Antibiotic Prophylaxis Before Percutaneous Gastrostomy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01424085
Recruitment Status : Completed
First Posted : August 26, 2011
Last Update Posted : July 11, 2016
Information provided by (Responsible Party):
Chris Ingraham, University of Washington

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

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 2012
Actual Primary Completion Date : January 2016
Actual Study Completion Date : February 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Antibiotics

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

Primary Outcome Measures :
  1. Rate of infection [ Time Frame: 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.

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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).

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01424085

United States, Washington
Harborview Medical Center
Seattle, Washington, United States, 98104
Sponsors and Collaborators
University of Washington

Publications of Results:
Responsible Party: Chris Ingraham, Assistant Professor, MD, University of Washington Identifier: NCT01424085     History of Changes
Other Study ID Numbers: 40912-B
First Posted: August 26, 2011    Key Record Dates
Last Update Posted: July 11, 2016
Last Verified: July 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
Anti-Bacterial Agents
Antibiotics, Antitubercular
Anti-Infective Agents
Antitubercular Agents