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Cochrane Database of Systematic Reviews

Tratamiento de heridas con presión negativa para el tratamiento de las heridas del pie en los pacientes con diabetes mellitus

Information

DOI:
https://doi.org/10.1002/14651858.CD010318.pub3Copy DOI
Database:
  1. Cochrane Database of Systematic Reviews
Version published:
  1. 17 October 2018see what's new
Type:
  1. Intervention
Stage:
  1. Review
Cochrane Editorial Group:
  1. Cochrane Wounds Group

Copyright:
  1. Copyright © 2018 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.

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Authors

  • Zhenmi Liu

    Correspondence to: West China School of Public Health, West China Hospital, Sichuan University, Chengdu, China

    [email protected]

    Division of Nursing, Midwifery and Social Work, School of Health Sciences, Faculty of Biology, Medicine and Health, University of Manchester, Manchester Academic Health Science Centre, Manchester, UK

  • Jo C Dumville

    Division of Nursing, Midwifery and Social Work, School of Health Sciences, Faculty of Biology, Medicine and Health, University of Manchester, Manchester Academic Health Science Centre, Manchester, UK

  • Robert J Hinchliffe

    St George's Vascular Institute, St George's Healthcare NHS Trust, London, UK

  • Nicky Cullum

    Division of Nursing, Midwifery and Social Work, School of Health Sciences, Faculty of Biology, Medicine and Health, University of Manchester, Manchester Academic Health Science Centre, Manchester, UK

  • Fran Game

    Department of Diabetes and Endocrinology, Derby Hospitals NHS Foundation Trust, Derby, UK

  • Nikki Stubbs

    Leeds Community Healthcare NHS Trust, St Mary's Hospital, Leeds, UK

  • Michael Sweeting

    Department of Health Sciences, College of Life Sciences, University of Leicester, Leicester, UK

  • Frank Peinemann

    Pediatric Oncology and Hematology, Children's Hospital, University of Cologne, Cologne, Germany

Contributions of authors

Zhenmi Liu: co‐ordinated the review update; extracted data; checked the quality of data extraction; analysed or interpreted data; undertook and checked quality assessment; performed statistical analysis; checked the quality of the statistical analysis; produced the first draft of the review update; contributed to writing or editing the review update; advised on the review update; secured funding; performed previous work that was the foundation of the current review update; wrote to study authors, experts and companies; performed economic analysis; performed translations; approved the final review update prior to submission; and is a guarantor of the review update.

Jo Dumville: conceived the review; designed and co‐ordinated the review update; extracted data; checked the quality of data extraction; analysed or interpreted data; undertook and checked quality assessment; checked the quality of the statistical analysis; contributed to writing or editing the review update; advised on the review update; secured funding; performed previous work that was the foundation of the current review update and approved the final review update prior to submission.

Robert Hinchliffe: co‐ordinated the review update; advised on the review update; performed previous work that was the foundation of the current review update and approved the final review update prior to submission.

Nicky Cullum: co‐ordinated the review update; advised on the review update; performed previous work that was the foundation of the current review update and approved the final review update prior to submission.

Fran Game: co‐ordinated the review update; advised on the review update; performed previous work that was the foundation of the current review update and approved the final review update prior to submission.

Nikki Stubbs: co‐ordinated the review update; advised on the review update and performed previous work that was the foundation of the current review update.

Michael Sweeting: co‐ordinated the review update; advised on the review update and performed previous work that was the foundation of the current review update.

Frank Peinemann: co‐ordinated the review update; advised on the review update and performed previous work that was the foundation of the current review update.

Contributions of editorial base

Joan Webster (Editor): edited the review and the update, advised on methodology, interpretation and content and approved the final version for publication.

Sally Bell‐Syer and Gill Rizzello (Managing Editors): co‐ordinated the editorial process. Advised on interpretation and content. Edited the review and the update respectively.

Ruth Foxlee and Naomi Shaw (Information Specialists): designed and edited the search strategy, edited the methods section and ran the searches for the review and update respectively.

Rachel Richardson (Methodologist): edited the review.

Ursula Gonthier (Editorial Assistant): edited the Plain language summary and the reference sections.

Sources of support

Internal sources

  • Division of Nursing, Midwifery and Social Work, School of Health Sciences, Faculty of Biology, Medicine and Health, University of Manchester, UK, UK.

