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

NCT ID: NCT01268189

Last Updated: 2015-10-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-08-31
• Study Completion Date: 2012-03-31

Brief Summary

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.

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.

Conditions

Burns

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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)

Group Type: EXPERIMENTAL

Oxygen diffusing dressing

Intervention Type: DEVICE

Oxygen diffusing dressing applied to study wound

Standard of care dressing

Intervention Type: DEVICE

Xeroform control dressing applied to control wound

Interventions

Oxygen diffusing dressing

Oxygen diffusing dressing applied to study wound

Intervention Type: DEVICE

Standard of care dressing

Xeroform control dressing applied to control wound

Intervention Type: DEVICE

Other Intervention Names

OxyBand dressing; Xeroform dressing

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

United States Army Institute of Surgical Research

FED

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Kimberly F Lairet, MD

Role: PRINCIPAL_INVESTIGATOR

US Army Institute of Surgical Research

Locations

US Army Institute of Surgical Research, Burn Center

Fort Sam Houston, Texas, United States

Countries

United States

Other Identifiers

H-09-008

Identifier Type: -

Identifier Source: org_study_id