Effect of Cranberry Extract on Infections in Burn Patients

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2011 by Saint Elizabeth Regional Medical Center.
Recruitment status was  Not yet recruiting
Sponsor:
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
  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 July 22, 2014