Early application of topical antibiotic powder in open-fracture wounds: A strategy to prevent biofilm formation and infections.
Kimberly M Burbank, Steven G Schauer, Robert A De Lorenzo...
https://pubmed.ncbi.nlm.nih.gov/33937714Actively Recruiting
Led by Brooke Army Medical Center ยท Updated on 2025-02-11
417
Participants Needed
2
Research Sites
8 weeks
Total Duration
B
Brooke Army Medical Center
Lead Sponsor
C
Congressionally Directed Medical Research Programs
Collaborating Sponsor
This research aims to understand how the volume of blood transfusions affects antibiotic levels in patients with open wounds due to trauma. It addresses a common problem where many combat and civilian trauma patients receive blood transfusions, but it is unclear how these transfusions change antibiotic concentrations used to prevent infections in wounds. The study will develop data-driven dosing models based on the relationship between blood transfusions and antibiotic levels. Participants include trauma patients who receive antibiotics such as ampicillin/sulbactam, cefazolin, and others during hospitalization. They are grouped into those receiving minimal or no blood transfusions (up to 2 units) and those receiving massive transfusions (at least 3 units). Blood samples are collected at six set timepoints after antibiotic administration, often using routine clinical blood draws with limited extra sampling. During the study, blood samples are processed and analyzed to measure antibiotic concentrations. Researchers will examine how transfused blood volume influences these levels using statistical models and data collected over time up to 30 days post-enrollment. The study ensures participant data privacy under HIPAA and involves minimal additional risks, qualifying for a waiver of informed consent. The total monitoring period extends up to 30 days after enrollment with ongoing data analysis.
CONDITIONS
Antibiotic Concentrations After MassivE Transfusion Study
You may qualify if you...
You will not qualify if you...
Complete this quick 3-step screening to check your eligibility
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 18 hours after antibiotic administration
Participants who meet trauma criteria and receive specified antibiotics during hospitalization have blood samples collected at six intervals after antibiotic infusion to measure plasma antibiotic concentrations. Samples are often collected during routine clinical blood draws to minimize additional venipunctures, with up to two extra research-only draws if needed.
6 blood sample collections (aligned with clinical draws when possible)
Duration - Up to 30 days
Participants are observed for up to 30 days post-enrollment to assess blood transfusion volume and antibiotic concentration levels, with data collected for analysis of pharmacokinetics and transfusion effects.
Data collected through hospital records and clinical follow-up
Total: 2 locations
1
University of Colorado Hospital
Aurora, Colorado, United States, 80045
Actively Recruiting
2
Brooke Army Medical Center
Fort Sam Houston, Texas, United States, 78234
Not Yet Recruiting
S
Steven G Schauer, DO
J
Jessica Mendez, MS
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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