Effect of Cranberry Extract on Infections in Burn Patients
A Randomized, Double-Blind, Placebo-Controlled Study of the Effect of Cranberry Extract on the Incidence of Infections in Burn Patients
1 other identifier
interventional
N/A
1 country
1
Brief Summary
Bacterial infections are a common complication in patients suffering from burns. These infections can cause significant morbidity and often mortality. Antimicrobial resistance coupled with the prevalence of burn-related infections warrants the identification of alternative substances in the treatment of burn-related infections. The cranberry has been examined as a potential agent in the prevention of other types of infections and it appears to have anti-adherence effects on bacteria. In addition, the cranberry has demonstrated general inhibitory effects against some types of bacteria suggesting that it may be a useful agent in the prevention of bacterial infections in burn patients. The purpose of the present study is to investigate the effect of cranberry extract on the incidence of infections in burn patients.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started Oct 2011
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 11, 2010
CompletedFirst Posted
Study publicly available on registry
October 20, 2010
CompletedStudy Start
First participant enrolled
October 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2013
CompletedOctober 13, 2016
October 1, 2016
2 years
August 11, 2010
October 12, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Overall Infection Rate
Patients will be enrolled in the study throughout the duration of their hospital stay. They will be assessed on a daily basis.
average of 17 days
Secondary Outcomes (1)
Time between study enrollment and acquisition of infection
average of 17 days
Study Arms (2)
Inert Placebo Capsule
PLACEBO COMPARATORCranberry Extract
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- Patients are admitted to the Saint Elizabeth Regional Medical Center Burn Unit.
- Age 19 and older.
- Patients have an expected hospital stay of 7 days or more.
- Patients are able to consume oral medication capsules.
You may not qualify if:
- Patients have a known infection.
- Patients are not able to consume oral medication capsules.
- Patients have any known allergies to cranberry or placebo components.
- Patients have known allergy to aspirin (cranberries may contain salicylic acid).
- Patients are pregnant or breast-feeding.
- Patients are taking warfarin
- Patients with known nephrolithiasis.
- Patients with renal impairment as evidenced by a creatinine clearance that is less than predicted by Cockroft-Gault formula.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Saint Elizabeth Regional Medical Center
Lincoln, Nebraska, 68510, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
David W Voigt, M.D.
Saint Elizabeth Regional Medical Center
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
August 11, 2010
First Posted
October 20, 2010
Study Start
October 1, 2011
Primary Completion
October 1, 2013
Study Completion
October 1, 2013
Last Updated
October 13, 2016
Record last verified: 2016-10