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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
United States Army Institute of Surgical Research
ClinicalTrials.gov Identifier:
NCT01268189
First received: December 21, 2010
Last updated: January 15, 2013
Last verified: January 2013
  Purpose

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.


Condition Intervention
Burn Wound
Management With Oxygen
Device: Oxygen diffusing dressing
Device: Control dressing

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Evaluation of Oxygen Diffusion Dressing for Accelerating Healing of Donor Site and Other Wounds

Resource links provided by NLM:


Further study details as provided by United States Army Institute of Surgical Research:

Primary Outcome Measures:
  • Healing time for donor site wounds [ Time Frame: number of days to healing ] [ Designated as safety issue: No ]
    Wounds are inspected on postoperative days 4, 8, and then every two days until the wound is deemed to be healed.


Secondary Outcome Measures:
  • Pain perceived by patient [ Time Frame: assessed at each visit ] [ Designated as safety issue: No ]
    Patient will be asked to rate pain 0-10/10 at the study site and the control site

  • Cosmetic effect of healing [ Time Frame: 30-45 days after surgery ] [ Designated as safety issue: No ]
    Photos of the study and control wounds will be assessed and scored by an independent burn surgeon

  • Ease of use/application by surgeon [ Time Frame: assessed at the initial operation ] [ Designated as safety issue: No ]
    The surgeon will be asked to rate the ease of application of the study dressing compared to the control dressing.


Enrollment: 18
Study Start Date: August 2010
Study Completion Date: March 2012
Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Study dressing
Oxygen diffusing dressing applied to wound
Device: Oxygen diffusing dressing
Oxygen diffusing dressing applied to study wound
Other Name: OxyBand dressing
Active Comparator: Control dressing
Xeroform (current standard of care) dressing applied to wound
Device: Control dressing
Xeroform control dressing applied to control wound
Other Name: 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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, clopidigrel 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01268189

Locations
United States, Texas
US Army Institute of Surgical Research, Burn Center
Ft. Sam Houston, Texas, United States, 78234
Sponsors and Collaborators
United States Army Institute of Surgical Research
Investigators
Principal Investigator: Kimberly F Lairet, MD US Army Institute of Surgical Research
  More Information

No publications provided

Responsible Party: United States Army Institute of Surgical Research
ClinicalTrials.gov Identifier: NCT01268189     History of Changes
Other Study ID Numbers: H-09-008
Study First Received: December 21, 2010
Last Updated: January 15, 2013
Health Authority: United States: Federal Government

Keywords provided by United States Army Institute of Surgical Research:
burn wound
management with oxygen

Additional relevant MeSH terms:
Burns
Wounds and Injuries

ClinicalTrials.gov processed this record on August 18, 2014