Effect of Cranberry Extract on Infections in Burn Patients
This study is not yet open for participant recruitment.
Verified July 2011 by Saint Elizabeth Regional Medical Center
Sponsor:
Saint Elizabeth Regional Medical Center
Information provided by:
Saint Elizabeth Regional Medical Center
ClinicalTrials.gov Identifier:
NCT01225107
First received: August 11, 2010
Last updated: July 19, 2011
Last verified: July 2011
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Burn |
Dietary Supplement: Cranberry Extract Drug: Inert Placebo Capsule |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Prevention |
| Official Title: | A Randomized, Double-Blind, Placebo-Controlled Study of the Effect of Cranberry Extract on the Incidence of Infections in Burn Patients |
Resource links provided by NLM:
Further study details as provided by Saint Elizabeth Regional Medical Center:
Primary Outcome Measures:
- Overall Infection Rate [ Time Frame: average of 17 days ] [ Designated as safety issue: No ]Patients will be enrolled in the study throughout the duration of their hospital stay. They will be assessed on a daily basis.
Secondary Outcome Measures:
- Time between study enrollment and acquisition of infection [ Time Frame: average of 17 days ] [ Designated as safety issue: No ]Patients will be enrolled in the study throughout the duration of their hospital stay. They will be assessed on a daily basis.
| Estimated Enrollment: | 80 |
| Study Start Date: | October 2011 |
| Estimated Study Completion Date: | October 2013 |
| Estimated Primary Completion Date: | October 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Placebo Comparator: Inert Placebo Capsule |
Drug: Inert Placebo Capsule
Inert substance, 3 times per day in capsule form
|
| Experimental: Cranberry Extract |
Dietary Supplement: Cranberry Extract
500mg TID
Other Name: Cranberry
|
Show Detailed Description Eligibility| Ages Eligible for Study: | 19 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01225107
Locations
| United States, Nebraska | |
| Saint Elizabeth Regional Medical Center | Not yet recruiting |
| Lincoln, Nebraska, United States, 68510 | |
| Contact: Pamela L Flax-Laws, M.A. 402-219-7584 pflaxlaws@stez.org | |
| Contact: David Voigt, M.D. 402-219-8732 dwvoigt@pol.net | |
| Principal Investigator: David W Voigt, M.D. | |
| Sub-Investigator: Zijun Hao, M.D. | |
Sponsors and Collaborators
Saint Elizabeth Regional Medical Center
Investigators
| Principal Investigator: | David W Voigt, M.D. | Saint Elizabeth Regional Medical Center |
More Information
No publications provided
| Responsible Party: | David Voigt, Saint Elizabeth Regional Medical Center |
| ClinicalTrials.gov Identifier: | NCT01225107 History of Changes |
| Other Study ID Numbers: | 609-052 |
| Study First Received: | August 11, 2010 |
| Last Updated: | July 19, 2011 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Saint Elizabeth Regional Medical Center:
|
Burns Infections Cranberry |
Additional relevant MeSH terms:
|
Burns Wounds and Injuries |
ClinicalTrials.gov processed this record on May 21, 2013