FrostbitePhase 4FrostbiteNCT06266494
Prevention and Treatment of Frostbite Infection With Antimicrobial Pharmacokinetic Analysis
A Phase 4 study testing Long-Acting silver dressings, Aloe Vera and Dalbavancin in people with Frostbite, run by University of Colorado, Denver at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 99 yearsHealthy volunteers can take part
- Conditions the study is for
- Frostbite
- What is being tested?
- Long-Acting silver dressings, Aloe Vera and Dalbavancin
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Mar 2024to Aug 2026
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- All aims, aged ≥18 - < 99 years old admitted to UCH Burn Center with frostbite injury
- Aim 1: Admitted to UCH Burn Center with acute (within 4 days of cold exposure) frostbite injury
- Aim 2: Admitted to UCH Burn center with a clinically confirmed or suspected infected frostbite wound
Who cannot join
- Pregnant patients
- Prisoners
- Anticipated death within 48 hours of admission
- Inability to obtain consent from patient, legally authorized representative, or proxy
- Aim 1:Patients admitted five days and later from frostbite injury. Patients who have a clinical infection at baseline. Any patients that have a contra-indication for the use of either aloe (allergy), or silver (allergy).
- Aim 2: Any patients that have a contraindication for use of dalbavancin, including known history of hypersensitivity to dalbavancin, vancomycin, or other glycopeptide antibiotics. Patients with infections known to be caused by vancomycin-resistant Enterococcus; or those with Stage IV or V chronic kidney disease, or with cirrhosis (Childs-Pugh C); or those with anticipated death within 48 hours of infection.
- Aim 3: Anuria due to chronic kidney disease (CKD)
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
University of Colorado Denver Anschutz Medical Campus
Aurora, Colorado, 80045
Blaire Balstad, 303-724-7803, blaire.balstad@cuanschutz.edu
Tracey MacDermott, 303-724-2757, tracey.macdermott@cuanschutz.edu
About this study
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.
- Conditions
- Frostbite
- Being tested
- Long-Acting silver dressings, Aloe Vera, Dalbavancin
- Medical subject headings
- Frostbite
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Long-Acting silver dressingsDevice
Mepilex Transfer Ag
Aloe VeraOther
Dermaid Aloe Vera
DalbavancinDrug
1500mg IV dose
| Study group | Role | What they receive |
|---|---|---|
| Aim 1: Aloe Vera | Active comparator | Aloe Vera will be applied topically to participant's frostbitten tissues twice daily. Receives: Other: Aloe Vera |
| Aim 1: Long-Acting Silver Dressings | Experimental | Long-Acting Silver dressings will be applied topically to participant's frostbitten tissues every 4 days. Receives: Device: Long-Acting silver dressings |
| Aim 2: Dalbavancin | Experimental | Participants will receive one 1500mg dose of Dalbavancin intravenously. Receives: Drug: Dalbavancin |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Hospital Day 16
The number of positive microbial wound cultures on hospital day 20
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: Hospital Day 60
Change in serum concentration of dalbavancin in plasma (mcg/ml) over time
Measured: 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
Measured: 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.
Measured: Baseline, Up to 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2024
- Study start1 Mar 2024
- Primary completionMay 2026 (estimated)
- Study completionAug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (43)Papers the sponsor has linked to this study.
- Other trials for FrostbiteStudies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Collaborators
- Congressionally Directed Medical Research Programs
- Responsible party
- Sponsor
- Investigators
- Arek Wiktor, MD, Principal investigator, University of Colorado Anschtuz
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06266494
- Sponsor's protocol ID
- 23-1349
- Other IDs
- CDMRP-DM220077
- Acronym
- Frostbite
- Status last verified
- May 2024
- First submitted
- 29 Jan 2024
- Last updated
- 13 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided: Undetermined at this time
Publications
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.
PubMed 37450897Carmichael H, Michel S, Smith TM, Duffy PS, Wiktor AJ, Lambert Wagner A. Remote Delivery of Thrombolytics Prior to Transfer to a Regional Burn Center for Tissue Salvage in Frostbite: A Single-center Experience of 199 Patients. J Burn Care Res. 2022 Jan 5;43(1):54-60. doi: 10.1093/jbcr/irab041.
