Hyperbaric oxygen therapy for chronic wounds

Peter Kranke; Michael H Bennett; Marrissa Martyn‐St James; Alexander Schnabel; Sebastian E Debus; Stephanie Weibel

doi:10.1002/14651858.CD004123.pub4

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Figure 1

Methodological quality summary: review authors' judgements about each methodological quality item for each included study.

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Analysis 1.1

Comparison 1 Diabetic ulcers, Outcome 1 Healed at end of treatment (6 weeks).

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Analysis 1.2

Comparison 1 Diabetic ulcers, Outcome 2 Healed at end of treatment. Best‐case..

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Analysis 1.3

Comparison 1 Diabetic ulcers, Outcome 3 Healed at end of treatment. Worst‐case..

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Analysis 1.4

Comparison 1 Diabetic ulcers, Outcome 4 Healed at 6 months.

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Analysis 1.5

Comparison 1 Diabetic ulcers, Outcome 5 Healed at 6 months. Best‐case..

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Analysis 1.6

Comparison 1 Diabetic ulcers, Outcome 6 Healed at 6 months. Worst‐case..

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Analysis 1.7

Comparison 1 Diabetic ulcers, Outcome 7 Healed at 1 year.

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Analysis 1.8

Comparison 1 Diabetic ulcers, Outcome 8 Healed at 1 year. Peto analysis method..

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Analysis 1.9

Comparison 1 Diabetic ulcers, Outcome 9 Healed at 1 year. Best‐case..

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Analysis 1.10

Comparison 1 Diabetic ulcers, Outcome 10 Healed at 1 year. Worst‐case..

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Analysis 1.11

Comparison 1 Diabetic ulcers, Outcome 11 Major amputations.

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Analysis 1.12

Comparison 1 Diabetic ulcers, Outcome 12 Major amputations. Best‐case..

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Analysis 1.13

Comparison 1 Diabetic ulcers, Outcome 13 Major amputations. Worst‐case..

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Analysis 1.14

Comparison 1 Diabetic ulcers, Outcome 14 Major amputation subgroup by use of sham.

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Analysis 1.15

Comparison 1 Diabetic ulcers, Outcome 15 Minor amputations.

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Analysis 1.16

Comparison 1 Diabetic ulcers, Outcome 16 Minor amputations. Best‐case..

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Analysis 1.17

Comparison 1 Diabetic ulcers, Outcome 17 Minor amputations. Worst‐case..

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Analysis 1.18

Comparison 1 Diabetic ulcers, Outcome 18 Transcutaneous oxygen tensions change after treatment.

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Analysis 1.19

Comparison 1 Diabetic ulcers, Outcome 19 Absolute difference in transcutaneous oxygen at end of treatment.

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Analysis 1.20

Comparison 1 Diabetic ulcers, Outcome 20 Ulcer area reduction (%).

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Analysis 1.21

Comparison 1 Diabetic ulcers, Outcome 21 Quality of life ‐ SF‐36 physical summary score.

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Analysis 1.22

Comparison 1 Diabetic ulcers, Outcome 22 Quality of life ‐ SF‐36 mental summary score.

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Analysis 2.1

Comparison 2 Venous ulcers, Outcome 1 Healed at 18 weeks.

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Analysis 2.2

Comparison 2 Venous ulcers, Outcome 2 Healed at 18 weeks. Best‐case..

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Analysis 2.3

Comparison 2 Venous ulcers, Outcome 3 Healed at 18 weeks. Worst‐case..

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Analysis 2.4

Comparison 2 Venous ulcers, Outcome 4 Wound size reduction at end treatment (6 weeks).

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Analysis 2.5

Comparison 2 Venous ulcers, Outcome 5 Wound size reduction at 18 weeks.

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Analysis 3.1

Comparison 3 Mixed ulcers types, Outcome 1 Healed at end of treatment (30 days).

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Analysis 3.2

Comparison 3 Mixed ulcers types, Outcome 2 Major amputations.

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Analysis 3.3

Comparison 3 Mixed ulcers types, Outcome 3 Periwound transcutaneous oxygen tensions at the end of treatment.

