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Meta-Analysis
. 2015 Jun 24;2015(6):CD004123.
doi: 10.1002/14651858.CD004123.pub4.

Hyperbaric oxygen therapy for chronic wounds

Peter Kranke  1 , Michael H Bennett, Marrissa Martyn-St James, Alexander Schnabel, Sebastian E Debus, Stephanie Weibel
Affiliations
Meta-Analysis

Hyperbaric oxygen therapy for chronic wounds

Peter Kranke et al. Cochrane Database Syst Rev. .

Abstract

Background: Chronic wounds are common and present a health problem with significant effect on quality of life. Various pathologies may cause tissue breakdown, including poor blood supply resulting in inadequate oxygenation of the wound bed. Hyperbaric oxygen therapy (HBOT) has been suggested to improve oxygen supply to wounds and therefore improve their healing.

Objectives: To assess the benefits and harms of adjunctive HBOT for treating chronic ulcers of the lower limb.

Search methods: For this second update we searched the Cochrane Wounds Group Specialised Register (searched 18 February 2015); the Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library 2015, Issue 1); Ovid MEDLINE (1946 to 17 February 2015); Ovid MEDLINE (In-Process & Other Non-Indexed Citations, 17 February 2015); Ovid EMBASE (1974 to 17 February 2015); and EBSCO CINAHL (1982 to 17 February 2015).

Selection criteria: Randomised controlled trials (RCTs) comparing the effect on chronic wound healing of therapeutic regimens which include HBOT with those that exclude HBOT (with or without sham therapy).

Data collection and analysis: Three review authors independently evaluated the risk of bias of the relevant trials using the Cochrane methodology and extracted the data from the included trials. We resolved any disagreement by discussion.

Main results: We included twelve trials (577 participants). Ten trials (531 participants) enrolled people with a diabetic foot ulcer: pooled data of five trials with 205 participants showed an increase in the rate of ulcer healing (risk ratio (RR) 2.35, 95% confidence interval (CI) 1.19 to 4.62; P = 0.01) with HBOT at six weeks but this benefit was not evident at longer-term follow-up at one year. There was no statistically significant difference in major amputation rate (pooled data of five trials with 312 participants, RR 0.36, 95% CI 0.11 to 1.18). One trial (16 participants) considered venous ulcers and reported data at six weeks (wound size reduction) and 18 weeks (wound size reduction and number of ulcers healed) and suggested a significant benefit of HBOT in terms of reduction in ulcer area only at six weeks (mean difference (MD) 33.00%, 95% CI 18.97 to 47.03, P < 0.00001). We identified one trial (30 participants) which enrolled patients with non-healing diabetic ulcers as well as venous ulcers ("mixed ulcers types") and patients were treated for 30 days. For this "mixed ulcers" there was a significant benefit of HBOT in terms of reduction in ulcer area at the end of treatment (30 days) (MD 61.88%, 95% CI 41.91 to 81.85, P < 0.00001). We did not identify any trials that considered arterial and pressure ulcers.

Authors' conclusions: In people with foot ulcers due to diabetes, HBOT significantly improved the ulcers healed in the short term but not the long term and the trials had various flaws in design and/or reporting that means we are not confident in the results. More trials are needed to properly evaluate HBOT in people with chronic wounds; these trials must be adequately powered and designed to minimise all kinds of bias.

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Conflict of interest statement

Peter Kranke: received consultancy payments from MSD and ProStrakan and payments for consultancy and grants from Fresenius Kabi.

Michael Bennett: none known.

Marissa Martyn‐St James: none known

Alexander Schnabel: none known

Sebastian Debus: none known

Stephanie Weibel: none known

27/02/20 Clarification message from the Co‐ordinating Editors: this review was found by the Cochrane Funding Arbiters, post publication, to be noncompliant with the Cochrane Conflict of Interest policy which includes the relevant parts of the Cochrane Commercial Sponsorship policy. A new update is underway which we expect to be published within 12 months. The update will have a majority of review authors and lead author free of conflicts.

