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.
The
Evidence:
|
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 2004
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.
