The effectiveness of hyperbaric oxygen therapy for healing chronic venous leg ulcers: A randomized, double-blind, placebo-controlled trial.

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 nonhealing venous leg ulcers. A randomized, 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 randomized 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 pressurized 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 nonhealing patients returned indolent ulcers to a healing trajectory.

Performance of the Baxter Infusor LV10 under hyperbaric conditions.

INTRODUCTION: Elastomeric drug delivery devices are a simple way to provide long-term IV therapy to patients in the outpatient setting. Patients receiving hyperbaric oxygen therapy occasionally need these devices. This study compared the performance of the Baxter infusor LV10 elastomeric device in repetitive conditions at pressures of 101.3 kPa and 243 kPa. METHODS: Ten Baxter infusor LV10 elastomeric devices were pressurised in a hyperbaric chamber to 243 kPa over a two-hour period consistent with a standard medical treatment run. This process was repeated 10 times for each device giving a total of 20 hours under pressure. The fluid delivered by each device was measured and the device weighed at the end of each pressurisation. Ten control devices containing identical drugs were tested in the same manner at 101.3 kPa over the same time period. RESULTS: No significant differences in output of the devices were observed between hyperbaric and control conditions. The flow rates measured in both study groups were 35% lower than the manufacturer's stated flow rate, possibly due to lower test environment temperature and outdated devices used in the tests. CONCLUSION: Despite lower than expected flow rates, this study demonstrated no significant difference in the delivery rate of the Baxter infusor LV10 under 243 kPa hyperbaric conditions compared with room pressure.