Figures

1
1
Methodological quality summary: review authors' judgements about each methodological quality item for each included study.
1.1
1.1. Analysis
Comparison 1 Diabetic ulcers, Outcome 1 Healed at end of treatment (6 weeks).
1.2
1.2. Analysis
Comparison 1 Diabetic ulcers, Outcome 2 Healed at end of treatment. Best‐case..
1.3
1.3. Analysis
Comparison 1 Diabetic ulcers, Outcome 3 Healed at end of treatment. Worst‐case..
1.4
1.4. Analysis
Comparison 1 Diabetic ulcers, Outcome 4 Healed at 6 months.
1.5
1.5. Analysis
Comparison 1 Diabetic ulcers, Outcome 5 Healed at 6 months. Best‐case..
1.6
1.6. Analysis
Comparison 1 Diabetic ulcers, Outcome 6 Healed at 6 months. Worst‐case..
1.7
1.7. Analysis
Comparison 1 Diabetic ulcers, Outcome 7 Healed at 1 year.
1.8
1.8. Analysis
Comparison 1 Diabetic ulcers, Outcome 8 Healed at 1 year. Peto analysis method..
1.9
1.9. Analysis
Comparison 1 Diabetic ulcers, Outcome 9 Healed at 1 year. Best‐case..
1.10
1.10. Analysis
Comparison 1 Diabetic ulcers, Outcome 10 Healed at 1 year. Worst‐case..
1.11
1.11. Analysis
Comparison 1 Diabetic ulcers, Outcome 11 Major amputations.
1.12
1.12. Analysis
Comparison 1 Diabetic ulcers, Outcome 12 Major amputations. Best‐case..
1.13
1.13. Analysis
Comparison 1 Diabetic ulcers, Outcome 13 Major amputations. Worst‐case..
1.14
1.14. Analysis
Comparison 1 Diabetic ulcers, Outcome 14 Major amputation subgroup by use of sham.
1.15
1.15. Analysis
Comparison 1 Diabetic ulcers, Outcome 15 Minor amputations.
1.16
1.16. Analysis
Comparison 1 Diabetic ulcers, Outcome 16 Minor amputations. Best‐case..
1.17
1.17. Analysis
Comparison 1 Diabetic ulcers, Outcome 17 Minor amputations. Worst‐case..
1.18
1.18. Analysis
Comparison 1 Diabetic ulcers, Outcome 18 Transcutaneous oxygen tensions change after treatment.
1.19
1.19. Analysis
Comparison 1 Diabetic ulcers, Outcome 19 Absolute difference in transcutaneous oxygen at end of treatment.
1.20
1.20. Analysis
Comparison 1 Diabetic ulcers, Outcome 20 Ulcer area reduction (%).
1.21
1.21. Analysis
Comparison 1 Diabetic ulcers, Outcome 21 Quality of life ‐ SF‐36 physical summary score.
1.22
1.22. Analysis
Comparison 1 Diabetic ulcers, Outcome 22 Quality of life ‐ SF‐36 mental summary score.
2.1
2.1. Analysis
Comparison 2 Venous ulcers, Outcome 1 Healed at 18 weeks.
2.2
2.2. Analysis
Comparison 2 Venous ulcers, Outcome 2 Healed at 18 weeks. Best‐case..
2.3
2.3. Analysis
Comparison 2 Venous ulcers, Outcome 3 Healed at 18 weeks. Worst‐case..
2.4
2.4. Analysis
Comparison 2 Venous ulcers, Outcome 4 Wound size reduction at end treatment (6 weeks).
2.5
2.5. Analysis
Comparison 2 Venous ulcers, Outcome 5 Wound size reduction at 18 weeks.
3.1
3.1. Analysis
Comparison 3 Mixed ulcers types, Outcome 1 Healed at end of treatment (30 days).
3.2
3.2. Analysis
Comparison 3 Mixed ulcers types, Outcome 2 Major amputations.
3.3
3.3. Analysis
Comparison 3 Mixed ulcers types, Outcome 3 Periwound transcutaneous oxygen tensions at the end of treatment.
3.4
3.4. Analysis
Comparison 3 Mixed ulcers types, Outcome 4 Ulcer area reduction (%).
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