External sources

  • National Institute for Health Research (NIHR), UK.

    This project was supported by the NIHR, via Cochrane Infrastructure and Cochrane Programme Grant funding (NIHR Cochrane Programme Grant 13/89/08 ‐ High Priority Cochrane Reviews in Wound Prevention and Treatment) to Cochrane Wounds. The views and opinions expressed herein are those of the authors and do not necessarily reflect those of the Systematic Reviews Programme, the NIHR, the NHS or the Department of Health.

  • NIHR Manchester Biomedical Research Centre (BRC), UK.

    This research was co‐funded by the NIHR Manchester BRC. The views expressed in this publication are those of the authors and not necessarily those of the NHS, the National Institute for Health Research or the Department of Health.

  • National Institute for Health Research Collaboration for Leadership in Applied Health Research and Care (NIHR CLAHRC), Greater Manchester, UK.

    Nicky Cullum and Jo Dumville's work on this project was partly funded by the NIHR CLAHRC, Greater Manchester. The funder had no role in the decision to publish, or preparation of the manuscript. However, the review may be considered to be affiliated to the work of the NIHR CLAHRC Greater Manchester. The views expressed herein are those of the authors and not necessarily those of the NHS, NIHR or the Department of Health.

  • National Institute for Health Research (NIHR) Systematic Review Fellowships (NIHR‐RMFI‐2015‐06‐52 Zhenmi Liu), UK.

Declarations of interest

Zhenmi Liu: my employment at the University of Manchester was supported by a grant from the National Institute for Health Research (NIHR) UK (NIHR Systematic Review Fellowships).

Jo Dumville: received research funding from the National Institute for Health Research (NIHR) UK for the production of systematic reviews focusing on high priority Cochrane Reviews in the prevention and treatment of wounds. This research was co‐funded by the NIHR Manchester Biomedical Research Centre and partly funded by the National Institute for Health Research Collaboration for Leadership in Applied Health Research and Care (NIHR CLAHRC) Greater Manchester.

Robert Hinchliffe: none known.

Nicky Cullum: received research funding from the National Institute for Health Research (NIHR) UK for wounds‐related research and systematic reviews focusing on high priority Cochrane Reviews in the prevention and treatment of wounds. This research was co‐funded by the NIHR Manchester Biomedical Research Centre and partly funded by the National Institute for Health Research Collaboration for Leadership in Applied Health Research and Care (NIHR CLAHRC) Greater Manchester.

Fran Game: grant funding was provided to Derby Teaching Hospitals NHS FT for a researcher led, NHS sponsored trial into a device for wound healing for the diabetic foot by the manufacturer of the device, Reapplix ApS Denmark. Grant funding was also provided to Derby Teaching Hospitals NHS FT for an investigator led, NHS sponsored trial into wound healing, using Omnigen by the manufacturers of the product, NuVision.

Nikki Stubbs: has received payments for Cogora, a healthcare marketing agency and expenses for conference attendance. She has received funding from pharmaceutical companies to support non product‐related training and education events in the UK National Health Service that were unrelated to the subject matter of this systematic review.

Michael Sweeting: none known.

Frank Peinemann: none known.

Acknowledgements

The review authors would like to acknowledge the contributions of peer reviewers to the previously published version of this review: Andrew Jull, Janet Gunderson and Gill Worthy, and to thank Kurinchi Gurusamy and Sharon Van Wicklin for their comments on this update. They would also like to thank Elizabeth Royle for copy editing the review and Anne Lawson for copy editing this update.

Version history

Published

Title

Stage

Authors

Version

2018 Oct 17

Negative pressure wound therapy for treating foot wounds in people with diabetes mellitus

Review

Zhenmi Liu, Jo C Dumville, Robert J Hinchliffe, Nicky Cullum, Fran Game, Nikki Stubbs, Michael Sweeting, Frank Peinemann

https://doi.org/10.1002/14651858.CD010318.pub3

2013 Oct 17

Negative pressure wound therapy for treating foot wounds in people with diabetes mellitus

Review

Jo C Dumville, Robert J Hinchliffe, Nicky Cullum, Fran Game, Nikki Stubbs, Michael Sweeting, Frank Peinemann

https://doi.org/10.1002/14651858.CD010318.pub2

2013 Jan 31

Negative pressure wound therapy for treating foot wounds in people with diabetes mellitus

Protocol

Jo C Dumville, Robert J Hinchliffe, Nicky Cullum, Fran Game, Nikki Stubbs, Michael Sweeting

https://doi.org/10.1002/14651858.CD010318

Differences between protocol and review

We have populated sections of the 'Methods' and 'Discussion' which were previously not available in the older version of Review Manager as follows: Assessment of reporting biases; Overall completeness and applicability of evidence.

