The addition of hyperbaric oxygen to the treatment of chronic, non-diabetic leg ulcers resulted in a reduction in wound area.
Clinical Bottom Line: 1. The addition of hyperbaric oxygen was associated with a significant reduction in the area of chronic wounds. 2. No wounds were completely healed at the end of the six week treatment period, but there was a trend to eventual healing in the hyperbaric group. Appraised by: Mike Bennett, Dept. of Diving and Hyperbaric Medicine, Prince of Wales Hospital, Sydney; Sunday, 15 November, 1998
Clinical Scenario: An adult with chronic, non-diabetic leg ulcer in the absence of major arterial/venous vessel disease. Three-part Question: In adult patients with chronic, non-diabetic leg ulcers, does the adjunctive use of hyperbaric oxygenation compared to standard wound care alone, result in any improvement in ulcer size or other signs of healing. Search Terms: Hyperbaric oxygenation, Leg ulcer
The Study: Double-blinded concealed randomised controlled trial with intention-to-treat. Leg ulcer present for one year or longer, no major vascular disorder, non-smoking, non-diabetic. Control group (N = 8; 5 analysed): All treatment prescribed at enrolment was continued. Sham treatment breathing air at 2.5 ATA for 90 minutes daily, 5 days each week to a total of 30 sessions. Experimental group (N = 8; 6 analysed): As above plus addition of hyperbaric oxygenation at 2.5 ATA on the same regime as control group.
|Outcome||Time to Outcome||Control||Hyperbaric||Relative risk reduction||Absolute risk reduction||Number needed to treat|
|Wound healed||18 weeks||0||0.333||INF||0.333||3|
|95% CI||0.71 to 0.04||NNT 23 to INF NNH 1 to INF|
Wound area decrease(%) Air group HBO group P-value week 2 2.8 6.6 ns
week 4 3.7 22.0 <0.05
week 6 2.7 35.7 <0.001
Comments: 1. Data relating to complete healing is unreliable because of loss to follow-up of significant numbers at 18 weeks. 2. Clinical significance of reduction in wound size not evaluated. 3. Small, but well-controlled and concealed by the use of sham treatment sessions.
Expiry date: September 2013 References: 1. Hammarlund C, Sundberg T. Hyperbaric oxygen reduced size of chronic leg ulcers: a randomized double-blind study. Plastic and Reconstructive Surgery 1994; 93:829-834.