PubMed 33657205Torian SC, Wiktor AJ, Roper SE, Laramie KE, Miller MA, Mueller SW. Burn Injury and Augmented Renal Clearance: A Case for Optimized Piperacillin-Tazobactam Dosing. J Burn Care Res. 2023 Jan 5;44(1):203-206. doi: 10.1093/jbcr/irac138.
PubMed 36173707Barletta JF, Mangram AJ, Byrne M, Sucher JF, Hollingworth AK, Ali-Osman FR, Shirah GR, Haley M, Dzandu JK. Identifying augmented renal clearance in trauma patients: Validation of the Augmented Renal Clearance in Trauma Intensive Care scoring system. J Trauma Acute Care Surg. 2017 Apr;82(4):665-671. doi: 10.1097/TA.0000000000001387.
PubMed 28129261Udy AA, Jarrett P, Stuart J, Lassig-Smith M, Starr T, Dunlop R, Wallis SC, Roberts JA, Lipman J. Determining the mechanisms underlying augmented renal drug clearance in the critically ill: use of exogenous marker compounds. Crit Care. 2014 Nov 29;18(6):657. doi: 10.1186/s13054-014-0657-z.
PubMed 25432141Cook AM, Hatton-Kolpek J. Augmented Renal Clearance. Pharmacotherapy. 2019 Mar;39(3):346-354. doi: 10.1002/phar.2231. Epub 2019 Mar 11.
PubMed 30723936Dunne MW, Puttagunta S, Giordano P, Krievins D, Zelasky M, Baldassarre J. A Randomized Clinical Trial of Single-Dose Versus Weekly Dalbavancin for Treatment of Acute Bacterial Skin and Skin Structure Infection. Clin Infect Dis. 2016 Mar 1;62(5):545-51. doi: 10.1093/cid/civ982. Epub 2015 Nov 26.
PubMed 26611777Carrothers TJ, Chittenden JT, Critchley I. Dalbavancin Population Pharmacokinetic Modeling and Target Attainment Analysis. Clin Pharmacol Drug Dev. 2020 Jan;9(1):21-31. doi: 10.1002/cpdd.695. Epub 2019 May 14.
PubMed 31087630Mangum LC, Garcia GR, Akers KS, Wenke JC. Duration of extremity tourniquet application profoundly impacts soft-tissue antibiotic exposure in a rat model of ischemia-reperfusion injury. Injury. 2019 Dec;50(12):2203-2214. doi: 10.1016/j.injury.2019.09.025. Epub 2019 Sep 20.
PubMed 31591007Kam PC, Kavanagh R, Yoong FF. The arterial tourniquet: pathophysiological consequences and anaesthetic implications. Anaesthesia. 2001 Jun;56(6):534-45. doi: 10.1046/j.1365-2044.2001.01982.x.
PubMed 11412159Dunne MW, Puttagunta S, Sprenger CR, Rubino C, Van Wart S, Baldassarre J. Extended-duration dosing and distribution of dalbavancin into bone and articular tissue. Antimicrob Agents Chemother. 2015 Apr;59(4):1849-55. doi: 10.1128/AAC.04550-14. Epub 2015 Jan 5.
PubMed 25561338Nicolau DP, Sun HK, Seltzer E, Buckwalter M, Dowell JA. Pharmacokinetics of dalbavancin in plasma and skin blister fluid. J Antimicrob Chemother. 2007 Sep;60(3):681-4. doi: 10.1093/jac/dkm263. Epub 2007 Jul 12.
PubMed 17631507Morrisette T, Miller MA, Montague BT, Barber GR, McQueen RB, Krsak M. On- and off-label utilization of dalbavancin and oritavancin for Gram-positive infections. J Antimicrob Chemother. 2019 Aug 1;74(8):2405-2416. doi: 10.1093/jac/dkz162.
PubMed 31322694Molina KC, Lunowa C, Lebin M, Segerstrom Nunez A, Azimi SF, Krsak M, Mueller SW, Miller MA. Comparison of Sequential Dalbavancin With Standard-of-Care Treatment for Staphylococcus aureus Bloodstream Infections. Open Forum Infect Dis. 2022 Jul 14;9(7):ofac335. doi: 10.1093/ofid/ofac335. eCollection 2022 Jul.
