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Cochrane Database of Systematic Reviews

Apósitos hidrocoloides para la cicatrización de las úlceras del pie diabético

Información

DOI:
https://doi.org/10.1002/14651858.CD009099.pub3Copiar DOI
Base de datos:
  1. Cochrane Database of Systematic Reviews
Versión publicada:
  1. 06 agosto 2013see what's new
Tipo:
  1. Intervention
Etapa:
  1. Review
Grupo Editorial Cochrane:
  1. Grupo Cochrane de Heridas

Copyright:
  1. Copyright © 2013 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.

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Autores

  • Jo C Dumville

    Correspondencia a: Department of Nursing, Midwifery and Social Work, University of Manchester, Manchester, UK

    [email protected]

  • Sohan Deshpande

    Kleijnen Systematic Reviews, York, UK

  • Susan O'Meara

    School of Healthcare, University of Leeds, Leeds, UK

  • Katharine Speak

    York, UK

Contributions of authors

Jo Dumville developed the review and co‐ordinated development, completed the first draft of the review, made an intellectual contribution, approved the final version prior to submission and is the guarantor of the review and the update.
Sohan Deshpande completed the first draft of the review, made an intellectual contribution and approved the final version of the review prior to submission. 
Susan O’Meara edited the review, made an intellectual contribution and approved the final version of the review and the update prior to submission.
Katharine Speak made an intellectual contribution to the review, advised on the review and approved the final version prior to submission.

Contributions of editorial base:

Nicky Cullum: edited the protocol and review; advised on methodology, interpretation and content. Approved the final review prior to submission.
Joan Webster, Editor: approved the review update prior to submission.
Sally Bell‐Syer: co‐ordinated the editorial process. Advised on methodology, interpretation and content. Edited the review.
Ruth Foxlee: designed the search strategy and edited the search methods section.

Sources of support

Internal sources

  • Department of Health Sciences, University of York, UK.

External sources

  • NIHR Programme Grants for Applied Research, UK.

  • NIHR/Department of Health (England), Cochrane Wounds Group, UK.

Declarations of interest

Susan O'Meara and Jo Dumville receive funding from the National Institute for Health Research (NIHR) under its Programme Grants for Applied Research programme. This study presents independent research funded by the National Institute for Health Research (NIHR) under its Programme Grants for Applied Research programme (RP‐PG‐0407‐10428). The views expressed in this presentation are those of the author(s) and not necessarily those of the NHS, the NIHR or the Department of Health.

Sohan Deshpande and Katharine Speak: none declared.

Acknowledgements

The authors would like to thank the following people who reviewed the protocol and review for clarity, readability and rigour: Wounds Group editors (Julie Bruce, Andrea Nelson and Gill Worthy) and peer referees (David Armstrong, Duncan Chambers and Janet Yarrow). In addition copy editor Jenny Bellorini; Nikki Stubbs for clinical advice; Xun Li Xun for translation of Chinese language papers. We would like to thank Sally E.M. Bell‐Syer and Ruth Foxlee for all their expertise and support during the review process.

Version history

Published

Title

Stage

Authors

Version

2013 Aug 06

Hydrocolloid dressings for healing diabetic foot ulcers

Review

Jo C Dumville, Sohan Deshpande, Susan O'Meara, Katharine Speak

https://doi.org/10.1002/14651858.CD009099.pub3

2012 Feb 15

Hydrocolloid dressings for healing diabetic foot ulcers

Review

Jo C Dumville, Sohan Deshpande, Susan O'Meara, Katharine Speak

https://doi.org/10.1002/14651858.CD009099.pub2

2011 May 11

Hydrocolloid dressings for healing diabetic foot ulcers

Protocol

Jo C Dumville, Sohan Deshpande, Susan O'Meara, Katharine Speak

https://doi.org/10.1002/14651858.CD009099

Keywords

MeSH

Medical Subject Headings Check Words

Humans;

'Risk of bias' graph: review authors' judgements about each risk of bias item presented as percentages across all included studies.
Figuras y tablas -
Figure 1

'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.
Figuras y tablas -
Figure 2

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

Comparison 1 Fibrous‐hydrocolloid (hydrofibre) dressing compared with basic wound contact dressing, Outcome 1 Number of ulcers healed.
Figuras y tablas -
Analysis 1.1

Comparison 1 Fibrous‐hydrocolloid (hydrofibre) dressing compared with basic wound contact dressing, Outcome 1 Number of ulcers healed.

