Effects of Hyperbaric Oxygen Therapy on Surgical Wound Healing
| Status: | Completed |
|---|---|
| Conditions: | Cardiology, Hematology |
| Therapuetic Areas: | Cardiology / Vascular Diseases, Hematology |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 11/18/2012 |
| Start Date: | August 2011 |
| End Date: | November 2013 |
| Contact: | Bryan Sires, MD |
| Email: | bsires@u.washington.edu |
| Phone: | 425-216-7200 |
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
Inclusion Criteria:
- Patients that are able to undergo surgery at the Allure Clinic are capable of
undergoing exposure to HBOT, as the contraindications of HBOT are similar to eyelid
surgery, with few exceptions.
Exclusion Criteria:
- The investigators will exclude active smokers and those who have quit smoking in the
last 12 months, those with known lung disease, seizure disorder, congestive heart
failure, known active cancer, previous treatment with specific chemotherapy agents
(Doxorubicin, Bleomycin, Disulfiram, Cis-platinum, Mafenide acetate), those who
cannot undergo pressurization/ depressurization because of eustachian-tube
dysfunction and confinement anxiety.
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