PubMed 35899276Cain AR, Bremmer DN, Carr DR, Buchanan C, Jacobs M, Walsh TL, Moffa MA, Shively NR, Trienski TL. Effectiveness of Dalbavancin Compared With Standard of Care for the Treatment of Osteomyelitis: A Real-world Analysis. Open Forum Infect Dis. 2021 Dec 18;9(2):ofab589. doi: 10.1093/ofid/ofab589. eCollection 2022 Feb.
PubMed 35071682
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevention and Treatment of Frostbite Infection With Antimicrobial Pharmacokinetic Analysis
- ClinicalTrials.gov ID
- NCT06266494
- Acronym / sponsor ID
- Frostbite / 23-1349
- Conditions
- Frostbite
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Collaborators
- Congressionally Directed Medical Research Programs
- Study start
- 1 Mar 2024 (actual)
- Primary completion
- May 2026 (estimated)
- Study completion
- Aug 2026 (estimated)
- First posted
- 20 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Aim 1: Aloe Vera | Active comparator | Other: Aloe VeraAloe Vera will be applied topically to participant's frostbitten tissues twice daily. |
| Aim 1: Long-Acting Silver Dressings | Experimental | Device: Long-Acting silver dressingsLong-Acting Silver dressings will be applied topically to participant's frostbitten tissues every 4 days. |
| Aim 2: Dalbavancin | Experimental | Drug: DalbavancinParticipants will receive one 1500mg dose of Dalbavancin intravenously. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- All aims, aged ≥18 - < 99 years old admitted to UCH Burn Center with frostbite injury
- Aim 1: Admitted to UCH Burn Center with acute (within 4 days of cold exposure) frostbite injury
- Aim 2: Admitted to UCH Burn center with a clinically confirmed or suspected infected frostbite wound
Key exclusion criteria (7 listed)
- Pregnant patients
- Prisoners
- Anticipated death within 48 hours of admission
- Inability to obtain consent from patient, legally authorized representative, or proxy
- Aim 1:Patients admitted five days and later from frostbite injury. Patients who have a clinical infection at baseline. Any patients that have a contra-indication for the use of either aloe (allergy), or silver (allergy).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Long-Acting silver dressingsMepilex Transfer Ag | Device | Aim 1: Long-Acting Silver Dressings |
| Aloe VeraDermaid Aloe Vera | Other | Aim 1: Aloe Vera |
| Dalbavancin1500mg IV dose | Drug | Aim 2: Dalbavancin |
Primary outcome
The number of positive microbial wound cultures on admission
Time frame: 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.
The number of positive microbial wound cultures on hospital day 4
Time frame: 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.
The number of positive microbial wound cultures on hospital day 8
Time frame: 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.
The number of positive microbial wound cultures on hospital day 12
Time frame: 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.
The number of positive microbial wound cultures on hospital day 16
Time frame: 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.
The number of positive microbial wound cultures on hospital day 20
Time frame: Hospital Day 20
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.
The number of positive microbial wound cultures on hospital day 24
Time frame: 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.
The number of positive microbial wound cultures on hospital day 28
Time frame: 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.
The number of positive microbial wound cultures on hospital day 32
Time frame: 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.
The number of positive microbial wound cultures on hospital day 36
Time frame: 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.
The number of positive microbial wound cultures on hospital day 40
Time frame: 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.
The number of positive microbial wound cultures on hospital day 44
Time frame: 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.
The number of positive microbial wound cultures on hospital day 48
Time frame: 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.
The number of positive microbial wound cultures on hospital day 52
Time frame: 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.
The number of positive microbial wound cultures on hospital day 56
Time frame: 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.
The number of positive microbial wound cultures on hospital day 60
Time frame: 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.
Number of gram positive cultures at admission
Time frame: Admission
UCH clinical laboratory will identify cultures using MALDI-TOF MS (Matrix-Assisted Laser Desorption - Ionisation-Time of Flight Mass Spectrometry).
Number of gram positive cultures on hospital day 4
Time frame: Hospital Day 4
UCH clinical laboratory will identify cultures using MALDI-TOF MS (Matrix-Assisted Laser Desorption - Ionisation-Time of Flight Mass Spectrometry).
