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

NCT01268189 | Completed Results

• 1 other identifier: H-09-008
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Burns

Keywords

burn wound; management with oxygen

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Pain Perceived by Patient

  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

Study Arms (1)

Burn wound patients with donor sites

EXPERIMENTAL

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; Device: Standard of care dressing

Interventions

Oxygen diffusing dressing DEVICE

Oxygen diffusing dressing applied to study wound

Also known as: OxyBand dressing

Burn wound patients with donor sites

Standard of care dressing DEVICE

Xeroform control dressing applied to control wound

Also known as: Xeroform dressing

Burn wound patients with donor sites

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• United States Army Institute of Surgical Research: lead

Study Sites (1)

US Army Institute of Surgical Research, Burn Center

Fort Sam Houston, Texas, 78234, United States

Location

MeSH Terms

Conditions

Burns

Condition Hierarchy (Ancestors)

Wounds and Injuries

Results Point of Contact

• Title: Leopoldo C. Cancio, COL, MC
• Organization: USAISR

leopoldo.c.cancio.mil@mail.mil

210-916-3301

Study Officials

• Kimberly F Lairet, MD

  US Army Institute of Surgical Research

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 21, 2010
• First Posted: December 29, 2010
• Study Start: August 1, 2010
• Primary Completion: March 1, 2012
• Study Completion: March 1, 2012
• Last Updated: October 9, 2015
• Results First Posted: October 9, 2015

Record last verified: 2015-09

Locations

US (1)