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Antibiotic Prophylaxis Before Percutaneous Gastrostomy

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01424085
First Posted: August 26, 2011
Last Update Posted: July 11, 2016
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.
Information provided by (Responsible Party):
Chris Ingraham, University of Washington
August 24, 2011
August 26, 2011
July 11, 2016
May 2012
January 2016   (Final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01424085 on ClinicalTrials.gov Archive Site
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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.
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Observational
Observational Model: Case Control
Time Perspective: Prospective
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Probability Sample
Anyone referred to Interventional Radiology for percutaneous gastrostomy is in the study population (with inclusion and exclusion criteria below).
Infection
Not Provided
  • Those receiving antibiotics
    Patients who received one prophylactic dose of antibiotics.
  • Placebo
    Patients who did not receive one prophylactic dose of antibiotics (received placebo).
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
124
February 2016
January 2016   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years to 90 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01424085
40912-B
Yes
Not Provided
Plan to Share IPD: No
Chris Ingraham, University of Washington
University of Washington
Not Provided
Not Provided
University of Washington
July 2016