Number of gram positive cultures on hospital day 8
Time frame: Hospital Day 8
UCH clinical laboratory will identify cultures using MALDI-TOF MS (Matrix-Assisted Laser Desorption - Ionisation-Time of Flight Mass Spectrometry).
Number of gram positive cultures on hospital day 12
Time frame: Hospital Day 12
UCH clinical laboratory will identify cultures using MALDI-TOF MS (Matrix-Assisted Laser Desorption - Ionisation-Time of Flight Mass Spectrometry).
Number of gram positive cultures on hospital day 16
Time frame: Hospital Day 16
UCH clinical laboratory will identify cultures using MALDI-TOF MS (Matrix-Assisted Laser Desorption - Ionisation-Time of Flight Mass Spectrometry).
Number of gram positive cultures on hospital day 20
Time frame: Hospital Day 20
UCH clinical laboratory will identify cultures using MALDI-TOF MS (Matrix-Assisted Laser Desorption - Ionisation-Time of Flight Mass Spectrometry).
Number of gram positive cultures on hospital day 24
Time frame: Hospital Day 24
UCH clinical laboratory will identify cultures using MALDI-TOF MS (Matrix-Assisted Laser Desorption - Ionisation-Time of Flight Mass Spectrometry).
Number of gram positive cultures on hospital day 28
Time frame: Hospital Day 28
UCH clinical laboratory will identify cultures using MALDI-TOF MS (Matrix-Assisted Laser Desorption - Ionisation-Time of Flight Mass Spectrometry).
Number of gram positive cultures on hospital day 32
Time frame: Hospital Day 32
UCH clinical laboratory will identify cultures using MALDI-TOF MS (Matrix-Assisted Laser Desorption - Ionisation-Time of Flight Mass Spectrometry).
Number of gram positive cultures on hospital day 36
Time frame: Hospital Day 36
UCH clinical laboratory will identify cultures using MALDI-TOF MS (Matrix-Assisted Laser Desorption - Ionisation-Time of Flight Mass Spectrometry).
Number of gram positive cultures on hospital day 40
Time frame: Hospital Day 40
UCH clinical laboratory will identify cultures using MALDI-TOF MS (Matrix-Assisted Laser Desorption - Ionisation-Time of Flight Mass Spectrometry).
Number of gram positive cultures on hospital day 44
Time frame: Hospital Day 44
UCH clinical laboratory will identify cultures using MALDI-TOF MS (Matrix-Assisted Laser Desorption - Ionisation-Time of Flight Mass Spectrometry).
Number of gram positive cultures on hospital day 48
Time frame: Hospital Day 48
UCH clinical laboratory will identify cultures using MALDI-TOF MS (Matrix-Assisted Laser Desorption - Ionisation-Time of Flight Mass Spectrometry).
Number of gram positive cultures on hospital day 52
Time frame: Hospital Day 52
UCH clinical laboratory will identify cultures using MALDI-TOF MS (Matrix-Assisted Laser Desorption - Ionisation-Time of Flight Mass Spectrometry).
Number of gram positive cultures on hospital day 56
Time frame: Hospital Day 56
UCH clinical laboratory will identify cultures using MALDI-TOF MS (Matrix-Assisted Laser Desorption - Ionisation-Time of Flight Mass Spectrometry).
Number of gram positive cultures on hospital day 60
Time frame: Hospital Day 60
UCH clinical laboratory will identify cultures using MALDI-TOF MS (Matrix-Assisted Laser Desorption - Ionisation-Time of Flight Mass Spectrometry).
Change in serum concentration of dalbavancin in plasma (mcg/ml) over time
Time frame: 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
Time frame: Up to 12 weeks
Dalbavancin concentration measured in frostbitten subcutaneous tissue by mcg/g
Change in presence of Augmented Renal Clearance
Time frame: Baseline, Up to 12 weeks
Creatinine clearance will be calculated from a 12-hour urine collection, with the definition of Augmented Renal Clearance as: CrCl > 130mL/min.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2024.
- Background: PubMed 37450897Mueller 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.
- Background: PubMed 33657205Carmichael H, Michel S, Smith TM, Duffy PS, Wiktor AJ, Lambert Wagner A. Remote Delivery of Thrombolytics Prior to Transfer to a Regional Burn Center for Tissue Salvage in Frostbite: A Single-center Experience of 199 Patients. J Burn Care Res. 2022 Jan 5;43(1):54-60. doi: 10.1093/jbcr/irab041.
