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| ID | Type | Description | Link |
|---|---|---|---|
| CDMRP-DM220077 | Other Grant/Funding Number | Department of Defense |
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| Name | Class |
|---|---|
| Congressionally Directed Medical Research Programs | FED |
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This study will compare the effectiveness of two different treatments for preventing infection from frostbite injuries. These two treatments are A) aloe vera and B) long-acting silver wound dressings. The investigators will also study the safety and effectiveness of Dalbavancin, an FDA approved antibiotic used for treating people who develop frostbite wound infections, as well as evaluate how frostbite damage to individuals' bodies may affect how fast their kidney clear drugs from their systems.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Aim 1: Aloe Vera | Active Comparator | Aloe Vera will be applied topically to participant's frostbitten tissues twice daily. |
|
| Aim 1: Long-Acting Silver Dressings | Experimental | Long-Acting Silver dressings will be applied topically to participant's frostbitten tissues every 4 days. |
|
| Aim 2: Dalbavancin | Experimental | Participants will receive one 1500mg dose of Dalbavancin intravenously. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Long-Acting silver dressings | Device | Mepilex Transfer Ag |
| |
| Measure | Description | Time Frame |
|---|---|---|
| The number of positive microbial wound cultures on admission | Aerobic wound swabs will be taken from area of frostbite injury and analyzed by the (University of Colorado Hospital) UCH clinical laboratory. A positive culture indicates an organism was identified by the wound swab. | Admission |
| The number of positive microbial wound cultures on hospital day 4 | Aerobic wound swabs will be taken from area of frostbite injury and analyzed by the (University of Colorado Hospital) UCH clinical laboratory. A positive culture indicates an organism was identified by the wound swab. | Hospital Day 4 |
| The number of positive microbial wound cultures on hospital day 8 | Aerobic wound swabs will be taken from area of frostbite injury and analyzed by the (University of Colorado Hospital) UCH clinical laboratory. A positive culture indicates an organism was identified by the wound swab. | Hospital Day 8 |
| The number of positive microbial wound cultures on hospital day 12 | Aerobic wound swabs will be taken from area of frostbite injury and analyzed by the (University of Colorado Hospital) UCH clinical laboratory. A positive culture indicates an organism was identified by the wound swab. | Hospital Day 12 |
| The number of positive microbial wound cultures on hospital day 16 | Aerobic wound swabs will be taken from area of frostbite injury and analyzed by the (University of Colorado Hospital) UCH clinical laboratory. A positive culture indicates an organism was identified by the wound swab. | Hospital Day 16 |
| The number of positive microbial wound cultures on hospital day 20 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Blaire Balstad | Contact | 303-724-7803 | blaire.balstad@cuanschutz.edu | |
| Tracey MacDermott | Contact | 303-724-2757 | tracey.macdermott@cuanschutz.edu |
| Name | Affiliation | Role |
|---|---|---|
| Arek Wiktor, MD | University of Colorado Anschtuz | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Colorado Denver Anschutz Medical Campus | Recruiting | Aurora | Colorado | 80045 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37450897 | Background | Mueller SW, Blass B, Molina KC, Gibson C, Krsak M, Kohler AD, Deeter L, Stalilonis J, Wiktor AJ. Augmented Renal Function in Burn Patients: Occurrence and Discordance With Commonly Used Methods to Assess Renal Function. J Burn Care Res. 2023 Nov 2;44(6):1298-1303. doi: 10.1093/jbcr/irad107. | |
| 33657205 | Background |
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Undetermined at this time
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| ID | Term |
|---|---|
| D005627 | Frostbite |
| ID | Term |
|---|---|
| D000067390 | Cold Injury |
| D014947 | Wounds and Injuries |
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| ID | Term |
|---|---|
| C469289 | dalbavancin |
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| Aloe Vera |
| Other |
Dermaid Aloe Vera |
|
| Dalbavancin | Drug | 1500mg IV dose |
|
Aerobic wound swabs will be taken from area of frostbite injury and analyzed by the (University of Colorado Hospital) UCH clinical laboratory. A positive culture indicates an organism was identified by the wound swab. |
| Hospital Day 20 |
| The number of positive microbial wound cultures on hospital day 24 | Aerobic wound swabs will be taken from area of frostbite injury and analyzed by the (University of Colorado Hospital) UCH clinical laboratory. A positive culture indicates an organism was identified by the wound swab. | Hospital Day 24 |
| The number of positive microbial wound cultures on hospital day 28 | Aerobic wound swabs will be taken from area of frostbite injury and analyzed by the (University of Colorado Hospital) UCH clinical laboratory. A positive culture indicates an organism was identified by the wound swab. | Hospital Day 28 |
| The number of positive microbial wound cultures on hospital day 32 | Aerobic wound swabs will be taken from area of frostbite injury and analyzed by the (University of Colorado Hospital) UCH clinical laboratory. A positive culture indicates an organism was identified by the wound swab. | Hospital Day 32 |
| The number of positive microbial wound cultures on hospital day 36 | Aerobic wound swabs will be taken from area of frostbite injury and analyzed by the (University of Colorado Hospital) UCH clinical laboratory. A positive culture indicates an organism was identified by the wound swab. | Hospital Day 36 |
