Trials Today

Antibiotic Irrigations for Intra-Abdominal Drains

Purpose

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.

Condition

Abdominal Abscess

Eligibility

Eligible Ages: Between 18 Years and 80 Years
Eligible Genders: All
Accepts Healthy Volunteers: Yes

Inclusion Criteria

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

Exclusion Criteria

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

Study Design

Phase: Phase 2
Study Type: Interventional
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: There will be two group, study and control group. In control group, patient will receive standard intra-abdominal drain care with daily flushing of the drain with normal saline. In study group, patient will receive daily flush with antibiotic for 7 days.
Primary Purpose: Treatment
Masking: Single (Participant)
Masking Description: Written consent will be obtained from all participants. Then, each participant will be randomized into two arms. Nurse will administer the drain flush either with normal saline or antibiotic irrigation.

Arm Groups

Arm	Description	Assigned Intervention
Experimental Antibiotic Irrigation	The drain will be irrigated twice/day with the above antibiotic solution for 7 days maximum	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.
Placebo Comparator Normal Saline Irrigation	The drain will be irrigated twice/day with normal saline	Other: Placebo The placebo group will receive drain irrigation twice/day

Recruiting Locations

The University of Iowa
Iowa City, Iowa 52242

Contact:
John Keller
319-335-2123
dsp@uiowa.edu

More Details

NCT ID: NCT03476941
Status: Recruiting
Sponsor: Paolo Goffredo

Study Contact

Thomas Granchi, MD
319-356-1339
thomas-granchi@uiowa.edu

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.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.