- Background: PubMed 36173707Torian SC, Wiktor AJ, Roper SE, Laramie KE, Miller MA, Mueller SW. Burn Injury and Augmented Renal Clearance: A Case for Optimized Piperacillin-Tazobactam Dosing. J Burn Care Res. 2023 Jan 5;44(1):203-206. doi: 10.1093/jbcr/irac138.
- Background: PubMed 28129261Barletta JF, Mangram AJ, Byrne M, Sucher JF, Hollingworth AK, Ali-Osman FR, Shirah GR, Haley M, Dzandu JK. Identifying augmented renal clearance in trauma patients: Validation of the Augmented Renal Clearance in Trauma Intensive Care scoring system. J Trauma Acute Care Surg. 2017 Apr;82(4):665-671. doi: 10.1097/TA.0000000000001387.
- Background: PubMed 25432141Udy AA, Jarrett P, Stuart J, Lassig-Smith M, Starr T, Dunlop R, Wallis SC, Roberts JA, Lipman J. Determining the mechanisms underlying augmented renal drug clearance in the critically ill: use of exogenous marker compounds. Crit Care. 2014 Nov 29;18(6):657. doi: 10.1186/s13054-014-0657-z.
- Background: PubMed 30723936Cook AM, Hatton-Kolpek J. Augmented Renal Clearance. Pharmacotherapy. 2019 Mar;39(3):346-354. doi: 10.1002/phar.2231. Epub 2019 Mar 11.
- Background: PubMed 26611777Dunne MW, Puttagunta S, Giordano P, Krievins D, Zelasky M, Baldassarre J. A Randomized Clinical Trial of Single-Dose Versus Weekly Dalbavancin for Treatment of Acute Bacterial Skin and Skin Structure Infection. Clin Infect Dis. 2016 Mar 1;62(5):545-51. doi: 10.1093/cid/civ982. Epub 2015 Nov 26.
- Background: PubMed 31087630Carrothers TJ, Chittenden JT, Critchley I. Dalbavancin Population Pharmacokinetic Modeling and Target Attainment Analysis. Clin Pharmacol Drug Dev. 2020 Jan;9(1):21-31. doi: 10.1002/cpdd.695. Epub 2019 May 14.
- Background: PubMed 31591007Mangum LC, Garcia GR, Akers KS, Wenke JC. Duration of extremity tourniquet application profoundly impacts soft-tissue antibiotic exposure in a rat model of ischemia-reperfusion injury. Injury. 2019 Dec;50(12):2203-2214. doi: 10.1016/j.injury.2019.09.025. Epub 2019 Sep 20.
- Background: PubMed 11412159Kam PC, Kavanagh R, Yoong FF. The arterial tourniquet: pathophysiological consequences and anaesthetic implications. Anaesthesia. 2001 Jun;56(6):534-45. doi: 10.1046/j.1365-2044.2001.01982.x.
- Background: PubMed 25561338Dunne MW, Puttagunta S, Sprenger CR, Rubino C, Van Wart S, Baldassarre J. Extended-duration dosing and distribution of dalbavancin into bone and articular tissue. Antimicrob Agents Chemother. 2015 Apr;59(4):1849-55. doi: 10.1128/AAC.04550-14. Epub 2015 Jan 5.
- Background: PubMed 17631507Nicolau DP, Sun HK, Seltzer E, Buckwalter M, Dowell JA. Pharmacokinetics of dalbavancin in plasma and skin blister fluid. J Antimicrob Chemother. 2007 Sep;60(3):681-4. doi: 10.1093/jac/dkm263. Epub 2007 Jul 12.
- Individual participant dataSharing planned: Undecided. Undetermined at this time
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Arek Wiktor, MD principal investigator
University of Colorado Anschtuz
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Long-Acting silver dressings, Aloe Vera and Dalbavancin in people with Frostbite, run by University of Colorado, Denver at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Blaire Balstad (303-724-7803, blaire.balstad@cuanschutz.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The number of positive microbial wound cultures on admission (time frame: Admission). The study lists 35 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06266494, which also lists 43 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 May 2024.