Comparison 2 Hydrocolloid (matrix) dressing compared with foam dressing, Outcome 1 Number of ulcers healed.
Figuras y tablas -
Analysis 2.1

Comparison 2 Hydrocolloid (matrix) dressing compared with foam dressing, Outcome 1 Number of ulcers healed.

Comparison 3 Silver hydrocolloid dressing compared with alginate dressing, Outcome 1 Number of ulcers healed.
Figuras y tablas -
Analysis 3.1

Comparison 3 Silver hydrocolloid dressing compared with alginate dressing, Outcome 1 Number of ulcers healed.

Comparison 4 Iodine‐impregnated dressing compared with fibrous‐hydrocolloid (hydrofibre) dressing, Outcome 1 Number of ulcers healed.
Figuras y tablas -
Analysis 4.1

Comparison 4 Iodine‐impregnated dressing compared with fibrous‐hydrocolloid (hydrofibre) dressing, Outcome 1 Number of ulcers healed.

Study

Groups

Primary outcome: ulcer healing

Secondary: health‐related quality of life

Number and level of amputations

Adverse events, including pain

Cost

Ulcer recurrence

Heading 8

Clever 1995

Group A (n = 20): Hydrocolloid (polyurethane matrix) dressing

Group B (n = 20): Foam dressing

Number of ulcers healed:
Group A: 16

Group B: 14
Mean time to healing in days (SD)
Group A: 25.19 (23.52)

Group B: 20.43 (14.74)
Median time to healing in days
Group A: 15.5 (range 4 to 76)

Group B: 16.5 (range 4 to 52)
Wound size at 4 weeks mm2 (SD):
Group A: 32.37 (54.12)

Group B: 33.46 (75.22)

n/r

n/r

(Reasons not reported separately for 2 groups):
Group A: 1

Group B: 5

Mean number of dressing changes between clinical visits (SD):
Group A: 2.23 (2.19)

Group B: 2.37 (2.18)

n/r

Jeffcoate 2009

Group A (n = 103): Fibrous‐hydrocolloid

(hydrofibre) dressing

Group B (n = 108): Iodine‐impregnated dressing
Group C (n = 106): non‐adherent dressing, viscose filament gauze

Number of ulcers healed at 24 weeks:
Group A: 46

Group B: 48
Group C: 41
Mean time to healing in days (SD) (fixed at max of 168 days)
Group A: 125.8 (55.9)

Group B: 127.8 (54.2)
Group C  130.7 (52.4)

Mean Cardiff Wound Impact Schedule score at 24 weeks (SD)

Group A: Physical functioning: 71.4 (19.5).  Social functioning: 70.3 (25.4). Well being: 53.1 (19.9)
Group B: Physical functioning: 67.1 (23.6).  Social functioning: 69.7 (24.1). Well being: 51.0 (22.3) 
Group C: Physical functioning: 68.9 (19.1).  Social functioning: 69.8 (23.5). Well being: 50.2 (21.1) 
Other
Study also reports mean and SD for each of the eight domains of the SF‐36. No significant different between the groups for any domain.

Minor amputations (Below ankle):
Group A: 3
Group B: 1
Group C: 1
Major amputations (Above knee)
Group A: 1
Group B: 0
Group C: 1

Non‐serious adverse events
Group A: 227

Group B: 239
Group C: 244
Serious adverse events
Group A: 28

Group B: 37
Group C: 35

Cost in GBP per patient for dressing management:
Mean (95% CI)

Group A: 191.33 (148.41 to 234.25)
Group B: 183.60 (128.92 to 238.21)
Group C: 141.18 (108.18 to 174.17)
Cost in GBP of professional time in managing foot ulcers: Mean (95% CI)

Group A: 459.87 (354.78 to 564.97)
Group B: 556.90 (422.32 to 691.48)
Group C: 448.86 (348.68 to 549.03
Cost in GBP of generating a healed ulcer using non‐adherent dressing (Group C): 362.