Description of the condition: we added additional information to the 'Background' section.

Types of outcome measures: we removed 'change (and rate of change) in wound size' as this is not 'complete wound healing.' We also made a post hoc decision to assess 'cost‐effectiveness' rather than 'resource use.' This is an important outcome from both clinical and practical perspective and negative pressure wound therapy (NPWT) is used widely but very expensive. We also added 'number of wounds closed or covered with surgery' and 'time to closure or coverage surgery' as secondary outcomes as they are clinically relevant outcomes, differing from the outcome of 'complete wound healing.'

Summary of findings: we decided to downgrade when the 'Risk of bias' assessment for selection bias or blinding was unclear. We also added these outcomes: number of wounds closed or covered with surgery; adverse events; cost‐effectiveness and wound recurrence to the 'Summary of findings' tables.

Due to the new included studies which included various types of dressings, we carried out a post hoc subgroup analysis based on the type of dressings.

Keywords

MeSH

PICOs

Population
Intervention
Comparison
Outcome

The PICO model is widely used and taught in evidence-based health care as a strategy for formulating questions and search strategies and for characterizing clinical studies or meta-analyses. PICO stands for four different potential components of a clinical question: Patient, Population or Problem; Intervention; Comparison; Outcome.

See more on using PICO in the Cochrane Handbook.

Study flow diagram (Liberati 2009)
Figures and Tables -
Figure 1

Study flow diagram (Liberati 2009)

Risk of bias graph: review authors' judgements about each risk of bias item presented as percentages across all included studies.
Figures and Tables -
Figure 2

Risk of bias graph: review authors' judgements about each risk of bias item presented as percentages across all included studies.

Risk of bias summary: review authors' judgements about each risk of bias item for each included study.
Figures and Tables -
Figure 3

Risk of bias summary: review authors' judgements about each risk of bias item for each included study.

Comparison 1 Negative pressure wound therapy (NPWT) compared with dressings in postoperative wounds, Outcome 1 Proportion of wounds healed.
Figures and Tables -
Analysis 1.1

Comparison 1 Negative pressure wound therapy (NPWT) compared with dressings in postoperative wounds, Outcome 1 Proportion of wounds healed.

Comparison 1 Negative pressure wound therapy (NPWT) compared with dressings in postoperative wounds, Outcome 2 Time to healing.
Figures and Tables -
Analysis 1.2

Comparison 1 Negative pressure wound therapy (NPWT) compared with dressings in postoperative wounds, Outcome 2 Time to healing.

Comparison 1 Negative pressure wound therapy (NPWT) compared with dressings in postoperative wounds, Outcome 3 Amputations.
Figures and Tables -
Analysis 1.3

Comparison 1 Negative pressure wound therapy (NPWT) compared with dressings in postoperative wounds, Outcome 3 Amputations.

Comparison 1 Negative pressure wound therapy (NPWT) compared with dressings in postoperative wounds, Outcome 4 Number of wounds closed or covered with surgery.
Figures and Tables -
Analysis 1.4

Comparison 1 Negative pressure wound therapy (NPWT) compared with dressings in postoperative wounds, Outcome 4 Number of wounds closed or covered with surgery.

Comparison 1 Negative pressure wound therapy (NPWT) compared with dressings in postoperative wounds, Outcome 5 Adverse events.
Figures and Tables -
Analysis 1.5

Comparison 1 Negative pressure wound therapy (NPWT) compared with dressings in postoperative wounds, Outcome 5 Adverse events.

Comparison 2 NPWT compared with dressings in diabetic foot ulcers, Outcome 1 Proportion of wounds healed.
Figures and Tables -
Analysis 2.1

Comparison 2 NPWT compared with dressings in diabetic foot ulcers, Outcome 1 Proportion of wounds healed.