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Analysis 3.4

Comparison 3 Mixed ulcers types, Outcome 4 Ulcer area reduction (%).

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Summary of findings for the main comparison. Hyperbaric Oxygen Therapy for chronic wounds

Hyperbaric Oxygen Therapy for chronic wounds
Patient or population: patients with chronic wounds Settings: inpatients and outpatients in a hyperbaric facility Intervention: Hyperbaric Oxygen Therapy
Outcomes	*Illustrative comparative risks (95% CI)**		Relative effect (95% CI)	No of Participants (studies)	Quality of the evidence (GRADE)	Comments
	Assumed risk	Corresponding risk
	Control	Hyperbaric Oxygen Therapy
Diabetic ulcers healed at 1 year. Follow‐up: 1 years	Study population		RR 9.53 (0.44 to 207.76)	212 (3 studies)	⊕⊕⊕⊝ moderate^1,2,3
	115 per 1000	1000 per 1000 (51 to 1000)
	Low
	0 per 1000	0 per 1000 (0 to 0)
	High
	0 per 1000	0 per 1000 (0 to 0)
Diabetic ulcers ‐ major amputations	Study population		RR 0.36 (0.11 to 1.18)	312 (5 studies)	⊕⊕⊕⊝ moderate²
	247 per 1000	89 per 1000 (27 to 284)
	Low
	0 per 1000	0 per 1000 (0 to 0)
	High
	0 per 1000	0 per 1000 (0 to 0)
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 Analysis comprises small studies, some with zero events in control arm ² small sample size ³ very large effect: RR >5

Summary of findings for the main comparison. Hyperbaric Oxygen Therapy for chronic wounds

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Table 1. Patients missing from final follow‐up

Study	Missing but included	Missing total	Per cent of entered
Khandelwal 2013	0	11	28%
Kaur 2012	0	0	0
Ma 2013	0	0	0
Doctor 1992	0	0	0
Faglia 1996a	0	2	3%
Lin 2001	0	0	0
Abidia 2003	0	2	11%
Hammarlund 1994	0	5	31%
Kessler 2003	0	1	<1%
Duzgun 2008	0	0	0
Londahl 2010	19	19	12% ‐ included in ITT
Wang 2011	0	9	10%
ITT: intention‐to‐treat

Table 1. Patients missing from final follow‐up

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Comparison 1. Diabetic ulcers

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Healed at end of treatment (6 weeks) Show forest plot	5	205	Risk Ratio (M‐H, Fixed, 95% CI)	2.35 [1.19, 4.62]

2 Healed at end of treatment. Best‐case. Show forest plot	5	216	Risk Ratio (M‐H, Fixed, 95% CI)	4.61 [2.35, 9.08]

3 Healed at end of treatment. Worst‐case. Show forest plot	5	216	Risk Ratio (M‐H, Fixed, 95% CI)	0.84 [0.51, 1.37]

4 Healed at 6 months Show forest plot	2	112	Risk Ratio (M‐H, Fixed, 95% CI)	1.70 [0.90, 3.20]

5 Healed at 6 months. Best‐case. Show forest plot	2	112	Risk Ratio (M‐H, Fixed, 95% CI)	2.71 [1.53, 4.83]

6 Healed at 6 months. Worst‐case. Show forest plot	2	112	Risk Ratio (M‐H, Fixed, 95% CI)	0.93 [0.57, 1.54]

7 Healed at 1 year Show forest plot	3	212	Risk Ratio (M‐H, Random, 95% CI)	9.53 [0.44, 207.76]

8 Healed at 1 year. Peto analysis method. Show forest plot	3	212	Peto Odds Ratio (Peto, Fixed, 95% CI)	7.58 [4.33, 13.29]