Cost in GBP of generating an additional healed ulcer:

Group A: 836

Group B: 848

At same site
Group A: 3
Group B: 7
Group C: 3

Jude 2007

Group A (n = 67): Fibrous‐hydrocolloid (hydrofibre) dressing with 1.2% ionic silver  
Group B (n = 67): Calcium‐alginate dressing

Number of ulcers healed in 8 weeks
Group A: 21
Group B: 15
Velocity of healing cm2/week (SD):
Group A: 0.29 (0.33) (n = 61)
Group B: 0.26 (0.90) (n = 61)
Velocity of healing as % per week (SD):
Group A: 11.6 (17.7) (n = 61)   
Group B: 10.0 (15.5)  (n = 61)                 
Mean time in days to healing (SD):
Group A: 52.6 (1.8)       
Group B: 57.7 (1.7)                                                                
Reduction in ulcer area in 8 weeks:
Group A: 58.1 (53.1).
Group B: 60.5 (42.7). 
Reduction in ulcer depth (cm) at 8 weeks (SD):
Group A:  0.25 (0.49)   
Group B:  0.13 (0.37)   


                              

n/r

n/r

Group A: 25 participants experienced one or more events. Death = 1; Infection = 14. 8 participants discontinued treatment due to AE.                                            
Group B: 26 participants experienced adverse event. Death = 1; Infection = 8. 13 participants discontinued treatment due to AE.                 

Mean number of dressing changes during study:
Group A: 21.9    
Group B: 20.8   

n/r

Kuo 2012

Group A (n = 12): fibrous‐hydrocolloid (hydrofibre) dressing
Group B (n = 12): cream contained extracts from two botanical raw materials, P. amboinicus and C. asiatica.

Percent change in wound size (from baseline ‐ assumed to 14 days).

Median and (IQR)

Group A: ‐22.64 (‐36.90 to ‐3.20)

Group B: ‐ 27.18(‐38.86 to 36.10)

Reported in paper as not statistically significant from Mann‐Whitney U test. P = 0.673

n/r

n/r

Number of people with one or more adverse events

Group A: 5/12 (41.7%)

Group B: 5/12 (41.7%)

Piaggesi 2001

Group A (n = 10): Fibrous‐hydrocolloid

(hydrofibre) dressing
Group B (n = 10): Saline‐moistened gauze dressing

Number of ulcers healed (during period of study):
Group A: 9
Group B: 10
Healing time in days (mean) (SD)
Group A: 127 (46 days)
Group B: 234 (61 days) 
Median % reduction in lesion volume at 8 weeks follow up (interquartile range):
Group A: 50 (26)           
Group B: 35 (15) 
Median % of granulation tissue at 8 weeks follow up (interquartile range)
Group A: 60 (40)               
Group B: 32.5 (10)                       

    

n/r

Group A: Amputation of a lesser toe = 3; Amputation of 2 lesser toes = 1; Metatarsal resection = 1
Group B: Amputation of a lesser toe = 2; Metatarsal resection = 1

Group A: Maceration of peri‐lesional skin = 1; Infective complications = 1
Group B: Maceration of peri‐lesional skin = 2; Infective complications = 3    

Average number of days between dressings changes (SD)
Group A: 2.1 (0.6)
Group B: 2.4 (0.3)

n/r

Figuras y tablas -
Analysis 5.1

Comparison 5 Trial data, Outcome 1 Trial data.

Summary of findings for the main comparison. Fibrous‐hydrocolloid (hydrofibre) dressing compared to basic wound contact dressing for healing diabetic foot ulcers

Fibrous‐hydrocolloid (hydrofibre) dressing compared to basic wound contact dressing for healing diabetic foot ulcers

Patient or population: patients with healing diabetic foot ulcers
Settings: Any
Intervention: Fibrous‐hydrocolloid (hydrofibre) dressing
Comparison: basic wound contact dressing

Outcomes

Illustrative comparative risks* (95% CI)

Relative effect
(95% CI)

No of Participants
(studies)

Quality of the evidence
(GRADE)

Comments

Assumed risk

Corresponding risk

Basic wound contact dressing

Fibrous‐hydrocolloid (hydrofibre) dressing

Number of ulcers healed

Low1

RR 1.01
(0.74 to 1.38)

229
(2 studies)

⊕⊕⊕⊝
moderate2

340 per 1000

343 per 1000
(252 to 469)

Moderate1

530 per 1000

535 per 1000
(392 to 731)

High1

650 per 1000

657 per 1000
(481 to 897)

HRQoL

See comment

See comment

Not estimable

0
(0)

See comment

One study measured HRQoL at 24 weeks follow‐up. Data from several domains are presented in the report, with no statistically significant difference observed.

Adverse events

See comment

See comment

Not estimable

0
(0)

See comment

AEs for two studies ‐ very similar numbers in each arms. Data not analysed here as not independent ‐ that is one person could have multiple events or due to limited data.

