Thistlethwaite KR, Finlayson KJ, Cooper PD, Brown B, Bennett MH, Kay G, O'Reilly MT, Edwards HE, et al.
Wound repair and regeneration : official publication of the Wound Healing Society [and] the Eur.... Date of publication 2018 Aug 21;volume ():.
1. Wound Repair Regen. 2018 Aug 21. doi: 10.1111/wrr.12657. [Epub ahead of print]
The effectiveness of hyperbaric oxygen therapy for healing chronic venous leg
ulcers: A randomised, double blind, placebo-controlled trial.
Thistlethwaite KR(1), Finlayson KJ(2), Cooper PD(3)(4), Brown B(5), Bennett
MH(6), Kay G(7), O'Reilly MT(8), Edwards HE(8).
Author information:
(1)Hyperbaric Medicine Service, Royal Brisbane & Women's Hospital, Herston, 4059,
Australia.
(2)School of Nursing, Institute of Health and Biomedical Innovation, Queensland
University of Technology, 60 Musk Avenue, Kelvin Grove, 4059, Australia.
(3)Department of Diving & Hyperbaric Medicine, Royal Hobart Hospital.
(4)School of Medicine, University of Tasmania, GPO Box 1061, Hobart, 7001,
Australia.
(5)Department of Diving & Hyperbaric Medicine, Royal Hobart Hospital, GPO Box
1061, Hobart, 7001, Australia.
(6)Department of Diving and Hyperbaric Medicine, Prince of Wales Hospital,
Sydney; Prince of Wales Medical School, University of NSW, Randwick, NSW, 2031,
Australia.
(7)Wesley Centre for Hyperbaric Medicine, 53/30 Chasely St, Auchenflower, 4066,
Australia.
(8)Occupational Therapy, Central Queensland University, University Drive, Faculty
of Health, Queensland University of Technology, George Street, Bundaberg, Qld,
4670, Brisbane, 4000, Australia.
Over 30% of venous leg ulcers do not heal despite evidence-based treatment. This
study aimed to determine the effectiveness of Hyperbaric Oxygen Therapy (HBOT) as
an adjunct treatment for non-healing venous leg ulcers. A randomised,
double-blind, parallel group, placebo-controlled trial was undertaken in three
hyperbaric medicine units. Adults with a venous leg ulcer, Transcutaneous Oxygen
Measurement indicative of a hypoxic wound responsive to oxygen challenge, and
without contraindications for HBOT; were eligible. Of 84 eligible patients, 10
refused and 74 enrolled. 43 participants achieved over 50% ulcer Percent Area
Reduction (PAR) after four weeks of evidence-based care and were thus excluded
from the intervention phase. Thirty-one participants were randomised to either 30
HBOT treatments (100% oxygen at 2·4 atmospheres absolute (ATA) for 80 minutes),
or 30 "placebo" treatments, receiving a validated 'sham' air protocol, initially
pressurised to 1.2ATA, then cycled between 1.05-1.2ATA for eight minutes before
settling at 1.05ATA. The primary outcome was numbers in each group completely
healed. Secondary outcomes were ulcer PAR, pain and quality of life, 12 weeks
after commencing interventions. The participants' mean age was 70 years (Standard
Deviation (SD) 12·9) and median ulcer duration at enrolment was 62 weeks (range
4-3120). At 12 weeks, there was no significant difference between groups in the
numbers completely healed. The HBOT intervention group had a mean of 95 (SD 6.53)
ulcer PAR, compared to 54 (SD 67.8) mean PAR for the placebo group (t = -2·24,
p=0·042, mean difference -40·8, SE 18·2) at 12 weeks. HBOT may improve refractory
healing in venous leg ulcers, however patient selection is important. In this
study, HBOT as an adjunct treatment for non-healing patients returned indolent
ulcers to a healing trajectory. This article is protected by copyright. All
rights reserved.
This article is protected by copyright. All rights reserved.
DOI: 10.1111/wrr.12657
PMID: 30129080