Comparison 2 NPWT compared with dressings in diabetic foot ulcers, Outcome 2 Amputations.
Figures and Tables -
Analysis 2.2

Comparison 2 NPWT compared with dressings in diabetic foot ulcers, Outcome 2 Amputations.

Comparison 2 NPWT compared with dressings in diabetic foot ulcers, Outcome 3 Number of wounds closed or covered with surgery.
Figures and Tables -
Analysis 2.3

Comparison 2 NPWT compared with dressings in diabetic foot ulcers, Outcome 3 Number of wounds closed or covered with surgery.

Comparison 2 NPWT compared with dressings in diabetic foot ulcers, Outcome 4 Wound recurrence.
Figures and Tables -
Analysis 2.4

Comparison 2 NPWT compared with dressings in diabetic foot ulcers, Outcome 4 Wound recurrence.

Comparison 3 Low compared with high pressure of NPWT in diabetic foot ulcers, Outcome 1 Number of wounds closed or covered with surgery.
Figures and Tables -
Analysis 3.1

Comparison 3 Low compared with high pressure of NPWT in diabetic foot ulcers, Outcome 1 Number of wounds closed or covered with surgery.

Comparison 3 Low compared with high pressure of NPWT in diabetic foot ulcers, Outcome 2 Adverse events.
Figures and Tables -
Analysis 3.2

Comparison 3 Low compared with high pressure of NPWT in diabetic foot ulcers, Outcome 2 Adverse events.

Summary of findings for the main comparison. NPWT compared with dressings for postoperative foot wounds in people with diabetes mellitus

NPWT compared with dressings for postoperative wounds

Patient or population: treating foot wounds in people with diabetes mellitus

Setting: hospital

Intervention: NPWT

Comparison: dressings

Outcomes

Anticipated absolute effects* (95% CI)

Relative effect
(95% CI)

№ of participants
(studies)

Certainty of the evidence
(GRADE)

Comments

Risk with placebo

Risk with NPWT compared with dressings

Proportion of wounds healed

Follow‐up: 16 weeks

Study population

RR 1.44
(1.03 to 2.01)

162

(1 study)

⊕⊕⊝⊝

Lowa,b

388 per 1000

559 per 1000
(400 to 780)

Time to healing

Follow‐up: 16 weeks

Study population

HR 1.91
(1.21 to 2.99)

162

(1 study)

⊕⊕⊝⊝

Lowa,b

388 per 1000

609 per 1000
(448 to 770)

Amputations

Follow‐up: 16 weeks or unspecified

Study population

RR 0.38
(0.14 to 1.02)

292

(2 studies)

⊕⊝⊝⊝

Very lowa,c

60 per 1000

23 per 1000
(8 to 61)

Number of wounds closed or covered with surgery

954 per 1000

1000 per 1000
(238 to 1000)

RR 1.02
(0.95 to 1.09)

130

(1 study)

⊕⊝⊝⊝

Very lowa,c

Adverse events

Follow‐up: 16 weeks

Study population

RR 0.96
(0.72 to 1.28)

162

(1 study)

⊕⊝⊝⊝

Very lowa,c

541 per 1000

520 per 1000
(390 to 693)

Cost‐effectiveness

Not estimable

Not estimable

Not estimable

Not estimable

Not estimable

Wound recurrence

Not estimable

Not estimable

Not estimable

Not estimable

Not estimable

*The risk in the intervention group (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI).

CI: confidence interval; NPWT: negative pressure wound therapy; RR: risk ratio.

GRADE Working Group grades of evidence
High certainty: we are very confident that the true effect lies close to that of the estimate of the effect.
Moderate certainty: we are moderately confident in the effect estimate: the true effect is likely to be close to the estimate of the effect, but there is a possibility that it is substantially different.
Low certainty: our confidence in the effect estimate is limited: the true effect may be substantially different from the estimate of the effect.
Very low certainty: we have very little confidence in the effect estimate: the true effect is likely to be substantially different from the estimate of effect.

aDowngraded one level due to risk of bias: some blinded outcome assessment, but not sure the potential impact of non‐blinded decisions regarding the use of further surgery and the risk of performance bias.
bDowngraded one level due to imprecision: small sample size and wide 95% confidence intervals.
cDowngraded two levels due to imprecision: few events and 95% confidence intervals around effects included both appreciable benefit and appreciate harm.

