Effects of Hyperbaric Oxygen Therapy on Surgical Wound Healing
Status unconfirmed · Not applicable · Has a placebo group
Conditions studied: Edema, Ecchymosis
In brief
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
Key facts
- Study ID
- NCT01605110
- Run by
- Restorix Research Institute, LLLP
- People needed
- 164
- Starts
- 2011-08-01
- Expected to finish
- 2013-12-01
- Last updated by the study team
- 2012-12-05
Who can join
Age: 40 and older, up to 85. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- Restorix Research Institute — Issaquah, Washington, United States
Full record on ClinicalTrials.gov
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