Antibiotic Prophylaxis Before Percutaneous Gastrostomy

Antibiotic Prophylaxis Before Percutaneous Gastrostomy: A Randomized, Controlled Clinical Trial

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 Overview

• Status: Completed
• Conditions: Infection

• Study Type: Observational
• Enrollment (Actual): 124

Contacts and Locations

Study Locations

• United States
  • Washington
    • Seattle, Washington, United States, 98104
      • Harborview Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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).

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Those receiving antibiotics; Patients who received one prophylactic dose of antibiotics.
Placebo; Patients who did not receive one prophylactic dose of antibiotics (received placebo).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of infection	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.	Within one month of the procedure (antibiotic dose, if given)

Collaborators and Investigators

• Sponsor: University of Washington

Publications and helpful links

General Publications

• Ahmad I, Mouncher A, Abdoolah A, Stenson R, Wright J, Daniels A, Tillett J, Hawthorne AB, Thomas G. Antibiotic prophylaxis for percutaneous endoscopic gastrostomy--a prospective, randomised, double-blind trial. Aliment Pharmacol Ther. 2003 Jul 15;18(2):209-15. doi: 10.1046/j.1365-2036.2003.01684.x.

Study record dates

Study Major Dates

• Study Start: May 1, 2012
• Primary Completion (Actual): January 1, 2016
• Study Completion (Actual): February 1, 2016

Study Registration Dates

• First Submitted: August 24, 2011
• First Submitted That Met QC Criteria: August 25, 2011
• First Posted (Estimate): August 26, 2011

Study Record Updates

• Last Update Posted (Estimate): July 11, 2016
• Last Update Submitted That Met QC Criteria: July 7, 2016
• Last Verified: July 1, 2016

More Information

Terms related to this study

• Other Study ID Numbers: 40912-B

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No