation wicri:level="1"><nlm:aff id="I1">Department of Health Sciences, The University of York, York, UK</nlm:aff><country xml:lang="fr">Royaume-Uni</country><wicri:regionArea>Department of Health Sciences, The University of York, York</wicri:regionArea><wicri:noRegion>York</wicri:noRegion></affiliation></author><author><name sortKey="Dumville, Jo C" sort="Dumville, Jo C" uniqKey="Dumville J" first="Jo C" last="Dumville">Jo C. Dumville</name><affiliation wicri:level="1"><nlm:aff id="I1">Department of Health Sciences, The University of York, York, UK</nlm:aff><country xml:lang="fr">Royaume-Uni</country><wicri:regionArea>Department of Health Sciences, The University of York, York</wicri:regionArea><wicri:noRegion>York</wicri:noRegion></affiliation></author><author><name sortKey="Soares, Marta O" sort="Soares, Marta O" uniqKey="Soares M" first="Marta O" last="Soares">Marta O. Soares</name><affiliation wicri:level="1"><nlm:aff id="I2">Centre for Health Economics, The University of York, York, UK</nlm:aff><country xml:lang="fr">Royaume-Uni</country><wicri:regionArea>Centre for Health Economics, The University of York, York</wicri:regionArea><wicri:noRegion>York</wicri:noRegion></affiliation></author><author><name sortKey="Mcginnis, Elizabeth" sort="Mcginnis, Elizabeth" uniqKey="Mcginnis E" first="Elizabeth" last="Mcginnis">Elizabeth Mcginnis</name><affiliation wicri:level="1"><nlm:aff id="I3">Leeds Teaching Hospitals NHS Trust, Leeds General Infirmary, Leeds, UK</nlm:aff><country xml:lang="fr">Royaume-Uni</country><wicri:regionArea>Leeds Teaching Hospitals NHS Trust, Leeds General Infirmary, Leeds</wicri:regionArea><wicri:noRegion>Leeds</wicri:noRegion></affiliation></author><author><name sortKey="Stubbs, Nikki" sort="Stubbs, Nikki" uniqKey="Stubbs N" first="Nikki" last="Stubbs">Nikki Stubbs</name><affiliation wicri:level="1"><nlm:aff id="I4">NHS Leeds Community Healthcare, St Mary's Hospital, Leeds, UK</nlm:aff><country xml:lang="fr">Royaume-Uni</country><wicri:regionArea>NHS Leeds Community Healthcare, St Mary's Hospital, Leeds</wicri:regionArea><wicri:noRegion>Leeds</wicri:noRegion></affiliation></author><author><name sortKey="Torgerson, David J" sort="Torgerson, David J" uniqKey="Torgerson D" first="David J" last="Torgerson">David J. Torgerson</name><affiliation wicri:level="1"><nlm:aff id="I1">Department of Health Sciences, The University of York, York, UK</nlm:aff><country xml:lang="fr">Royaume-Uni</country><wicri:regionArea>Department of Health Sciences, The University of York, York</wicri:regionArea><wicri:noRegion>York</wicri:noRegion></affiliation></author><author><name sortKey="Cullum, Nicky" sort="Cullum, Nicky" uniqKey="Cullum N" first="Nicky" last="Cullum">Nicky Cullum</name><affiliation wicri:level="4"><nlm:aff id="I5">School of Nursing, Midwifery & Social Work, The University of Manchester, Manchester, UK</nlm:aff><country xml:lang="fr">Royaume-Uni</country><wicri:regionArea>School of Nursing, Midwifery & Social Work, The University of Manchester, Manchester</wicri:regionArea><placeName><settlement type="city">Manchester</settlement><region type="country">Angleterre</region><region type="région" nuts="1">Grand Manchester</region><settlement type="city">Manchester</settlement></placeName><orgName type="university">Université de Manchester</orgName></affiliation></author></analytic><series><title level="j">Trials</title><idno type="eISSN">1745-6215</idno><imprint><date when="2012">2012</date></imprint></series></biblStruct></sourceDesc></fileDesc><profileDesc><textClass></textClass></profileDesc></teiHeader><front><div type="abstract" xml:lang="en"><sec><title>Background</title><p>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.</p></sec><sec><title>Methods</title><p>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.