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Effects of Hyperbaric Oxygen Therapy on Surgical Wound Healing (BLEPH)

This study is enrolling participants by invitation only.
Sponsor:
Information provided by (Responsible Party):
Restorix Research Institute, LLLP
ClinicalTrials.gov Identifier:
NCT01605110
First received: September 2, 2011
Last updated: December 3, 2012
Last verified: December 2012
History of Changes
  Purpose

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


Condition Intervention
Edema
Ecchymosis
 Drug: Hyperbaric oxygen treatment
Drug: Air sham

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Effects of HBOT for Edema/Ecchymosis After Upper Eyelid Blepharoplasty (Single Site Study)

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Restorix Research Institute, LLLP:

Primary Outcome Measures:
  • A measureable reduction of ecchymosis grade in treatment group vs. control group [ Time Frame: 21 days ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • A measureable reduction of edema grade in treatment group vs. control group [ Time Frame: 21 days ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 164
Study Start Date: August 2011
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: November 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Hyperbaric oxygen therapy
We propose to study the effects of two HBOT treatments (one before and one after surgery) with patients who have undergone upper eyelid surgery. Reduction in swelling and bruising will be assessed at 3, 10, 21, 30 and 90 days post-surgery to determine if healing is accelerated by HBOT. Patients that volunteer to participate in this study will be exposed to two treatments of 100% oxygen at 2.0 atmospheres absolute (ATA) or air (sham) 1.2 ATA inside mono-place chambers for 90 minutes. By comparing oxygen treatment groups with a matched control group, we can accurately assess the effectiveness of this treatment for patients. By participating in this study, patients will help in establishing the best treatment practices of using HBOT to accelerate healing and reduce cost in surgical recovery.
 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).
Sham Comparator: Air sham
We propose to study the effects of two HBOT treatments (one before and one after surgery) with patients who have undergone upper eyelid surgery. Reduction in swelling and bruising will be assessed at 3, 10, 21, 30 and 90 days post-surgery to determine if healing is accelerated by HBOT. Patients that volunteer to participate in this study will be exposed to two treatments of 100% oxygen at 2.0 atmospheres absolute (ATA) or air (sham) 1.2 ATA inside mono-place chambers for 90 minutes. By comparing oxygen treatment groups with a matched control group, we can accurately assess the effectiveness of this treatment for patients. By participating in this study, patients will help in establishing the best treatment practices of using HBOT to accelerate healing and reduce cost in surgical recovery.
 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.

  Eligibility

Ages Eligible for Study:   40 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01605110

Locations
United States, Washington
Restorix Research Institute
Issaquah, Washington, United States, 98027
Sponsors and Collaborators
Restorix Research Institute, LLLP
Investigators
Principal Investigator: Bryan Sires, MD, FACS Allure Laser Center & Medispa
  More Information

No publications provided

Responsible Party: Restorix Research Institute, LLLP
ClinicalTrials.gov Identifier: NCT01605110     History of Changes
Other Study ID Numbers: RRI-2011-02-BLEPH-00 BS
Study First Received: September 2, 2011
Last Updated: December 3, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Restorix Research Institute, LLLP:
blepharoplasty
hyperbaric
oxygen
ecchymosis
 edema
wound
healing

Additional relevant MeSH terms:
Ecchymosis
Edema
Blood Coagulation Disorders
Hematologic Diseases
 Hemorrhage
Pathologic Processes
Skin Manifestations
Signs and Symptoms

ClinicalTrials.gov processed this record on May 23, 2013