| The number of positive microbial wound cultures on hospital day 40 | Aerobic wound swabs will be taken from area of frostbite injury and analyzed by the (University of Colorado Hospital) UCH clinical laboratory. A positive culture indicates an organism was identified by the wound swab. | Hospital Day 40 |
| The number of positive microbial wound cultures on hospital day 44 | Aerobic wound swabs will be taken from area of frostbite injury and analyzed by the (University of Colorado Hospital) UCH clinical laboratory. A positive culture indicates an organism was identified by the wound swab. | Hospital Day 44 |
| The number of positive microbial wound cultures on hospital day 48 | Aerobic wound swabs will be taken from area of frostbite injury and analyzed by the (University of Colorado Hospital) UCH clinical laboratory. A positive culture indicates an organism was identified by the wound swab. | Hospital Day 48 |
| The number of positive microbial wound cultures on hospital day 52 | Aerobic wound swabs will be taken from area of frostbite injury and analyzed by the (University of Colorado Hospital) UCH clinical laboratory. A positive culture indicates an organism was identified by the wound swab. | Hospital Day 52 |
| The number of positive microbial wound cultures on hospital day 56 | Aerobic wound swabs will be taken from area of frostbite injury and analyzed by the (University of Colorado Hospital) UCH clinical laboratory. A positive culture indicates an organism was identified by the wound swab. | Hospital Day 56 |
| The number of positive microbial wound cultures on hospital day 60 | Aerobic wound swabs will be taken from area of frostbite injury and analyzed by the (University of Colorado Hospital) UCH clinical laboratory. A positive culture indicates an organism was identified by the wound swab. | Hospital Day 60 |
| Number of gram positive cultures at admission | UCH clinical laboratory will identify cultures using MALDI-TOF MS (Matrix-Assisted Laser Desorption - Ionisation-Time of Flight Mass Spectrometry). | Admission |
| Number of gram positive cultures on hospital day 4 | UCH clinical laboratory will identify cultures using MALDI-TOF MS (Matrix-Assisted Laser Desorption - Ionisation-Time of Flight Mass Spectrometry). | Hospital Day 4 |
| Number of gram positive cultures on hospital day 8 | UCH clinical laboratory will identify cultures using MALDI-TOF MS (Matrix-Assisted Laser Desorption - Ionisation-Time of Flight Mass Spectrometry). | Hospital Day 8 |
| Number of gram positive cultures on hospital day 12 | UCH clinical laboratory will identify cultures using MALDI-TOF MS (Matrix-Assisted Laser Desorption - Ionisation-Time of Flight Mass Spectrometry). | Hospital Day 12 |
| Number of gram positive cultures on hospital day 16 | UCH clinical laboratory will identify cultures using MALDI-TOF MS (Matrix-Assisted Laser Desorption - Ionisation-Time of Flight Mass Spectrometry). | Hospital Day 16 |
| Number of gram positive cultures on hospital day 20 | UCH clinical laboratory will identify cultures using MALDI-TOF MS (Matrix-Assisted Laser Desorption - Ionisation-Time of Flight Mass Spectrometry). | Hospital Day 20 |
| Number of gram positive cultures on hospital day 24 | UCH clinical laboratory will identify cultures using MALDI-TOF MS (Matrix-Assisted Laser Desorption - Ionisation-Time of Flight Mass Spectrometry). | Hospital Day 24 |
| Number of gram positive cultures on hospital day 28 | UCH clinical laboratory will identify cultures using MALDI-TOF MS (Matrix-Assisted Laser Desorption - Ionisation-Time of Flight Mass Spectrometry). | Hospital Day 28 |
| Number of gram positive cultures on hospital day 32 | UCH clinical laboratory will identify cultures using MALDI-TOF MS (Matrix-Assisted Laser Desorption - Ionisation-Time of Flight Mass Spectrometry). | Hospital Day 32 |
| Number of gram positive cultures on hospital day 36 | UCH clinical laboratory will identify cultures using MALDI-TOF MS (Matrix-Assisted Laser Desorption - Ionisation-Time of Flight Mass Spectrometry). | Hospital Day 36 |
| Number of gram positive cultures on hospital day 40 | UCH clinical laboratory will identify cultures using MALDI-TOF MS (Matrix-Assisted Laser Desorption - Ionisation-Time of Flight Mass Spectrometry). | Hospital Day 40 |
| Number of gram positive cultures on hospital day 44 | UCH clinical laboratory will identify cultures using MALDI-TOF MS (Matrix-Assisted Laser Desorption - Ionisation-Time of Flight Mass Spectrometry). | Hospital Day 44 |
| Number of gram positive cultures on hospital day 48 | UCH clinical laboratory will identify cultures using MALDI-TOF MS (Matrix-Assisted Laser Desorption - Ionisation-Time of Flight Mass Spectrometry). | Hospital Day 48 |
| Number of gram positive cultures on hospital day 52 | UCH clinical laboratory will identify cultures using MALDI-TOF MS (Matrix-Assisted Laser Desorption - Ionisation-Time of Flight Mass Spectrometry). | Hospital Day 52 |
| Number of gram positive cultures on hospital day 56 | UCH clinical laboratory will identify cultures using MALDI-TOF MS (Matrix-Assisted Laser Desorption - Ionisation-Time of Flight Mass Spectrometry). | Hospital Day 56 |
| Number of gram positive cultures on hospital day 60 | UCH clinical laboratory will identify cultures using MALDI-TOF MS (Matrix-Assisted Laser Desorption - Ionisation-Time of Flight Mass Spectrometry). | Hospital Day 60 |
| Change in serum concentration of dalbavancin in plasma (mcg/ml) over time | 1, 4, 12 hours, and 1,2,3,4,6,8,10,13,16 (or date of discharge if earlier) days post dalbavancin infusion |
| Dalbavancin concentrations in subcutaneous tissue | Dalbavancin concentration measured in frostbitten subcutaneous tissue by mcg/g | Up to 12 weeks |
| Change in presence of Augmented Renal Clearance | Creatinine clearance will be calculated from a 12-hour urine collection, with the definition of Augmented Renal Clearance as: CrCl > 130mL/min. | Baseline, Up to 12 weeks |
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