Antibiotic Prophylaxis Before Percutaneous Gastrostomy

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2015 by University of Washington
Information provided by (Responsible Party):
Chris Ingraham, University of Washington Identifier:
First received: August 24, 2011
Last updated: December 3, 2015
Last verified: December 2015
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.


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:

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: 128
Study Start Date: May 2012
Estimated Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)
Those receiving antibiotics
Patients who received one prophylactic dose of antibiotics.
Patients who did not receive one prophylactic dose of antibiotics (received placebo).


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).

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01424085

Contact: Emily Albrecht, PA-C 206-543-5972

United States, Washington
Harborview Medical Center Recruiting
Seattle, Washington, United States, 98104
Contact: Emily Albrecht, PA-C    206-543-5972   
Sponsors and Collaborators
University of Washington
  More Information

Responsible Party: Chris Ingraham, Assistant Professor, MD, University of Washington Identifier: NCT01424085     History of Changes
Other Study ID Numbers: 40912-B 
Study First Received: August 24, 2011
Last Updated: December 3, 2015
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Anti-Bacterial Agents
Antibiotics, Antitubercular
Anti-Infective Agents
Antitubercular Agents processed this record on May 24, 2016