Antibiotic Prophylaxis Before Percutaneous Gastrostomy

NCT ID: NCT01424085

Last Updated: 2016-07-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

124 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-05-31

Study Completion Date

2016-02-29

Brief Summary

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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.

Detailed Description

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Conditions

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Infection

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Those receiving antibiotics

Patients who received one prophylactic dose of antibiotics.

No interventions assigned to this group

Placebo

Patients who did not receive one prophylactic dose of antibiotics (received placebo).

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Washington

OTHER

Sponsor Role lead

Responsible Party

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Chris Ingraham

Assistant Professor, MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Harborview Medical Center

Seattle, Washington, United States

Site Status

Countries

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United States

References

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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.

Reference Type RESULT
PMID: 12869081 (View on PubMed)

Other Identifiers

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40912-B

Identifier Type: -

Identifier Source: org_study_id

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