Pilot feasibility randomized clinical trial of negative-pressure wound therapy <i>versus</i>
 usual care in patients with surgical wounds healing by secondary intention

Arundel, Catherine; Fairhurst, Caroline; Corbacho-Martin, B.; Buckley, Hannah; Clarke, Emma; Cullum, Nicky; Dixon, Stephen; Dumville, Jo C; Firth, Anna; Henderson, Eileen; Lamb, Karen; McGinnis, Elizabeth; Oswald, Angela; Gonçalves, Pedro; Soares, Marta; Stubbs, Nikki; Chetter, Ian

doi:10.1002/bjs5.49

Cited by 6 publications

(5 citation statements)

References 18 publications

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“…The majority of studies were performed in an inpatient setting (n = 38). In 47 studies, patients were randomised and in one study (Moisidis 2004 [107] [119]). Comparators were mostly described as standard wound care or standard dressings.…”

Section: Potential Publication Biasmentioning

confidence: 99%

Negative pressure wound therapy in patients with wounds healing by secondary intention: a systematic review and meta-analysis of randomised controlled trials

Zens

Barth²,

Bucher

et al. 2020

Syst Rev

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Background Negative pressure wound therapy (NPWT) is a widely used method of wound treatment. We performed a systematic review of randomised controlled trials (RCTs) comparing the patient-relevant benefits and harms of NPWT with standard wound therapy (SWT) in patients with wounds healing by secondary intention. Methods We searched for RCTs in MEDLINE, Embase, the Cochrane Central Register of Controlled Trials, and study registries (last search: July 2018) and screened reference lists of relevant systematic reviews and health technology assessments. Manufacturers and investigators were asked to provide unpublished data. Eligible studies investigated at least one patient-relevant outcome (e.g. wound closure). We assessed publication bias and, if feasible, performed meta-analyses, grading the results into different categories (hint, indication or proof of a greater benefit or harm). Results We identified 48 eligible studies of generally low quality with evaluable data for 4315 patients and 30 eligible studies with missing data for at least 1386 patients. Due to potential publication bias (proportion of inaccessible data, 24%), we downgraded our conclusions. A meta-analysis of all wound healing data showed a significant effect in favour of NPWT (OR 1.56, 95% CI 1.15 to 2.13, p = 0.008). As further analyses of different definitions of wound closure did not contradict that analysis, we inferred an indication of a greater benefit of NPWT. A meta-analysis of hospital stay (in days) showed a significant difference in favour of NPWT (MD − 4.78, 95% CI − 7.79 to − 1.76, p = 0.005). As further analyses of different definitions of hospital stay/readmission did not contradict that analysis, we inferred an indication of a greater benefit of NPWT. There was neither proof (nor indication nor hint) of greater benefit or harm of NPWT for other patient-relevant outcomes such as mortality and adverse events. Conclusions In summary, low-quality data indicate a greater benefit of NPWT versus SWT for wound closure in patients with wounds healing by secondary intention. The length of hospital stay is also shortened. The data show no advantages or disadvantages of NPWT for other patient-relevant outcomes. Publication bias is an important problem in studies on NPWT, underlining that all clinical studies need to be fully reported.

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Section: Potential Publication Biasmentioning

confidence: 99%

Negative pressure wound therapy in patients with wounds healing by secondary intention: a systematic review and meta-analysis of randomised controlled trials

Zens

Barth²,

Bucher

et al. 2020

Syst Rev

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“…These and other points for pre‐trial assessment are usually included in the site assessment/feasibility checklist . Although there are limited publications on feasibility studies in wound care, there is no checklist developed for site assessment to date.…”

Section: Discussionmentioning

confidence: 99%

Randomised controlled trials as part of clinical care: A seven‐step routinisation framework proposal