Figures and Tables -
Summary of findings for the main comparison. NPWT compared with dressings for postoperative foot wounds in people with diabetes mellitus
Summary of findings 2. NPWT compared with dressings for foot ulcers in people with diabetes mellitus

NPWT compared with dressings for diabetic foot ulcers

Patient or population: treating foot wounds in people with diabetes mellitus

Setting: hospital

Intervention: NPWT

Comparison: dressings

Outcomes

Anticipated absolute effects* (95% CI)

Relative effect
(95% CI)

№ of participants
(studies)

Certainty of the evidence
(GRADE)

Comments

Risk with placebo

Risk with NPWT compared with dressings

Proportion of wounds healed

Follow‐up: unclear for 4 studies and 8–16 weeks for the other 3 studies

Study population

RR 1.40
(1.14 to 1.72)

486
(5 studies)

⊕⊕⊝⊝

Lowa,b

406 per 1000

540 per 1000
(475 to 617)

Time to healing

Follow‐up: unclear for 2 studies and 16 weeks for the other study

Study population

468

(3 studies)

⊕⊕⊝⊝

Lowa,b

3 studies reported HR, median and mean (1 each) and we were unable to pool any data for this comparison.

See comment

See comment

Amputations

Follow‐up: unclear for 4 studies and 16 weeks for the other study

Study population

RR 0.33
(0.15 to 0.70)

441
(3 studies)

⊕⊕⊝⊝

Lowa,b

114 per 1000

38 per 1000
(17 to 80)

Number of wounds closed or covered with surgery

Follow‐up: unclear

Study population

RR 1.02
(0.85 to 1.24)

129
(3 studies)

⊕⊕⊝⊝

Lowa,b

714 per 1000

729 per 1000
(607 to 886)

Adverse events

Not estimable

Not estimable

Not estimable

Not estimable

Not estimable

Cost‐effectiveness

Not estimable

Not estimable

Not estimable

Not estimable

Not estimable

Wound recurrence

Follow‐up: 6–10 months

Study population

RR 0.50

(0.10 to 2.53)

60
(1 study)

⊕⊝⊝⊝

Very lowa,c

133 per 1000

66 per 1000
(12 to 297)

*The risk in the intervention group (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI).

CI: confidence interval; NPWT: negative pressure wound therapy; HR: hazard ratio; RR: risk ratio.

GRADE Working Group grades of evidence
High certainty: we are very confident that the true effect lies close to that of the estimate of the effect.
Moderate certainty: we are moderately confident in the effect estimate: the true effect is likely to be close to the estimate of the effect, but there is a possibility that it is substantially different.
Low certainty: our confidence in the effect estimate is limited: the true effect may be substantially different from the estimate of the effect.
Very low certainty: we have very little confidence in the effect estimate: the true effect is likely to be substantially different from the estimate of effect.

aDowngraded one level due to risk of bias (no blind outcome assessment).
bDowngraded one level due to imprecision: small sample size and wide 95% confidence intervals.
cDowngraded two levels due to very serious Imprecision.

Figures and Tables -
Summary of findings 2. NPWT compared with dressings for foot ulcers in people with diabetes mellitus
Summary of findings 3. Low‐pressure compared with high‐pressure NPWT for foot ulcers in people with diabetes mellitus

Low‐pressure compared with high‐pressure NPWT for diabetic foot ulcers

Patient or population: treating foot wounds in people with diabetes mellitus

Setting: hospital

Intervention: low‐pressure NPWT (75 mmHg)

Comparison: high‐pressure NPWT (125 mmHg)

Outcomes

Anticipated absolute effects* (95% CI)

Relative effect
(95% CI)

№ of participants
(studies)

Certainty of the evidence
(GRADE)

Comments

Risk with placebo

Risk with low compared with high pressure of NPWT

Proportion of wounds healed

Not estimable

Not estimable

Not estimable

Not estimable

Not estimable

Time to ulcer healing

Not estimable

Not estimable

Not estimable

Not estimable

Not estimable

Amputation

Not estimable

Not estimable

Not estimable

Not estimable

Not estimable

Number of wounds closed or covered with surgery

Follow‐up: 4 weeks

Study population

RR 0.83
(0.47 to 1.47)

40
(1 study)

⊕⊝⊝⊝

Very lowa

600 per 1000

498 per 1000
(282 to 882)

Adverse events

Follow‐up: 4 weeks

Study population

RR 1.50
(0.28 to 8.04)

40
(1 study)

⊕⊝⊝⊝

Very lowa

100 per 1000

150 per 1000
(28 to 804)

Cost‐effectiveness

Not estimable

Not estimable

Not estimable

Not estimable

Not estimable

Wound recurrence

Not estimable

Not estimable

Not estimable

Not estimable

Not estimable

*The risk in the intervention group (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI).

