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NCT Number: NCT03476941

Antibiotic Irrigations for Intra-Abdominal Drains

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.

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

The University of Iowa

Iowa City, Iowa, 52242, United States

Location status: Recruiting

Location contact

John Keller

CONTACT

[email protected]

319-335-2123

Paolo Goffredo, MD

PRINCIPAL_INVESTIGATOR

Thomas Granchi, MD

SUB_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Primary outcomes

  1. Duration of systemic antibiotics

    Time frame: From initiation of systemic treatment until 1 month follow up

    Total duration of systemic antibiotics will be recorded from the start of the treatment until discontinuation by primary care team. This will be measured as days from diagnosis to when the antibiotic treatment gets interrupted. Duration of systemic antibiotics will be our primary outcome measurement. Duration of systemic antibiotics will be monitored as an indication of the effectiveness of the proposed intervention.

Secondary outcomes

  1. White Blood Count

    Time frame: From initiation of systemic treatment until 1 month follow up

    White blood count level from the blood draw will be measured starting from the admission until discharge or discontinuation by primary care team. During follow up, if white blood count will be measured, will record up to 1 month follow up. The white blood count will be measured once daily and as needed depending on clinical changes. We will plan to trend WBC as another indication of decreasing systemic inflammation.

  2. Change in temperature

    Time frame: From initiation of systemic treatment until 1 month follow up

    Temperature will be measured every 8 hours starting from admission and until patient discharge. And also temperature will be measured during each follow up clinic visit. Change in temperature is monitored as an indication of decrease systemic inflammation.

  3. Changes in size of the Abscess

    Time frame: From patient initial hospitalization up to 1 month follow up

    CT scan of would have been obtained prior to image guided drain placement. Any subsequent CT scans up to 1 month follow up upon discharge will be reviewed to assess changes in size of the abscess. This will be monitored for assessing the effectiveness of intervention.

  4. Changes in Drain Output

    Time frame: From the drain placement up to 1 month follow up

    Drain will have certain output that is recorded daily. Daily drain output will be in unit of ml and will be monitored as a measurement of abscess resolution.

  5. Duration of drain

    Time frame: From the drain placement until 1 month follow up

    The total duration of the drain placement will be recorded in days starting from the day of placement up to drain removal and monitored as a effectiveness of the intervention.

Study contacts

Contact information is provided by the study sponsor or research team.

Linda Ahrens

CONTACT

[email protected]

319-353-8435

Thomas Granchi, MD

CONTACT

[email protected]

319-356-1339

Sponsors and collaborators

Lead sponsor

Paolo Goffredo

Other

Registry information

Acronym: AID

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Mar 26, 2018
Registry last updated
Jun 6, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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