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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Oxygen diffusing dressing | Device | Oxygen diffusing dressing applied to study wound |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kimberly F Lairet, MD | US Army Institute of Surgical Research | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| US Army Institute of Surgical Research, Burn Center | Fort Sam Houston | Texas | 78234 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Burn Wound Patients | Burn wound patients with experimental (oxyband) and control (Xeroform) dressings placed on 2 separate skin graft donor sites |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Subjects serve as their own control as experimental and standard of care dressings applied to 2 different donor sites. Total of 17 participants completed, with 34 donor sites.
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| ID | Title | Description |
|---|---|---|
| BG000 | Burn Wound Patients | Burn wound patients with oxygen diffusing dressing placed on 1 donor skin graft site and standard of care (Xeroform) dressing placed on a 2nd donor skin graft |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Mean | Standard Deviation | days | number of days to healing |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Study Dressing | Oxygen diffusing dressing applied to wound Oxygen diffusing dressing: Oxygen diffusing dressing applied to study wound |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Blistering | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Leopoldo C. Cancio, COL, MC | USAISR | 210-916-3301 | leopoldo.c.cancio.mil@mail.mil |
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| ID | Term |
|---|---|
| D002056 | Burns |
| ID | Term |
|---|---|
| D014947 | Wounds and Injuries |
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| Standard of care dressing | Device | Xeroform control dressing applied to control wound |
|
|
| 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 |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Burn Size | Mean | Full Range | percentage of total skin area |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| 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. | Posted | Mean | Standard Deviation | units on a scale | Post-Operative Day 4 |
|
|
|
| Secondary | Patient Will be Asked to Rate Pain 0-10/10 at the Study Site and the Control Site | Posted | Mean | Standard Deviation | units on a scale | Post-Operative Day 8 |
|
|
|
| Secondary | Patient Will be Asked to Rate Pain 0-10/10 at the Study Site and the Control Site | Posted | Mean | Standard Deviation | units on a scale | Post-Operative Day 10 |
|
|
|
| Secondary | Patient Will be Asked to Rate Pain 0-10/10 at the Study Site and the Control Site | Posted | Mean | Standard Deviation | units on a scale | Post-Operative Day 12 |
|
|
|
| 0 |
| 17 |
| 2 |
| 17 |
| EG001 | Control Dressing | Xeroform (current standard of care) dressing applied to wound Control dressing: Xeroform control dressing applied to control wound | 0 | 17 | 2 | 17 |
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