CI: confidence interval; NPWT: negative pressure wound therapy; RR: risk ratio.

GRADE Working Group grades of evidence
High certainty: we are very confident that the true effect lies close to that of the estimate of the effect.
Moderate certainty: we are moderately confident in the effect estimate: the true effect is likely to be close to the estimate of the effect, but there is a possibility that it is substantially different.
Low certainty: our confidence in the effect estimate is limited: the true effect may be substantially different from the estimate of the effect.
Very low certainty: we have very little confidence in the effect estimate: the true effect is likely to be substantially different from the estimate of effect.

aDowngraded three levels: once for risk of bias (some blinded outcome assessment, but not sure the potential impact of non‐blinded decisions regarding the use of further surgery and the risk of performance bias); twice for very serious imprecision with a small sample size and limited reported information to quantify imprecision.

Figures and Tables -
Summary of findings 3. Low‐pressure compared with high‐pressure NPWT for foot ulcers in people with diabetes mellitus
Table 1. Study details

Study

Wound characteristics

Comparison

Length of follow‐up

NPWT pathways

Time to healing

Number of wounds completely healed

Amputation

Number of wounds closed or covered with surgery

Time to closure or coverage surgery

Adverse events

Health‐related quality of life

Cost‐effectiveness

Wound recurrence

Armstrong 2005

Diabetic foot amputation to trans‐metatarsal level

Group A: NPWT (V.A.C. system), dressing changes every 48 h. Treatment conducted until wound closure or completion of 112‐day assessment (n = 77)

Group B: moist wound therapy with alginates, hydrocolloid, foam or hydrogel dressings (n = 85)

16 weeks

After amputation (close/open wounds; if open wounds, secondary intention), NPWT delivered through the V.A.C. system; or standard care with moist wound therapy.

Kaplan‐Meier median time to healing

Group A: 56 days (IQR 26 to 92)

Group B: 77 days (IQR 40 to 122)

Log‐rank taken as P = 0.005

There was no difference noted in time to healing for acute or chronic wounds.

Group A: 43/77 (55.8%)

Group B: 33/85 (38.8%)

Of healed woundshealed by secondary intention (without primary/surgical wound closure)

Group A: 31/43 (72.1%)

Group B: 25/33 (75.8%)

Remaining wounds were closed following surgery.

Number of participants undergoing further amputation

Group A: 2/77 (2.3%)

Major = 0 Minor = 2

Group B: 9/85 (10.6%)

Major = 5

Minor = 4

Not reported

Not reported

Participants who had ≥ 1 adverse events

Group A: 40/77 (51.9%)

Group B: 46/85 (54.1%)

Participants who had ≥ 1 treatment‐related adverse events

Group A: 9/77 (11.7%)

1 classified serious

Group B: 11/85 (12.9%)

5 classified as serious

Not reported

Not reported

Not reported

Blume 2008

Ulceration of the foot in people with diabetes

Group A: NPWT (V.A.C. system), applied according to manufacturer’s instructions (n = 172)

Group B: advanced moist wound therapy dressings used according to guidelines/local protocols (n = 169)

16 weeks

NPWT was continued until ulcer closure.

Kaplan‐Meier median time to healing

Group A: 96 days (95% CI 75.0 to 114.0)

Group B: could not be estimated

Log‐rank taken as P = 0.001

Group A: 3/172 (42.4%)

Group B: 8/169 (28.4%)

(6 participants excluded in paper as did not receive treatment, added back into denominator here; ITT 172/169)

Number of participants undergoing amputation*

Group A: 7/172 (4.1%)

Major = 5

Minor = 2

Group B: 17/169 (10.1%)

Major = 4

Minor = 13

Not reported

Not reported

Limited data: not extracted

Not reported

Not reported

Not reported

Dalla‐Paola 2010

Infected open amputations or surgical dehiscence of minor amputations in people with diabetes

Group A: V.A.C. therapy following surgical debridement (n = 65)

Group B: advanced dressings following surgical debridement (n = 65)

Not specified. End of therapy was defined as complete coverage of the wound with epithelial tissue.

