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RECRUITING
NCT03476941
PHASE2

Antibiotic Irrigations for Intra-Abdominal Drains

Sponsor: Paolo Goffredo

View on ClinicalTrials.gov

Summary

Intra-abdominal abscesses are pus-filled pouches in the abdominal cavity. Current standard of care includes drain placement in the abscess cavity to reach source control as well as administration of systemic antibiotics. It is common practice to flush the drain on a daily basis to ensure patency. This study aims to analyze the clinical impact of a higher local concentration of antibiotics (rather than normal saline) provided through drain irrigation with an antimicrobial agent (Gentamicin and/or Clindamycin) compare to normal saline.

Key Details

Gender

All

Age Range

18 Years - 80 Years

Study Type

INTERVENTIONAL

Enrollment

50

Start Date

2019-04-01

Completion Date

2021-09-01

Last Updated

2019-06-06

Healthy Volunteers

Yes

Interventions

DRUG

Gentamicin Sulfate Inj 20mg/2ml vial for injection

Irrigate surgical drain with total amount of 5 mg in 10 ml volume twice/day for 7 days or until drain removal if less than 7 days of therapy.

DRUG

Clindamycin phosphate 6 mg/1ml for injection

Irrigate surgical drain with total amount of 12 mg in 10 ml volume once daily for 7 days or until drain removal if less than 7 days of therapy.

OTHER

Placebo

The placebo group will receive drain irrigation twice/day

Locations (1)

The University of Iowa

Iowa City, Iowa, United States