Edema Clinical Trial
Official title:
Effects of HBOT for Edema/Ecchymosis After Upper Eyelid Blepharoplasty (Single Site Study)
The aim of this study is to test the effect of Hyperbaric Oxygen Therapy) HBOT (100% oxygen;
2.0 ATA; 90 minute total exposure) and compare against a hyperbaric sham treatment (HBST)
(patient's breathing room air; 2.0 ATA; 90 minute exposure) in reducing edema and
ecchymosis. HBOT will be applied as a single pre-operative and a single post-operative
treatment for patients undergoing eyelid surgery. Briefly, patients will be exposed to HBOT
2-4 hours prior to undergoing surgery, 2-4 hours post-surgery and healing will be assessed
at day 3, 10, 21, 30 & 90 days after surgery. Edema and ecchymosis will be assessed in a
time series to determine the extent that HBOT reduces these clinical signs. The primary null
hypothesis to test will be that no differences in scores will exist between treatment and
control at day 3, 10 & 21 post-surgery. A secondary null hypothesis to test is the time
required to change a score will be no different between the two groups.
HBOT=hyperbaric oxygen therapy; HBST=hyperbaric sham treatment
n/a
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Prevention
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