NCT03476941

Antibiotic Irrigations for Intra-Abdominal Drains

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: Paolo Goffredo · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Accepted

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.

Detailed description

People with an abdominal abscess who undergo drain placement will have those drains irrigated twice/day with either normal saline (placebo group) or with the above antibiotic solution for a total of 7 days or less if the drain were to be removed earlier. Outcomes of interest are duration of systemic antibiotics, and WBC and temperature curve.

Conditions

• Abdominal Abscess

Interventions

Type	Name	Description
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

Timeline

• Start date: 2019-04-01
• Primary completion: 2021-05-01
• Completion: 2021-09-01
• First posted: 2018-03-26
• Last updated: 2019-06-06

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study