- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01225107
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
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Methods
Design. The present study is a prospective, randomized, double-blind, placebo-controlled study of the effect of taking three times daily doses of cranberry extract in capsule form on the incidence of infection in burn patients.
Participants. Eighty patients suffering from burns and admitted to the Saint Elizabeth Regional Medical Center Burn Center, Lincoln, NE will take place in the proposed study.
Inclusion Criteria. Patients will be asked to participate in the study if the following criteria are met:
- 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 will not be asked to participate in the study if any of the following are present:
- 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.
A cranberry extract standardized by Ocean Spray Cranberries, Inc. will be placed into capsules in the Saint Elizabeth Regional Medical Center pharmacy. Each cranberry capsule will contain 500mg of cranberry extract. Placebo capsules will be made to look identical to cranberry capsules and will also be made at the Saint Elizabeth Regional Medical Center pharmacy. A staff pharmacist will separate the capsules into a cranberry extract group and a placebo group. A staff pharmacist will randomly assign patients to either the cranberry extract group or the placebo group. The patient, physicians, and research staff involved in data collection will be blinded to patient group assignment.
Procedure. After admission to the burn unit and after the physician has deemed that the patient is able to consume medication capsules orally, patients meeting all other selection criteria will be asked to participate in the study. Study rationale and procedures will be described to patients and informed consent will be obtained if patients indicate a willingness to participate. Basic demographic data, burn/wound related information and information pertaining to any other infections will be obtained. Participants will be randomly assigned to either the placebo or the cranberry group. Participants will be given one capsule as soon as possible after hospital admission (or as soon as they have been deemed capable of consuming medication capsules orally) and then as close as possible to 8 hours after the first dose. Patients will then be placed on an 8 hour dosing schedule (i.e., one capsule every 8 hours). Burn wounds will be examined for any clinical signs of infection as judged by attending physician on a daily basis. The determination as to whether an infection is present vs. absent will be made by a physician utilizing specific criteria. If signs of infection are present, cultures of the wound site will be taken and bacterial type will be recorded. After initial infection, wound sites will be observed to determine if infections resolve with treatment. If treatment does not seem to eradicate the infection, another bacterial culture will be taken and bacterial analysis will be performed and recorded. Data pertaining to wound infection and wound appearance will be taken on a daily basis throughout the duration of the patient's hospital stay. In addition, information pertaining to all infections present in each patient will be recorded on a daily basis throughout the patient's entire hospital stay. The determination as to whether other infections are present vs. absent will be made by a physician utilizing specific criteria.
Study Type
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Nebraska
-
Lincoln, Nebraska, United States, 68510
- Saint Elizabeth Regional Medical Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: Inert Placebo Capsule
|
Inert substance, 3 times per day in capsule form
|
Experimental: Cranberry Extract
|
500mg TID
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Overall Infection Rate
Time Frame: average of 17 days
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Time between study enrollment and acquisition of infection
Time Frame: average of 17 days
|
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
|
Collaborators and Investigators
Investigators
- Principal Investigator: David W Voigt, M.D., Saint Elizabeth Regional Medical Center
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 609-052
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Burn
-
Xequel Bio, Inc.United States Department of DefenseWithdrawnThermal Burn | Second Degree Burn
-
Indonesia UniversityRecruitingBurn Degree Second | Burn Degree ThirdIndonesia
-
XenoTherapeutics, Inc.Joseph M. Still Research Foundation, Inc.Active, not recruitingWound Heal | Thermal Burn | Burn Degree Second | Burns Degree Third | Burn (Disorder)United States
-
University Hospital Schleswig-HolsteinUniversity of LuebeckRecruitingSecond-degree Burn | Third-Degree BurnGermany
-
General Electric ResearchRecruitingBurn Wound | 2nd Degree Burn of the SkinUnited States
-
University Hospital, LinkoepingCompletedBurn Scar | Burns | Burn Second DegreeSweden
-
University of AlbertaRecruitingBurn Degree Second | Burn; Multiple Body Regions, Max. Second Degree | Third-Degree BurnCanada
-
S.K. Lerik General HospitalCompletedBurn Scar | Burns | Burn Degree Second | Electrical BurnIndonesia
-
Regenera Pharma LtdWithdrawnPartial Thickness Burn | Second Degree Burn Less Than 5%TBSAIsrael
-
First Affiliated Hospital, Sun Yat-Sen UniversityRecruiting
Clinical Trials on Inert Placebo Capsule
-
The AlfredRecruiting
-
University of Texas at AustinCompletedSocial Anxiety DisorderUnited States
-
University of Maryland, BaltimoreNational Institute on Aging (NIA)CompletedAneurysmUnited States
-
Dartmouth-Hitchcock Medical CenterCompletedChronic Obstructive Pulmonary DiseaseUnited States
-
University of British ColumbiaActive, not recruitingHyperglycemia | Diabetes | KetosisCanada
-
Alcobra Ltd.TerminatedAttention Deficit Hyperactivity Disorder (ADHD)United States, Israel
-
University of British ColumbiaActive, not recruitingHyperglycemia | Diabetes Mellitus, Type 2 | KetosisCanada
-
Quan JiangUnknown
-
Axetis AGUnknownNative Coronary Artery StenosisNetherlands
-
China National Center for Cardiovascular DiseasesFuwai Hospital, Chinese Academy of Medial Sciences, Shenzhen, ShenzhenRecruitingHypertension | Diabetes | HypercholesterolemiaChina