Burns
Conditions
Keywords
burn wound, management with oxygen
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.
Interventions
DEVICEOxygen diffusing dressing
Oxygen diffusing dressing applied to study wound
Xeroform control dressing applied to control wound
Sponsors
United States Army Institute of Surgical Research
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Healing Time for Donor Site Wounds | number of days to healing | Wounds are inspected on postoperative days 4, 8, and then every two days until the wound is deemed to be healed. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pain Perceived by Patient | Post-Operative Day 4 | 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. |
| Patient Will be Asked to Rate Pain 0-10/10 at the Study Site and the Control Site | Post-Operative Day 8 | — |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 17 |
| Total | 17 |
Baseline characteristics
| Characteristic | Burn Wound Patients |
|---|---|
| Age, Continuous | 35 years |
| Burn Size | 9.2 percentage of total skin area |
| Sex: Female, Male Female | 3 Participants |
| Sex: Female, Male Male | 14 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 2 / 17 | 2 / 17 |
| serious Total, serious adverse events | 0 / 17 | 0 / 17 |
Outcome results
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.
Time frame: number of days to healing
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Study Dressing | Healing Time for Donor Site Wounds | 9.4 days | Standard Deviation 1.7 |
| Control Dressing | Healing Time for Donor Site Wounds | 12.4 days | Standard Deviation 2.7 |
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.
Time frame: Post-Operative Day 4
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Study Dressing | Pain Perceived by Patient | 0.6 units on a scale | Standard Deviation 1.6 |
| Control Dressing | Pain Perceived by Patient | 1.6 units on a scale | Standard Deviation 1.9 |
Secondary
Patient Will be Asked to Rate Pain 0-10/10 at the Study Site and the Control Site
Time frame: Post-Operative Day 8
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Study Dressing | Patient Will be Asked to Rate Pain 0-10/10 at the Study Site and the Control Site | 0.4 units on a scale | Standard Deviation 1.3 |
| Control Dressing | Patient Will be Asked to Rate Pain 0-10/10 at the Study Site and the Control Site | 1.4 units on a scale | Standard Deviation 2.2 |
Secondary
Patient Will be Asked to Rate Pain 0-10/10 at the Study Site and the Control Site
Time frame: Post-Operative Day 10
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Study Dressing | Patient Will be Asked to Rate Pain 0-10/10 at the Study Site and the Control Site | 0.3 units on a scale | Standard Deviation 1 |
| Control Dressing | Patient Will be Asked to Rate Pain 0-10/10 at the Study Site and the Control Site | 0.8 units on a scale | Standard Deviation 1.5 |
Secondary
Patient Will be Asked to Rate Pain 0-10/10 at the Study Site and the Control Site
Time frame: Post-Operative Day 12
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Study Dressing | Patient Will be Asked to Rate Pain 0-10/10 at the Study Site and the Control Site | 0.2 units on a scale | Standard Deviation 0.8 |
| Control Dressing | Patient Will be Asked to Rate Pain 0-10/10 at the Study Site and the Control Site | 0.5 units on a scale | Standard Deviation 1.2 |