Antibiotic Prophylaxis Before Percutaneous Gastrostomy
1 other identifier
observational
124
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started May 2012
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 24, 2011
CompletedFirst Posted
Study publicly available on registry
August 26, 2011
CompletedStudy Start
First participant enrolled
May 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2016
CompletedJuly 11, 2016
July 1, 2016
3.7 years
August 24, 2011
July 7, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
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)
Study Arms (2)
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 Criteria
Anyone referred to Interventional Radiology for percutaneous gastrostomy is in the study population (with inclusion and exclusion criteria below).
You may qualify if:
- Anyone over the age of 18 years who is not currently on antibiotics for other reasons
You may not qualify if:
- Anyone on antibiotics for the treatment of other infections.
- Anyone under the age of 18 years
- Pregnant patients
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Harborview Medical Center
Seattle, Washington, 98104, United States
Related Publications (1)
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.
PMID: 12869081RESULT
MeSH Terms
Conditions
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor, MD
Study Record Dates
First Submitted
August 24, 2011
First Posted
August 26, 2011
Study Start
May 1, 2012
Primary Completion
January 1, 2016
Study Completion
February 1, 2016
Last Updated
July 11, 2016
Record last verified: 2016-07
Data Sharing
- IPD Sharing
- Will not share