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Effects of Hyperbaric Oxygen Therapy on Surgical Wound Healing

NCT01605110 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 164

Last updated 2012-12-05

No results posted yet for this study

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

Conditions

Interventions

DRUG

Hyperbaric oxygen treatment

Patients that volunteer to participate in this study will be exposed to two treatments (one before surgery; one after surgery) of 100% oxygen at 2.0 atmospheres absolute (ATA) inside mono-place chambers for 90 minutes (at depth).

DRUG

Air sham

Patients that volunteer to participate in this study will be exposed to two treatments (one before surgery; one after surgery) of medical grade air (21%oxygen; sham) at 1.2 ATA inside mono-place chambers for 90 minutes.

Sponsors & Collaborators

  • Restorix Research Institute, LLLP

    lead OTHER

Principal Investigators

  • Bryan Sires, MD, FACS · Allure Laser Center & Medispa

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
40 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2011-08-31
Primary Completion
2013-11-30
Completion
2013-12-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01605110 on ClinicalTrials.gov