Clinical Trials Logo

Clinical Trial 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.


Clinical Trial 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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention


Related Conditions & MeSH terms


NCT number NCT01225107
Study type Interventional
Source Saint Elizabeth Regional Medical Center
Contact
Status Withdrawn
Phase N/A
Start date October 2011
Completion date October 2013

See also
  Status Clinical Trial Phase
Withdrawn NCT01302457 - Oral Care Study on Burn Patients N/A
Completed NCT02729259 - H2O VR for Burns 2015 N/A
Completed NCT01965340 - Impact of Therapeutic Drug Monitoring on Anti-Infective Agents Amongst Severely Burned Patients Requiring ICU Admission N/A
Completed NCT01983280 - The Effect of Healing Touch on Sleep Patterns of Pediatric Burn Patients N/A
Completed NCT00591448 - Study in the Use of Virtual Reality as an Adjunct to Pain Control in Burn Patients N/A
Active, not recruiting NCT02083900 - Use of Banana Leaf Dressing on Donor Site Wounds Phase 2
Completed NCT00242970 - Hypertrophic Scarring After Facial Burn Phase 2
Completed NCT00585325 - Instilled Lidocaine vs Placebo for Pain Management During Vacuum Assisted Closure (VAC) Dressing Changes N/A
Terminated NCT00591162 - Bone Disease in Severely Burned Children Phase 2/Phase 3
Terminated NCT02452255 - Fenofibrate and Propranolol in Burn Patients Phase 2/Phase 3
Completed NCT03183622 - A Follow-up Study to Evaluate the Safety of ALLO-ASC-DFU in ALLO-ASC-BI-101 Clinical Trial N/A
Completed NCT02427659 - VR High Tech Pain Control Burn Wound Care N/A
Not yet recruiting NCT00253279 - Alterations in Protein Synthesis Rates of Burn Patients Measured Over Time Using PET Scans Phase 1
Completed NCT04516148 - A Randomized, Controlled Trial of the Effectiveness of Perioperative Antibiotics for Reduction of Burn Wound Bacterial Concentration Following Grafting Phase 4
Withdrawn NCT02029261 - Observational Study of Insulin Resistance and Muscle Wasting After Burn Injury
Completed NCT00993889 - Virtual Reality Analgesia During Pediatric Physical Therapy N/A
Terminated NCT01062191 - Altrazeal Range of Motion Study Comparing With Typical Carboxymethyl N/A
Completed NCT02394873 - A Study to Evaluate the Safety of ALLO-ASC-DFU in the Subjects With Deep Second-degree Burn Wound Phase 1
Completed NCT00239668 - Multicenter Benchmarking of Functional and Psychosocial Outcomes of Pediatric Burn Survivors
Completed NCT04781348 - Efficacy of Platelet Rich Plasma Injection Plus Fat Grafting as Compared to Fat Grafting Alone on Burn Scar by Using Vancouver Scar Scale Phase 4