Sires.
Trial name or title | NCT01605110 Effects of Hyperbaric Oxygen Therapy on Surgical Wound Healing (BLEPH) |
Methods | Randomized controlled trial |
Participants | 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: 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. |
Interventions | Intervention: Hyperbaric oxygen therapy: two HBOT treatments (one before and one after surgery) with patients who have undergone upper eyelid surgery. Patients that volunteer to participate in this study will be exposed to two treatments of 100% oxygen at 2.0 atmospheres absolute (ATA) Comparison: air (sham) 1.2 ATA inside mono‐place chambers for 90 minutes. |
Outcomes | Reduction of ecchymosis grade (Time Frame: 21 days) clinical signs, reduction of edema (Time Frame: 21 days) |
Starting date | August 2011 ‐ Anticipated end date: November 2013 |
Contact information | Bryan Sires, MD, FACS (no email address given), Allure Laser Center & Medispa |
Notes | Location: Washington, USA Source of funding: Restorix Research Institute, LLLP |