Effect of Cranberry Extract on Infections in Burn Patients
| Status: | Completed |
|---|---|
| Conditions: | Infectious Disease, Hospital |
| Therapuetic Areas: | Immunology / Infectious Diseases, Other |
| Healthy: | No |
| Age Range: | 19 - Any |
| Updated: | 4/2/2016 |
| Start Date: | October 2011 |
| End Date: | October 2013 |
A Randomized, Double-Blind, Placebo-Controlled Study of the Effect of Cranberry Extract on the Incidence of Infections in Burn Patients
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.
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.
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.
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.
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.
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