Antibiotic Prophylaxis Before Percutaneous Gastrostomy

Infection Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01424085
• Other study ID #: 40912-B
• Status: Completed
• Phase: N/A
• First received: August 24, 2011
• Last updated: July 7, 2016
• Start date: May 2012
• Est. completion date: February 2016

Study information

• Verified date: July 2016
• Source: University of Washington
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 124
• Est. completion date: February 2016
• Est. primary completion date: January 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 90 Years

Eligibility

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 Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Infection

Locations

Country	Name	City	State
United States	Harborview Medical Center	Seattle	Washington

Sponsors (1)

Lead Sponsor	Collaborator
University of Washington

Country where clinical trial is conducted

United States, 

References & 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):20 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	No