Duration of therapy depended on the functional parameters of the wound area.

Not reported

Not reported

Number of participants undergoing further amputation (major)

Group A: 3/65 (4.6%)

Group B: 5/65 (7.7%)

Group A: 63/65 (96.9%) Group B: 62/65 (95.4%)

Group A (n = 65): 65 days (SD 16)

Group B (n = 65): 98 days (SD 45)

P = 0.005

These data reported as time to "complete closure of the wound" was reached. Unclear if it is mean or median; unclear if "complete closure" means "time to healing of grafted wound" or "time to surgical closure;" unclear if it is a valid measure as not sure all ulcers have healed.

Author contacted – waiting for response.

Not reported

Not reported

Not reported

Not reported

Karatepe 2011

Diabetic foot ulcers

Group A: NPWT (V.A.C. system) (n = 30)

Group B: conventional wound care treatment: based on text in report taken to be dry gauze (n = 37)

Not specified. Last assessment 1 month after healing

Not specified

Median time to healing

Group A: 4.4 weeks

Group B: 3.9 weeks

Mean value presented but not extracted.

No specific P value presented (< 0.05)

Not reported

Not reported

Not reported

Not reported

Not reported

SF‐36: data not presented

Not reported

Not reported

Lavery 2014

Diabetic foot wounds, after incision and drainage
or amputation for infection (surgical lower extremity wounds)

Group A: NPWT with
75 mmHg of pressure with a silicone‐covered dressing (n = 20)

Group B: 125 mmHg of pressure
with a polyurethane foam dressing (n = 20)

4 weeks

NPWT was continued for 4 weeks

Not reported

Not reported

Not reported

Group A: 10/20 (50%)

Group B: 12/20 (60%)

Not reported

Group A: study related 2/20 (10%); non‐study related 1/20 (5%)

Group B: study related 1/20 (5%); non‐study related 1/20 (5%)

Not reported

Not reported

Not reported

Mody 2008

Diabetic foot ulcers

Group A: locally constructed NPWT (n = 6)

Group B: wet‐to‐dry gauze (n = 9)

Not specified: until healing or loss to follow‐up

People receiving TNP only in hospital

Not reported

By secondary intention:

Group A: 1/6 (16.6%)

Group B: 1/9 (11.0%)

Not reported

By delayed primary closure:

Group A: 0/6 (0%)

Group B: 3/9 (33%)

Not reported

Not reported

Not reported

Not reported

Not reported

Nain 2011

Diabetic foot ulcers

Group A: negative pressure dressing (n = 15)
Group B: conventional saline moistened gauze dressing (n = 15)

8 weeks

Ulcers were treated until the wound was closed surgically or spontaneously, or until completion of the 56 days (8 weeks) assessment whichever was earlier.

Not reported

Group A: 12/15 (80%)

Group B: 9/15 (60%)

Not reported

Not reported

Not reported

Not reported

Not reported

Not reported

Not reported

Novinščak 2010

Complicated diabetic foot ulcers

Group A: NPWT (n = 7)

Group B: dressings (moist) (n = 12)

Group C: classic gauze (n = 8)

8 weeks

Treatment was monitored for the first 2 months.

Not reported

Group A: * could not be calculated (90%)

Group B: 9/12* (75%)

Group C: 4/8* (50%)

*Figure calculated by review author

We obtained data (only proportions) from the study author but were unable to use these to calculate number of healed wounds. It seemed this outcome was measured but was not able to use the data in meta‐analysis.