</p></sec><sec><title>Results</title><p>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.</p></sec><sec><title>Conclusions</title><p>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.</p></sec><sec><title>Trial registration</title><p>Current Controlled Trials ISRCTN69032034.</p></sec></div></front><back><div1 type="bibliography"><listBibl><biblStruct><analytic><author><name sortKey="Banwell, Pe" uniqKey="Banwell P">PE Banwell</name></author><author><name sortKey="Musgrave, M" uniqKey="Musgrave M">M Musgrave</name></author></analytic></biblStruct><biblStruct></biblStruct><biblStruct><analytic><author><name sortKey="Philbeck, Te" uniqKey="Philbeck T">TE Philbeck</name></author><author><name sortKey="Whittington, Kt" uniqKey="Whittington K">KT Whittington</name></author><author><name sortKey="Millsap, Mh" uniqKey="Millsap M">MH Millsap</name></author><author><name sortKey="Briones, Rb" uniqKey="Briones R">RB Briones</name></author><author><name sortKey="Wight, Dg" uniqKey="Wight D">DG Wight</name></author><author><name 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L">L Ruhland</name></author><author><name sortKey="Casson, I" uniqKey="Casson I">I Casson</name></author><author><name sortKey="Macdonald, S" uniqKey="Macdonald S">S MacDonald</name></author><author><name sortKey="Delva, D" uniqKey="Delva D">D Delva</name></author><author><name sortKey="Birtwhistle, R" uniqKey="Birtwhistle R">R Birtwhistle</name></author><author><name sortKey="Lam, M" uniqKey="Lam M">M Lam</name></author><author><name sortKey="Seguin, R" uniqKey="Seguin R">R Seguin</name></author></analytic></biblStruct><biblStruct><analytic><author><name sortKey="Thorpe, Ke" uniqKey="Thorpe K">KE Thorpe</name></author><author><name sortKey="Zwarenstein, M" uniqKey="Zwarenstein M">M Zwarenstein</name></author><author><name sortKey="Oxman, Ad" uniqKey="Oxman A">AD Oxman</name></author><author><name sortKey="Treweek, S" uniqKey="Treweek S">S Treweek</name></author><author><name sortKey="Furberg, Cd" uniqKey="Furberg C">CD Furberg</name></author><author><name sortKey="Altman, Dg" uniqKey="Altman D">DG Altman</name></author><author><name sortKey="Tunis, S" uniqKey="Tunis S">S Tunis</name></author><author><name sortKey="Bergel, E" uniqKey="Bergel E">E Bergel</name></author><author><name sortKey="Harvey, I" uniqKey="Harvey I">I Harvey</name></author><author><name sortKey="Magid, Dj" uniqKey="Magid D">DJ Magid</name></author><author><name sortKey="Chalkidou, K" uniqKey="Chalkidou K">K Chalkidou</name></author></analytic></biblStruct></listBibl></div1></back></TEI><affiliations><list><country><li>Royaume-Uni</li></country><region><li>Angleterre</li><li>Grand Manchester</li></region><settlement><li>Manchester</li></settlement><orgName><li>Université de Manchester</li></orgName></list><tree><country name="Royaume-Uni"><noRegion><name sortKey="Ashby, Rebecca L" sort="Ashby, Rebecca L" uniqKey="Ashby R" first="Rebecca L" last="Ashby">Rebecca L. Ashby</name></noRegion><name sortKey="Cullum, Nicky" sort="Cullum, Nicky" uniqKey="Cullum N" first="Nicky" last="Cullum">Nicky Cullum</name><name sortKey="Dumville, Jo C" sort="Dumville, Jo C" uniqKey="Dumville J" first="Jo C" last="Dumville">Jo C. Dumville</name><name sortKey="Mcginnis, Elizabeth" sort="Mcginnis, Elizabeth" uniqKey="Mcginnis E" first="Elizabeth" last="Mcginnis">Elizabeth Mcginnis</name><name sortKey="Soares, Marta O" sort="Soares, Marta O" uniqKey="Soares M" first="Marta O" last="Soares">Marta O. Soares</name><name sortKey="Stubbs, Nikki" sort="Stubbs, Nikki" uniqKey="Stubbs N" first="Nikki" last="Stubbs">Nikki Stubbs</name><name sortKey="Torgerson, David J" sort="Torgerson, David J" uniqKey="Torgerson D" first="David J" last="Torgerson">David J. Torgerson</name></country></tree></affiliations></record>Pour manipuler ce document sous Unix (Dilib)
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