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Antibiotic Prophylaxis Before Percutaneous Gastrostomy

Sponsor
University of Washington (Other)
Overall Status
Completed
CT.gov ID
NCT01424085
Collaborator
(none)
124
Enrollment
1
Location
45
Duration (Months)
2.8
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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 or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    124 participants
    Observational Model:
    Case-Control
    Time Perspective:
    Prospective
    Official Title:
    Antibiotic Prophylaxis Before Percutaneous Gastrostomy: A Randomized, Controlled Clinical Trial
    Study Start Date :
    May 1, 2012
    Actual Primary Completion Date :
    Jan 1, 2016
    Actual Study Completion Date :
    Feb 1, 2016

    Arms and Interventions

    Arm Intervention/Treatment
    Those receiving antibiotics

    Patients who received one prophylactic dose of antibiotics.
    Placebo

    Patients who did not receive one prophylactic dose of antibiotics (received placebo).

    Outcome Measures

    Primary Outcome Measures

    1. Rate of infection [Within one month of the procedure (antibiotic dose, if given)]

      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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 90 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Locations

    Site City State Country Postal Code
    1 Harborview Medical Center Seattle Washington United States 98104

    Sponsors and Collaborators

    • University of Washington

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Chris Ingraham, Assistant Professor, MD, University of Washington
    ClinicalTrials.gov Identifier:
    NCT01424085
    Other Study ID Numbers:
    • 40912-B
    First Posted:
    Aug 26, 2011
    Last Update Posted:
    Jul 11, 2016
    Last Verified:
    Jul 1, 2016
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No

    Study Results

    No Results Posted as of Jul 11, 2016