Evaluation of Oxygen Diffusion Dressing for Accelerating Healing of Donor Site and Other Wounds

This is a single-center, prospective, randomized, and controlled study to evaluate the effectiveness of OxyBand Dressing for the use as a dressing for autogenous skin donor sites compared to our current standard donor site dressing (Xeroform). Hypothesis is that the mean healing time for wounds treated with the OxyBand dressing will be less than the mean healing time for wounds treated with the Xeroform dressing.

Study Overview

• Status: Completed
• Conditions: Burns
• Intervention / Treatment: Device: Oxygen diffusing dressing; Device: Standard of care dressing

Detailed Description

Patients who are scheduled for excision of burns or other injuries will have one of two donor sites covered with the OxyBand Dressing, and the other treated according to standard of care. OxyBand is an FDA (Food and Drug Administration) approved (K043063) wound dressing for delivery of oxygen into the wound. Two small clinical studies using OxyBand have been conducted on standardized laser burn wounds, demonstrating faster healing time compared to a placebo. No studies have compared this dressing to Xeroform dressing, the standard dressing used on donor sites in the USAISR.

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Texas
    • Ft. Sam Houston, Texas, United States, 78234
      • US Army Institute of Surgical Research, Burn Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Subject must be at least 18 years of age; of either gender and in good general health.
• Subject has sustained burn wounds of less than 30 percent of the total body surface area
• Burn wounds do not involve the harvesting area
• Subject has sustained burn wounds that, in the judgment of the attending surgeon, require excision and grafting of sufficient extent to justify two donor sites of equal and symmetrical size on non-dependent body surfaces areas
• The scheduled excision and grafting procedure is the first such operation for the subject during this hospitalization
• Subject agrees to participate in follow-up evaluations

Exclusion Criteria:

• Critical illnesses such as those requiring ventilator support, or having a systemic infection or hemodynamic instability, defined as a mean arterial pressure less than 60 or requiring vasoactive medications to support blood pressure
• Major acute or chronic medical illnesses that could affect wound healing (e.g. peripheral vascular disease, insulin dependent diabetes, blood clotting disorder)
• Subjects receiving treatment with medications that inhibit or compromise wound healing. Examples include therapeutic anticoagulants, antiplatelet drugs, and systemic steroids such as warfarin, clopidogrel or prednisone. The use of anticoagulants does not include DVT (Deep Vein Thrombosis) prophylaxis. Subjects may use aspirin or lovenox
• Cellulitis or other infection of the potential donor sites
• Donor site has been previously harvested for grafting
• Subjects with greater than 30% total body surface area burns
• Pregnancy
• Prisoners

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Burn wound patients with donor sites; Oxygen diffusing dressing applied to wound vs standard of care dressing (Xeroform) applied to wound (patient serves as own control as s/he receives 1 dressing on 1 donor site and the other on a 2nd donor site)	Device: Oxygen diffusing dressing; Oxygen diffusing dressing applied to study wound; Other Names: OxyBand dressing; Device: Standard of care dressing; Xeroform control dressing applied to control wound; Other Names: Xeroform dressing

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Healing Time for Donor Site Wounds	Wounds are inspected on postoperative days 4, 8, and then every two days until the wound is deemed to be healed.	number of days to healing

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain Perceived by Patient	Patient will be asked to rate pain 0-10 (0=no pain, 10=maximum pain) at the study site and the control site. Used Visual Analogue Scale (VAS) for this purpose.	Post-Operative Day 4
Patient Will be Asked to Rate Pain 0-10/10 at the Study Site and the Control Site		Post-Operative Day 8
Patient Will be Asked to Rate Pain 0-10/10 at the Study Site and the Control Site		Post-Operative Day 10
Patient Will be Asked to Rate Pain 0-10/10 at the Study Site and the Control Site		Post-Operative Day 12

Collaborators and Investigators

• Sponsor: United States Army Institute of Surgical Research
• Investigators: Principal Investigator: Kimberly F Lairet, MD, US Army Institute of Surgical Research

Study record dates

Study Major Dates

• Study Start: August 1, 2010
• Primary Completion (ACTUAL): March 1, 2012
• Study Completion (ACTUAL): March 1, 2012

Study Registration Dates

• First Submitted: December 21, 2010
• First Submitted That Met QC Criteria: December 28, 2010
• First Posted (ESTIMATE): December 29, 2010

Study Record Updates

• Last Update Posted (ESTIMATE): October 9, 2015
• Last Update Submitted That Met QC Criteria: September 8, 2015
• Last Verified: September 1, 2015

More Information

Terms related to this study

• Keywords: burn wound; management with oxygen
• Other Study ID Numbers: H-09-008