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Antibiotic Irrigations for Intra-Abdominal Drains (AID)

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ClinicalTrials.gov Identifier: NCT03476941
Recruitment Status : Recruiting
First Posted : March 26, 2018
Last Update Posted : June 6, 2019
Sponsor:
Information provided by (Responsible Party):
Paolo Goffredo, University of Iowa

Brief 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.

Condition or disease Intervention/treatment Phase
Abdominal Abscess Drug: Gentamicin Sulfate Inj 20mg/2ml vial for injection Drug: Clindamycin phosphate 6 mg/1ml for injection Other: Placebo Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
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.
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.
Primary Purpose: Treatment
Official Title: Antibiotic Irrigations for Intra-Abdominal Drains
Actual Study Start Date : April 1, 2019
Estimated Primary Completion Date : May 1, 2021
Estimated Study Completion Date : September 1, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Abscess Antibiotics

Arm Intervention/treatment
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




Primary Outcome Measures :
  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 Outcome Measures :
  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.



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03476941


Contacts
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Contact: Thomas Granchi, MD 319-356-1339 thomas-granchi@uiowa.edu
Contact: Linda Ahrens 319-353-8435 linda-ahrens@uiowa.edu

Locations
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United States, Iowa
The University of Iowa Recruiting
Iowa City, Iowa, United States, 52242
Contact: John Keller    319-335-2123    dsp@uiowa.edu   
Principal Investigator: Paolo Goffredo, MD         
Sub-Investigator: Thomas Granchi, MD         
Sponsors and Collaborators
Paolo Goffredo
Investigators
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Principal Investigator: Paolo Goffredo, MD University of Iowa

Publications:
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Responsible Party: Paolo Goffredo, Principal Investigator, University of Iowa
ClinicalTrials.gov Identifier: NCT03476941     History of Changes
Other Study ID Numbers: 201703759
First Posted: March 26, 2018    Key Record Dates
Last Update Posted: June 6, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: At this point, there is no IPD sharing plan and not included in the consent process.

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes

Additional relevant MeSH terms:
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Abdominal Abscess
Abscess
Suppuration
Infection
Anti-Bacterial Agents
Clindamycin
Gentamicins
Clindamycin phosphate
Clindamycin palmitate
Antibiotics, Antitubercular
Anti-Infective Agents
Antitubercular Agents
Protein Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action