Team

Weller

2018

International Wound Journal

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Evidence translation in wound care relies on the need for evidence generation. Clinical practice may generate evidence only if evidence‐generating research projects, such as randomised controlled trials (RCTs), became routinised in clinical settings. The aim of this study was to identify optimal trial‐related practices to routinise trial‐related activities in Melbourne‐located wound clinics as reported by clinicians and researchers. We conducted a secondary analysis of the available data on how to routinise RCTs in clinical care, with a focus on enablers and suggestions provided by the participants during face‐to‐face and telephone interviews. Data were obtained from a qualitative observational study nested within a randomised, double‐blinded, placebo‐controlled trial on clinical effectiveness of aspirin as an adjunct to compression therapy in healing chronic venous leg ulcers (ASPiVLU). We developed a seven‐step Routinisation of Trials in Clinical Care Framework. These steps include: (1) pre‐trial clinical site assessment, (2) optimising pre‐recruitment arrangements, (3) developing and updating trial‐related skills, (4) embedding RCT recruitment as part of routine clinical care, (5) promoting teamwork and trial‐related collaboration, (6) addressing trial‐related financial issues, and (7) communicating trial results to clinicians.

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“…At baseline, epidemiological data will be collected including patient demographics, comorbidities, smoking status and surgical procedure details. Participants will complete a questionnaire comprising of a number of outcomes measures including surgical site infection (Bluebelle WHQ [ 17 ]), wound pain (using a visual analogue scale), quality of life (EuroQol EQ-5D-5L [ 19 ]) and resource use (using a bespoke, study specific questionnaire, which was designed based on the experiences learnt from the earlier feasibility study [ 27 ]).…”

Section: Methods: Participants Interventions and Outcomesmentioning

confidence: 99%

Negative pressure wound therapy versus usual care for surgical wounds healing by secondary intention (SWHSI-2 trial): study protocol for a pragmatic, multicentre, cross surgical specialty, randomised controlled trial

Chetter

Arundel

Martin

et al. 2021

Trials

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Background The majority of surgical wounds are closed (for example with sutures or staples) and so heal by primary intention. Where closure is not possible, or the wound subsequently breaks down, wounds may be left to heal from the bottom up (healing by secondary intention). Surgical wound healing by secondary intention (SWHSI) frequently presents a significant management challenge. Additional treatments are often required during the course of healing, and thus a significant financial burden is associated with treating these wounds. Increasingly, negative pressure wound therapy (NPWT) is used in the management of SWHSI. This wound dressing system provides a negative pressure (vacuum) to the wound, removing fluid into a canister, which is believed to be conducive to wound healing. Despite the increasing use of NPWT, there is limited robust evidence for the effectiveness of this device. A well-designed and conducted randomised controlled trial is now required to ascertain if NPWT is a clinically and cost-effective treatment for SWHSI. Methods SWHSI-2 is a pragmatic, multi-centre, cross surgical specialty, two arm, parallel group, randomised controlled superiority trial. Adult patients with a SWHSI will be randomised to receive either NPWT or usual care (no NPWT) and will be followed up for 12 months. The primary outcome will be time to healing (defined as full epithelial cover in absence of a scab) in number of days since randomisation. Secondary outcomes will include key clinical events (hospital admission or discharge, treatment status, reoperation, amputation, antibiotic use and death), wound infection, wound pain, health-related quality of life, health utility and resource use. Discussion Given the increasing use of NPWT, despite limited high-quality supporting evidence, the SWHSI-2 Trial will provide robust evidence on the clinical and cost-effectiveness of NPWT in the management of SWHSI. The SWHSI-2 Trial opened to recruitment in May 2019 and is currently recruiting across 20 participating centres. Trial registration ISRCTN 26277546. Prospectively registered on 25 March 2019

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Pilot feasibility randomized clinical trial of negative-pressure wound therapy versus usual care in patients with surgical wounds healing by secondary intention

Cited by 6 publications

References 18 publications

Negative pressure wound therapy in patients with wounds healing by secondary intention: a systematic review and meta-analysis of randomised controlled trials

Negative pressure wound therapy in patients with wounds healing by secondary intention: a systematic review and meta-analysis of randomised controlled trials

Randomised controlled trials as part of clinical care: A seven‐step routinisation framework proposal

Negative pressure wound therapy versus usual care for surgical wounds healing by secondary intention (SWHSI-2 trial): study protocol for a pragmatic, multicentre, cross surgical specialty, randomised controlled trial

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