Hyperbaric Oxygen Therapy - Hyperbaric Chamber Information ...

Summary
The HBO group showed a statistically significantly smaller proportion of failed implants
(p = 0.0009) without a corresponding statistically significant increase in mortality (p =
0.5546). An examination of survival functions supported the difference seen in the crude
proportions (p = 0.0010).
While the study design was lacking in some respects, the result achieved provides some
evidence of the efficacy of HBOT in the treatment of osteoradionecrosis. The generation
of evidence from properly randomised clinical trials that focus on other outcomes will
provide substantial support or refutation of the importance of the effectiveness of
HBOT for this indication.
Skin graft survival
Two studies, dealing with two different procedures – myocutaneous flaps and split skin
grafts, were identified. Both were poorly described. While both indicated they were
randomised controlled trials, neither described their patient populations well, failing to
provide even basic patient descriptions such as age and sex (Table 32).
Table 32 Descriptive characteristics of included studies focusing on the use of HBOT in skin graft
survival.*
First Author and
Year of Publication
Perrins 1967 61
Marx 1995 62
NHMRC
Level
Study
Design
Location
Dates of Characteristics of Study Population
Enrolment Size Age Sex Ratio
II RCT UK ? † 48 ? ?
II RCT US ? 160 ? ?
* Abbreviations: F = female, M = male, RCT = randomised controlled trial
† Unstated, unclear, or unknown.
The earlier study by Perrins 61 used split skin grafts; the Marx 62 study reports the use of
HBO following the application of myocutaneous grafts. Each study is examined
separately below.
Study quality
Study methodology was inadequately described. The methods used to randomise and
mask study participants and outcomes for both studies were unclear (Table 33).
Table 33 Methodological quality of included studies focusing on the use of HBOT in skin graft
survival.*
First Author and
Year of Publication
Study Design Randomisation Masking Losses to Follow-up
Perrins 1967 61 RCT Unclear Single masked No losses
Marx 1995 62 RCT Unclear Unclear No losses
* Abbreviation: RCT = randomised controlled trial
Patient criteria
In the study described by Marx, 62 the subjects recruited into the study required a major
soft tissue surgery or flap after radiation therapy. Perrins61 studied patients presenting for
skin grafts regardless of the underlying cause of the lesion ( Table 34).
Hyperbaric oxygen therapy 41