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

Primary Purpose

Edema, Ecchymosis

Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Hyperbaric oxygen treatment
Air sham
Sponsored by
Restorix Research Institute, LLLP
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Edema focused on measuring blepharoplasty, hyperbaric, oxygen, ecchymosis, edema, wound, healing

Eligibility Criteria

40 Years - 85 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Restorix Research Institute

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Hyperbaric oxygen therapy

Air sham

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

A measureable reduction of ecchymosis grade in treatment group vs. control group
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
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.

Full Information

First Posted
September 2, 2011
Last Updated
December 3, 2012
Sponsor
Restorix Research Institute, LLLP
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1. Study Identification

Unique Protocol Identification Number
NCT01605110
Brief Title
Effects of Hyperbaric Oxygen Therapy on Surgical Wound Healing
Acronym
BLEPH
Official Title
Effects of HBOT for Edema/Ecchymosis After Upper Eyelid Blepharoplasty (Single Site Study)
Study Type
Interventional

2. Study Status

Record Verification Date
December 2012
Overall Recruitment Status
Unknown status
Study Start Date
August 2011 (undefined)
Primary Completion Date
November 2013 (Anticipated)
Study Completion Date
December 2013 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Restorix Research Institute, LLLP

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Edema, Ecchymosis
Keywords
blepharoplasty, hyperbaric, oxygen, ecchymosis, edema, wound, healing

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
164 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Hyperbaric oxygen therapy
Arm Type
Experimental
Arm Description
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.
Arm Title
Air sham
Arm Type
Sham Comparator
Arm Description
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 Type
Drug
Intervention Name(s)
Hyperbaric oxygen treatment
Intervention Description
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).
Intervention Type
Drug
Intervention Name(s)
Air sham
Intervention Description
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.
Primary Outcome Measure Information:
Title
A measureable reduction of ecchymosis grade in treatment group vs. control group
Description
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.
Time Frame
21 days
Secondary Outcome Measure Information:
Title
A measureable reduction of edema grade in treatment group vs. control group
Description
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.
Time Frame
21 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bryan Sires, MD, FACS
Organizational Affiliation
Allure Laser Center & Medispa
Official's Role
Principal Investigator
Facility Information:
Facility Name
Restorix Research Institute
City
Issaquah
State/Province
Washington
ZIP/Postal Code
98027
Country
United States

12. IPD Sharing Statement

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Effects of Hyperbaric Oxygen Therapy on Surgical Wound Healing

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