9 Healed at 1 year. Best‐case. Show forest plot	3	212	Risk Ratio (M‐H, Random, 95% CI)	10.17 [0.47, 220.48]

10 Healed at 1 year. Worst‐case. Show forest plot	3	212	Risk Ratio (M‐H, Random, 95% CI)	6.55 [0.42, 101.71]

11 Major amputations Show forest plot	5	312	Risk Ratio (M‐H, Random, 95% CI)	0.36 [0.11, 1.18]

11.1 Subgroup (30+ treatments)	4	282	Risk Ratio (M‐H, Random, 95% CI)	0.40 [0.07, 2.23]
11.2 Subgroup (< 30 treatments)	1	30	Risk Ratio (M‐H, Random, 95% CI)	0.29 [0.07, 1.16]
12 Major amputations. Best‐case. Show forest plot	5	312	Risk Ratio (M‐H, Fixed, 95% CI)	0.20 [0.10, 0.38]

13 Major amputations. Worst‐case. Show forest plot	5	312	Risk Ratio (M‐H, Random, 95% CI)	0.62 [0.13, 2.98]

14 Major amputation subgroup by use of sham Show forest plot	5		Risk Ratio (M‐H, Fixed, 95% CI)	Subtotals only

14.1 Sham HBOT	2	112	Risk Ratio (M‐H, Fixed, 95% CI)	0.47 [0.09, 2.44]
14.2 No sham	3	200	Risk Ratio (M‐H, Fixed, 95% CI)	0.15 [0.06, 0.36]
15 Minor amputations Show forest plot	4	242	Risk Ratio (M‐H, Random, 95% CI)	0.76 [0.19, 3.10]

16 Minor amputations. Best‐case. Show forest plot	4	242	Risk Ratio (M‐H, Random, 95% CI)	0.55 [0.17, 1.75]

17 Minor amputations. Worst‐case. Show forest plot	4	242	Risk Ratio (M‐H, Random, 95% CI)	0.91 [0.21, 4.02]

18 Transcutaneous oxygen tensions change after treatment Show forest plot	1	68	Mean Difference (IV, Fixed, 95% CI)	9.0 [4.68, 13.32]

19 Absolute difference in transcutaneous oxygen at end of treatment Show forest plot	3	113	Mean Difference (IV, Fixed, 95% CI)	11.76 [5.68, 17.84]

20 Ulcer area reduction (%) Show forest plot	2	63	Mean Difference (IV, Random, 95% CI)	18.10 [1.40, 34.79]

21 Quality of life ‐ SF‐36 physical summary score Show forest plot	1	33	Mean Difference (IV, Fixed, 95% CI)	‐0.20 [‐8.58, 8.18]

22 Quality of life ‐ SF‐36 mental summary score Show forest plot	1	33	Mean Difference (IV, Fixed, 95% CI)	6.60 [‐3.93, 17.13]

Comparison 1. Diabetic ulcers

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Comparison 2. Venous ulcers

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Healed at 18 weeks Show forest plot	1	16	Risk Ratio (M‐H, Fixed, 95% CI)	5.0 [0.28, 90.18]

2 Healed at 18 weeks. Best‐case. Show forest plot	1	16	Risk Ratio (M‐H, Fixed, 95% CI)	9.0 [0.56, 143.89]

3 Healed at 18 weeks. Worst‐case. Show forest plot	1	16	Risk Ratio (M‐H, Fixed, 95% CI)	0.67 [0.15, 2.98]

4 Wound size reduction at end treatment (6 weeks) Show forest plot	1	16	Mean Difference (IV, Fixed, 95% CI)	33.0 [18.97, 47.03]

5 Wound size reduction at 18 weeks Show forest plot	1	11	Mean Difference (IV, Fixed, 95% CI)	29.60 [‐22.99, 82.19]

Comparison 2. Venous ulcers

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Comparison 3. Mixed ulcers types

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Healed at end of treatment (30 days) Show forest plot	1	30	Risk Ratio (M‐H, Fixed, 95% CI)	7.0 [0.39, 124.83]

2 Major amputations Show forest plot	1	30	Risk Ratio (M‐H, Fixed, 95% CI)	0.2 [0.03, 1.51]

3 Periwound transcutaneous oxygen tensions at the end of treatment Show forest plot	1	30	Mean Difference (IV, Fixed, 95% CI)	12.90 [4.00, 21.80]

4 Ulcer area reduction (%) Show forest plot	1	30	Mean Difference (IV, Fixed, 95% CI)	61.88 [41.91, 81.85]

Comparison 3. Mixed ulcers types

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