RecruitingPhase 2NCT03476941

Antibiotic Irrigations for Intra-Abdominal Drains


Sponsor

Paolo Goffredo

Enrollment

50 participants

Start Date

Apr 1, 2019

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 80 Years

Inclusion Criteria3

  • Intra-abdominal abscess drained with catheter/drain
  • Treatment with systemic antibiotics
  • Able to consent

Exclusion Criteria1

  • Abscess(es) not amendable for an image guided drain placement.

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Interventions

DRUGGentamicin 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.

DRUGClindamycin 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.

OTHERPlacebo

The placebo group will receive drain irrigation twice/day


Locations(1)

The University of Iowa

Iowa City, Iowa, United States

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NCT03476941