Antibiotic Irrigations for Intra-Abdominal Drains

Part of paid clinical trials in Iowa City, Iowa.

Sponsor
Paolo Goffredo
Study ID
NCT03476941
Phase
PHASE2
Status
Recruiting
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Conditions

  • Abdominal Abscess

Eligibility Criteria

Sex
ALL
Age
18 Years - 80 Years
Healthy Volunteers
Accepted

Interventions

  • Gentamicin Sulfate Inj 20mg/2ml vial for injection — DRUG
    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.
  • Clindamycin phosphate 6 mg/1ml for injection — DRUG
    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.
  • Placebo — OTHER
    The placebo group will receive drain irrigation twice/day

Study Details

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 Dates

Start date
Apr 1, 2019
Status verified
Jun 2019
Primary completion
May 1, 2021
Completion
Sep 1, 2021

Study Design

Enrollment
50 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Antibiotic Irrigation
    The drain will be irrigated twice/day with the above antibiotic solution for 7 days maximum
  • Placebo Comparator: Normal Saline Irrigation
    The drain will be irrigated twice/day with normal saline

Primary Outcome Measure

Duration of systemic antibiotics [ Time Frame: From initiation of systemic treatment until 1 month follow up ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
The University of IowaIowa CityIowa52242
John Keller
[email protected]
319-335-2123
Paolo Goffredo, MD (PRINCIPAL_INVESTIGATOR)
Thomas Granchi, MD (SUB_INVESTIGATOR)

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By research site
The University of Iowa· Iowa City, IA

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