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Antibiotic Prophylaxis Before Percutaneous Gastrostomy

This study is not yet open for participant recruitment.
Verified August 2011 by University of Washington
Sponsor:
Information provided by (Responsible Party):
Chris Ingraham, University of Washington
ClinicalTrials.gov Identifier:
NCT01424085
First received: August 24, 2011
Last updated: August 25, 2011
Last verified: August 2011
History of Changes
  Purpose

The purpose of this study is to evaluate the use of antibiotics (i.e. Kefzol) before percutaneous gastrostomy performed in interventional radiology. Patient will be randomized to receive antibiotics or placebo before the procedure, and the rates of skin infection after the procedure will be determined between the two groups. This has never been studied in our population of patients undergoing the procedure. However, antibiotics are routinely given despite the lack of evidence. The investigators hypothesize that patient receiving prophylactic antibiotics will have a decreased number of infections compared to placebo.


Condition
Infection

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Antibiotic Prophylaxis Before Percutaneous Gastrostomy: A Randomized, Controlled Clinical Trial

Resource links provided by NLM:

MedlinePlus related topics: Antibiotics
U.S. FDA Resources

Further study details as provided by University of Washington:

Primary Outcome Measures:
  • Rate of infection [ Time Frame: Within one month of the procedure (antibiotic dose, if given) ] [ Designated as safety issue: No ]
    Wounds surround the g-tube will be assessed at 4 points after the procedure to document the presence of infection. An assessment for redness, induration, pus, etc. will be performed and documented at 4 times points after the procedure.


Estimated Enrollment: 64
Study Start Date: September 2011
Groups/Cohorts
Those receiving antibiotics
Patients who received one prophylactic dose of antibiotics.
Placebo
Patients who did not receive one prophylactic dose of antibiotics (received placebo).

  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Anyone referred to Interventional Radiology for percutaneous gastrostomy is in the study population (with inclusion and exclusion criteria below).

Criteria

Inclusion Criteria:

  • Anyone over the age of 18 years who is not currently on antibiotics for other reasons

Exclusion Criteria:

  • Anyone on antibiotics for the treatment of other infections.
  • Anyone under the age of 18 years
  • Pregnant patients
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01424085

Contacts
Contact: Emily Albrecht, PA-C 206-543-5972 emilya@u.washington.edu

Locations
United States, Washington
Harborview Medical Center Not yet recruiting
Seattle, Washington, United States, 98104
Contact: Emily Albrecht, PA-C     206-543-5972     emilya@u.washington.edu    
Sponsors and Collaborators
University of Washington
  More Information

Publications:

Responsible Party: Chris Ingraham, Radiology Resident, MD, University of Washington
ClinicalTrials.gov Identifier: NCT01424085     History of Changes
Other Study ID Numbers: 40912-B
Study First Received: August 24, 2011
Last Updated: August 25, 2011
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 23, 2013