Not reported

Not reported

Not reported

Not reported

Not reported

Not reported

Not reported

Vaidhya 2015

Diabetic foot wound

Group A: NPWT (n = 30)
Group B: saline‐moistened gauze dressing (n = 30)

Not specified

Interventions discontinued for participants in whom failure or complications
occurred

Not reported

Not reported

Data for alternative therapy or amputation:

Group A: 3/30 (10%)

Group B: 7/30 (23.3%)

Wounds were ready for either skin grafting or secondary suturing (end point)

Group A: 27/30 (90%)

Group B: 23/30 (67.7%)

Not reported properly – not all ulcers reached this point

Not reported

Not reported

Limited data: not extracted

Not reported

Zhang 2017

Chronic diabetic ulcers

Group A: vacuum sealing drainage (n = 20)

Group B: gauze dressing (n = 20)

Not reported

Interventions were administered in hospital

Not reported

Group A: 17/20 (85%)

Group B: 13/20 (65%)

Group A: 1/20 (5%)

Group B: 2/20 (10%)

Not reported

Not reported

Not reported

Not reported

Not reported

Not reported

Zhu 2014

Diabetic foot wounds

Group A: vacuum sealing drainage (n = 30)
Group B: traditional treatment (povidone/lipid dressing) (n = 30)

Not reported

Follow‐up to 6–10 months for wounds recurrence

Vacuum sealing drainage administered when necessary at several time points

Not reported properly – not all ulcers healed

Group A: 7/30 (23%)

Group B: 5/30 (17%)

Group A: 0

Group B: 6/30 (20%)

Of healed wounds by secondary surgery (skin/flap grafting):

Group A: 23/30

Group B: 19/24

Not reported properly – not all ulcers reached this point

Not reported

Not reported

Not reported

Group A: 2

Group B: 4

Follow‐up time: 6–10 months

h: hour; IQR: interquartile range; ITT: intention to treat; n: number of participants; NPWT: negative pressure wound therapy; SF‐36: 36‐item Short Form; TNP: topical negative pressure.

Figures and Tables -
Table 1. Study details
Comparison 1. Negative pressure wound therapy (NPWT) compared with dressings in postoperative wounds

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 Proportion of wounds healed Show forest plot

1

162

Risk Ratio (M‐H, Fixed, 95% CI)

1.44 [1.03, 2.01]

2 Time to healing Show forest plot

1

162

Hazard Ratio (Fixed, 95% CI)

1.91 [1.21, 2.99]

3 Amputations Show forest plot

2

292

Risk Ratio (M‐H, Fixed, 95% CI)

0.38 [0.14, 1.02]

4 Number of wounds closed or covered with surgery Show forest plot

1

130

Risk Ratio (M‐H, Fixed, 95% CI)

1.02 [0.95, 1.09]

5 Adverse events Show forest plot

1

162

Risk Ratio (M‐H, Fixed, 95% CI)

0.96 [0.72, 1.28]

Figures and Tables -
Comparison 1. Negative pressure wound therapy (NPWT) compared with dressings in postoperative wounds
Comparison 2. NPWT compared with dressings in diabetic foot ulcers

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 Proportion of wounds healed Show forest plot

5

486

Risk Ratio (IV, Fixed, 95% CI)

1.40 [1.14, 1.72]

1.1 Advanced dressings

1

341

Risk Ratio (IV, Fixed, 95% CI)

1.49 [1.11, 2.01]

1.2 Basic contact dressings

2

45

Risk Ratio (IV, Fixed, 95% CI)

1.34 [0.83, 2.16]

1.3 Anti‐microbial dressings

2

100

Risk Ratio (IV, Fixed, 95% CI)

1.32 [0.93, 1.87]

2 Amputations Show forest plot

3

441

Risk Ratio (M‐H, Fixed, 95% CI)

0.33 [0.15, 0.70]

3 Number of wounds closed or covered with surgery Show forest plot

3

129

Risk Ratio (M‐H, Fixed, 95% CI)

1.02 [0.85, 1.24]

4 Wound recurrence Show forest plot

1

60

Risk Ratio (M‐H, Fixed, 95% CI)

0.5 [0.10, 2.53]

Figures and Tables -
Comparison 2. NPWT compared with dressings in diabetic foot ulcers
Comparison 3. Low compared with high pressure of NPWT in diabetic foot ulcers

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 Number of wounds closed or covered with surgery Show forest plot

1

40

Risk Ratio (M‐H, Fixed, 95% CI)

0.83 [0.47, 1.47]

2 Adverse events Show forest plot

1

40

Risk Ratio (M‐H, Fixed, 95% CI)

1.5 [0.28, 8.04]

Figures and Tables -
Comparison 3. Low compared with high pressure of NPWT in diabetic foot ulcers