*The basis for the assumed risk (e.g. the median control group risk across studies) is provided in footnotes. The corresponding risk (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; RR: Risk ratio;

GRADE Working Group grades of evidence
High quality: Further research is very unlikely to change our confidence in the estimate of effect.
Moderate quality: Further research is likely to have an important impact on our confidence in the estimate of effect and may change the estimate.
Low quality: Further research is very likely to have an important impact on our confidence in the estimate of effect and is likely to change the estimate.
Very low quality: We are very uncertain about the estimate.

1 Baseline risk of healing obtained from external source in which data from 27,630 patients with a diabetic neuropathic foot ulcer was used to develop a simple prognostic model to predict likelihood of ulcer healing (Margolis DJ, Allen‐Taylor L, Hoffstad O, Berlin JA. Diabetic neuropathic foot ulcers: predicting which ones will not heal. Am J Med. 2003;115:627‐31). It is important to note that given an outcome of ulcer healing, low risk refers to a low risk of healing and thus reflects the most severe patient populations. Conversely high risk refers to a high risk of healing.
2 108 participants achieved the endpoint of healing in the two studies, this is an underpowered comparison. The confidence interval around the estimate of relative risk is consistent with a 26% relative reduction in healing with hydrocolloid and a 38% relative increase in healing with hydrocolloid.

Figuras y tablas -
Summary of findings for the main comparison. Fibrous‐hydrocolloid (hydrofibre) dressing compared to basic wound contact dressing for healing diabetic foot ulcers
Table 1. Summary of studies

First author

Group A

Group B

Group C

Duration of follow up

% healed data

Clever 1995

Hydrocolloid (polyurethane matrix) dressing (Cutinova Hydro, S&N Hlth)

Foam dressing (Allevyn, S&N Hlth)

16 weeks

yes

Jeffcoate 2009

Fibrous‐hydrocolloid (hydrofibre) dressing (Aquacel, ConvaTec)

Iodine‐impregnated dressing (Inadine, Johnson & Johnson)

Non‐adherent dressing (Johnson & Johnson)

24 weeks

yes

Jude 2007

Fibrous‐hydrocolloid (hydrofibre) dressing with 1.2% ionic silver (Aquacel Ag, ConvaTec)

Calcium‐alginate dressing (Algosteril, S&N Hlth)

8 weeks

yes

Kuo 2012

Fibrous‐hydrocolloid (hydrofibre) dressing (Aquacel, ConvaTec)

Cream contained extracts from two botanical raw materials, P. amboinicus and C. asiatica.(Active ingredient 1.25%)

2 weeks

No

Piaggesi 2001

Fibrous‐hydrocolloid (Hydrofibre) dressing (Aquacel, ConvaTec)

Saline‐moistened gauze

Not reported (maximum follow up was 350 days)

yes

Figuras y tablas -
Table 1. Summary of studies
Comparison 1. Fibrous‐hydrocolloid (hydrofibre) dressing compared with basic wound contact dressing

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 Number of ulcers healed Show forest plot

2

229

Risk Ratio (M‐H, Random, 95% CI)

1.01 [0.74, 1.38]

Figuras y tablas -
Comparison 1. Fibrous‐hydrocolloid (hydrofibre) dressing compared with basic wound contact dressing
Comparison 2. Hydrocolloid (matrix) dressing compared with foam dressing

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 Number of ulcers healed Show forest plot

1

Risk Ratio (M‐H, Fixed, 95% CI)

Subtotals only

Figuras y tablas -
Comparison 2. Hydrocolloid (matrix) dressing compared with foam dressing
Comparison 3. Silver hydrocolloid dressing compared with alginate dressing

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 Number of ulcers healed Show forest plot

1

Risk Ratio (M‐H, Fixed, 95% CI)

Subtotals only

Figuras y tablas -
Comparison 3. Silver hydrocolloid dressing compared with alginate dressing
Comparison 4. Iodine‐impregnated dressing compared with fibrous‐hydrocolloid (hydrofibre) dressing

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 Number of ulcers healed Show forest plot

1

Risk Ratio (M‐H, Fixed, 95% CI)

Subtotals only

Figuras y tablas -
Comparison 4. Iodine‐impregnated dressing compared with fibrous‐hydrocolloid (hydrofibre) dressing
Comparison 5. Trial data

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 Trial data Show forest plot

Other data

No numeric data

Figuras y tablas -
Comparison 5. Trial data