Antibiotic Irrigations for Intra-Abdominal Drains (AID)

Paolo Goffredo

Status and phase: Enrolling; Phase 2

Conditions: Abdominal Abscess

Treatments: Drug: Gentamicin Sulfate Inj 20mg/2ml vial for injection; Other: Placebo; Drug: Clindamycin phosphate 6 mg/1ml for injection

Study type: Interventional

Funder types: Other

Identifiers

NCT03476941

201703759

Details and patient eligibility

About

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.

Full 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.

Enrollment: 50 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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50 participants in 2 patient groups, including a placebo group

Antibiotic Irrigation

Experimental group

Description:

The drain will be irrigated twice/day with the above antibiotic solution for 7 days maximum

Treatment:

Drug: Clindamycin phosphate 6 mg/1ml for injection

Drug: Gentamicin Sulfate Inj 20mg/2ml vial for injection

Normal Saline Irrigation

Placebo Comparator group

Description:

The drain will be irrigated twice/day with normal saline

Treatment:

Other: Placebo