Plaatsing van antibioticumpoeder in wonden tijdens de spoedeisende hulp (POWDER)
Plaatsing van antibioticumpoeder in wonden tijdens de Emergency Room (POWDER) -studie
This is the first prospective controlled study to determine whether the topical application of vancomycin powder reduces infection-related complications when applied to open fracture injuries in the acute emergency department setting.
Studie Overzicht
Gedetailleerde beschrijving
Open fracture injuries are highly susceptible to infection and infection-related complications. The current routine treatment for these injuries includes the use of systemic IV antibiotics. However, open fracture injuries often have compromised blood supply, reducing the amount of antibiotic that reaches the target tissue while increasing risk of injury to non-target organs. This trial aims to evaluate the effectiveness of early application of a topical vancomycin antibiotic powder on open fracture wounds, in combination with the usual treatment, in reducing the risk of infection seen in these injuries.
Studietype
Inschrijving (Geschat)
Fase
- Fase 4
Contacten en locaties
Studiecontact
- Naam: Robert A De Lorenzo, MD
- Telefoonnummer: 210-567-0056
- E-mail: DeLorenzo@uthscsa.edu
Studie Locaties
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Texas
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San Antonio, Texas, Verenigde Staten, 78229
- Werving
- University Hospital
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Contact:
- Robert DeLorenzo, MD
- Telefoonnummer: 210-567-4292
- E-mail: delorenzo@uthscsa.edu
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Contact:
- Stephanie Martinez
- Telefoonnummer: 210 450-8566
- E-mail: martinezs13@uthscsa.edu
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Hoofdonderzoeker:
- Robert A De Lorenzo, MD
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San Antonio, Texas, Verenigde Staten, 78234
- Nog niet aan het werven
- San Antonio Military Medical Center
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Hoofdonderzoeker:
- Steven G Schauer, DO
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Contact:
- Steven G Schauer, DO
- E-mail: steven.g.schauer.mil@mail.mil
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
Inclusion Criteria:
- Subject or Legal Authorized Representative (LAR) is willing and able to provide written informed consent.
- Adult 18 years of age or older.
- Open fracture of the humerus, radius, ulna, femur, tibia, and/or fibula.
- 24 hours or less has elapsed from the estimated time of injury to study intervention.
Exclusion Criteria:
- Time from injury > 24 hours.
- Subjects who have received acute operative care (e.g., washout in the operating room or fixation) of the open fracture at an outside facility.
- Subject or LAR speaks neither English nor Spanish. Note that subjects that are unable to participate in the consent process (e.g. intoxication, poly-trauma, will be enrolled into the observational arm where passive data collection will occur).
- High-potency antibiotic powder or solution applied to the wound prior to enrollment. Simple ointment (i.e., bacitracin ointment) or antibiotic-impregnated dressings will be permitted.
- Documented allergies or serious reactions to vancomycin. History of uncomplicated "red man syndrome" will not be considered a reason for exclusion.
- Pregnant subjects. If the subject is a female of childbearing potential, and she states that she is likely to be pregnant, a pregnancy test will be performed; if negative, the subject will be eligible for enrollment.
- Prisoners.
- Participation in other clinical research involving investigational antimicrobial products within 30 days of randomization.
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Preventie
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
|
Experimenteel: Intervention Arm
Subjects randomized to the Intervention Arm will receive usual care plus two (2) grams of Vancomycin powder administered topically. In the emergency room prior to surgical intervention, a qualified member of the study team or clinical team member will apply 2 grams of vancomycin powder directly to the open fracture site such that all visible surfaces of the wound are completely and uniformly covered, including bone edges. |
2 vials of Vancomycin 1g powder will be applied topically to the open fracture wound site.
Andere namen:
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Geen tussenkomst: Control Arm
Subjects randomized to the Control Arm will receive usual care for open long bone fracture as determined by the treating physician. |
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Geen tussenkomst: Observational Arm
Subjects who otherwise meet the criteria to be included in the study but are not able to provide consent, either themselves or through a Legally Authorized Representative, will be placed in the Observational Arm and receive usual care with no experimental intervention. |
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Deep-space infection rate at prophylaxis site
Tijdsspanne: Within one year of injury date
|
The percentage of participants who develop an infection of the study open fracture requiring post-operative surgical intervention within one year of injury. |
Within one year of injury date
|
Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Superficial infection rate requiring post-operative medical intervention
Tijdsspanne: Within one year of injury date
|
The percentage of participants who develop an infection of the study open fracture that requires post-operative medical intervention, including addition or change of antibiotic, bedside application of incision & drainage, needle aspiration, and bedside application of a drain. |
Within one year of injury date
|
|
Unplanned repeat visit rate
Tijdsspanne: Within one year of injury date
|
The percentage of participants who experience an unscheduled medical encounter related to open fracture-site infection. |
Within one year of injury date
|
|
Readmission rate for open fracture infection
Tijdsspanne: Within one year of injury date
|
The percentage of participants who are readmitted to the hospital due to infection or complication of the study open fracture. Included in this assessment is sepsis and sepsis-related conditions arising from an open fracture infection. |
Within one year of injury date
|
|
Death rate
Tijdsspanne: Within one year of injury date
|
The rate of death among participants from presumed or documented open fracture site infection, determined by documentation through reliable diagnostic means. |
Within one year of injury date
|
Medewerkers en onderzoekers
Onderzoekers
- Hoofdonderzoeker: Robert A De Lorenzo, MD, University of Texas
Studie record data
Bestudeer belangrijke data
Studie start (Werkelijk)
Primaire voltooiing (Geschat)
Studie voltooiing (Geschat)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Werkelijk)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- HSC20180520H
- W81XWH-18-2-0074 (Ander subsidie-/financieringsnummer: Department of Defense)
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
Beschrijving IPD-plan
Data will be shared through the use of the REDCap Web-based distributed data collection system. All sharing of data will conform to currently established DOD HRPO (Department of Defense Human Research Protection Office) human subject protection practices and will be in compliance with all appropriate state and federal confidentiality requirements and privacy guidelines.
IPD-tijdsbestek voor delen
Data will be made available within one year of study completion.
IPD-toegangscriteria voor delen
Research data obtained through this study will be made available to researchers and/or the general public as requested. The limitations on this policy are that data will not generally be available until such a time that it is submitted for publication. While data will be provided in a timely fashion, the actual timelines of availability of requested data will be specific to the data requested and any special sensitivity of the requested data set.
IPD delen Ondersteunend informatietype
- LEERPROTOCOOL
- SAP
- ICF
- ANALYTIC_CODE
- MVO
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
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