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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

September 2, 2011
December 3, 2012
August 2011
November 2013   (final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01605110 on ClinicalTrials.gov Archive Site
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.
Same as current
Not Provided
Not Provided
 
Effects of Hyperbaric Oxygen Therapy on Surgical Wound Healing
Effects of HBOT for Edema/Ecchymosis After Upper Eyelid Blepharoplasty (Single Site Study)

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

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
  • Edema
  • Ecchymosis
  • 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.
  • 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.
    Intervention: Drug: Hyperbaric oxygen treatment
  • 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.
    Intervention: Drug: Air sham
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Enrolling by invitation
164
December 2013
November 2013   (final data collection date for primary outcome measure)

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.
Both
40 Years to 85 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01605110
RRI-2011-02-BLEPH-00 BS
Yes
Restorix Research Institute, LLLP
Restorix Research Institute, LLLP
Not Provided
Principal Investigator: Bryan Sires, MD, FACS Allure Laser Center & Medispa
Restorix Research Institute, LLLP
December 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP