^Thistlethwaite

The addition of hyperbaric oxygen did not improve the chance of venous ulcer healing at 12 weeks

Clinical Bottom Line:

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1. There was no important difference in the proportion of ulcers healed with the addition of HBOT

2. The trajectory of healing was improved with HBOT

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Citation/s:1. Thistlethwaite KR, Finlayson KJ, Cooper PD, Brown B, Bennett MH, Kay G, O'Reilly MT, Edwards HE. The effectiveness of hyperbaric oxygen therapy for healing chronic venous leg ulcers: A randomized, double-blind, placebo-controlled trial. Wound Repair and Regeneration. 2018 Jul;26(4):324-31.

2. Thistlethwaite KR, Finlayson KJ, Cooper PD, Brown B, Bennett MH, Kay G, O'Reilly MT, Edwards HE. The Effectiveness of Hyperbaric Oxygen Therapy for Healing Chronic Venous Leg Ulcers: A Randomized, Double-Blind, Placebo-Controlled Trial. Journal of Vascular Surgery: Venous and Lymphatic Disorders. 2019 May 1;7(3):466.

Lead author's name: Kathleen Finlayson k.finlayson@qut.edu.au

Three-part Clinical Question:For patients with chronic venous ulcer, does the addition of hyperbaric oxygen therapy to standard wound care measurements, result in improved healing?

Search Terms:venous ulcer; lower limb; chronic wound

The Study:Double-blinded concealed randomised controlled trial with intention-to-treat.

The Study Patients:  Adult patients with venous ulcers where there was less than 50% healing over a four-week standardised wound dressing regimen period. No evidence of gross arterial insufficiency.

Control group(N = 15; 15 analysed): Standard wound care including dressings and compression bandaging. Sham treatment breathing air at trivial pressure for 80 minutes daily to a total of 30 sessions or ulcer healing..

Experimental group(N = 14; 14 analysed): As above, but 100% oxygen breathing at 2.4 ATA on the same schedule as above.

 

The Evidence:

Outcome	Time to outcome	Sham Group	HBOT Group	Relative Risk Reduction	Absolute Risk Reduction	NNT
Complete healing	12 weeks	0.4	0.36	11%	0.04	23
95%CI:				-77% to 99%	-0.31 to 0.40	NNT = 3 to INF;  NNH = 3 to INF

 

Measure	Sham Group		HBO Group		Difference	95%CI
	Mean	SD	Mean	SD
Percent area reduction at 12 weeks	54	67.8	95	6.53	41	35.6 to 72.4
Pain score at 12 weeks (0 to 100)	35.9	23.4	26.4	18.4	9.5	-331 to 350

   Comments:

1. 30 of 61 (49%) of those enrolled had more than 50% reduction in ulcer size during the 4 week 'wash-in' period and were not randomised. Expected rate from literature was 30%.
2. Study was powered to find a 50% healing rate with HBOT compared to 30% in the wound care only group - grossly underpowered due to slow recruitment.
3. The HBOT group had significantly poorer physical health-related QoL scores than the sham group. There were three outliers with ulcer areas greater than 75cm², all three in the HBOT group. Bias likely away from the effectiveness of HBOT.
4. Undertaking a PP analysis of the proportion of participants in each group healed at 12 weeks, 36% (5/14) of the sham group, and 46% (5/11) of the HBOT group fully healed (9.8% better with HBOT, 95%CI -26% to 49%).
5. The Pressure Ulcer Scale for Healing (PUSH) scores were generally better with HBOT but did not reach statistical significance.
6. This CAT done by one of the authors. Independent review encouraged please!
  
Appraised by:Mike Bennett m.bennett@unsw.edu.au; Friday, 2 October 2020

Kill or Update By:  October 2021

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