Clinical Trial: Effects of Hyperbaric Oxygen Therapy on Surgical Wound Healing

Study Status: Completed
Recruit Status: Unknown status
Study Type: Interventional

Official Title: Effects of HBOT for Edema/Ecchymosis After Upper Eyelid Blepharoplasty (Single Site Study)

Brief Summary:

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


Detailed Summary:
Sponsor: Restorix Research Institute, LLLP

Current Primary Outcome: A measureable reduction of ecchymosis grade in treatment group vs. control group [ Time Frame: 21 days ]

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.


Original Primary Outcome: Same as current

Current Secondary Outcome: A measureable reduction of edema grade in treatment group vs. control group [ Time Frame: 21 days ]

Edema 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.


Original Secondary Outcome: Same as current

Information By: Restorix Research Institute, LLLP

Dates:
Date Received: September 2, 2011
Date Started: August 2011
Date Completion: December 2013
Last Updated: December 3, 2012
Last Verified: December 2012