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

Burns Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01268189
• Other study ID #: H-09-008
• Status: Completed
• Phase: N/A
• First received: December 21, 2010
• Last updated: September 8, 2015
• Start date: August 2010
• Est. completion date: March 2012

Study information

• Verified date: September 2015
• Source: United States Army Institute of Surgical Research
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: March 2012
• Est. primary completion date: March 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Burns

Intervention

Device:
• Oxygen diffusing dressing
Oxygen diffusing dressing applied to study wound
• Standard of care dressing
Xeroform control dressing applied to control wound

Locations

Country	Name	City	State
United States	US Army Institute of Surgical Research, Burn Center	Ft. Sam Houston	Texas

Sponsors (1)

Lead Sponsor	Collaborator
United States Army Institute of Surgical Research

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	Patient Will be Asked to Rate Pain 0-10/10 at the Study Site and the Control Site		Post-Operative Day 8	No
Secondary	Patient Will be Asked to Rate Pain 0-10/10 at the Study Site and the Control Site		Post-Operative Day 10	No
Secondary	Patient Will be Asked to Rate Pain 0-10/10 at the Study Site and the Control Site		Post-Operative Day 12	No