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Recruiting NCT03476941

Antibiotic Irrigations for Intra-Abdominal Drains

Phase II Interventional Abdominal Abscess

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Gentamicin Sulfate Inj 20mg/2ml vial for injection, Clindamycin phosphate 6 mg/1ml for injection, Placebo.
Who it may be relevant to
Registry conditions: Abdominal Abscess. Basic parameters: 18 years — 80 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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.

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.

Interventions

  • 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.
  • Other Placebo
    The placebo group will receive drain irrigation twice/day

Primary outcome measures

  • Duration of systemic antibiotics [Time frame: From initiation of systemic treatment until 1 month follow up]
Secondary outcome measures (5)
  • White Blood Count [Time frame: From initiation of systemic treatment until 1 month follow up]
  • Change in temperature [Time frame: From initiation of systemic treatment until 1 month follow up]
  • Changes in size of the Abscess [Time frame: From patient initial hospitalization up to 1 month follow up]
  • Changes in Drain Output [Time frame: From the drain placement up to 1 month follow up]
  • Duration of drain [Time frame: From the drain placement until 1 month follow up]

Eligibility 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

United States · 1 center
  • The University of Iowa — Iowa City

Publications

  • Yoon YI, Hwang S, Cho YJ, Ha TY, Song GW, Jung DH. Therapeutic effect of trans-drain administration of antibiotics in patients showing intractable pancreatic leak-associated pus drainage after pancreaticoduodenectomy. Korean J Hepatobiliary Pancreat Surg. 2015 Feb;19(1):17-24. doi: 10.14701/kjhbps.2015.19.1.17. Epub 2015 Feb 28. PMID 26155272
  • Sauermann R, Karch R, Kjellsson MC, Feurstein T, Puspok A, Langenberger H, Bohmdorfer M, Jager W, Zeitlinger M. Good penetration of moxifloxacin into human abscesses. Pharmacology. 2012;90(3-4):146-50. doi: 10.1159/000341550. Epub 2012 Aug 3. PMID 22868236
  • Sauermann R, Feurstein T, Karch R, Kjellsson MC, Jager W, Bohmdorfer M, Puspok A, Langenberger H, Wild T, Winkler S, Zeitlinger M. Abscess penetration of cefpirome: concentrations and simulated pharmacokinetic profiles in pus. Eur J Clin Pharmacol. 2012 Oct;68(10):1419-23. doi: 10.1007/s00228-012-1270-1. Epub 2012 Mar 23. PMID 22441316
  • Zimmerman LH, Tyburski JG, Glowniak J, Singla R, Lavery T, Nailor M, Stassinopoulus J, Hong K, Barshikar S, Dolman HS, Baylor AE, Wilson RF. Impact of evaluating antibiotic concentrations in abdominal abscesses percutaneously drained. Am J Surg. 2011 Mar;201(3):348-52; discussion 352. doi: 10.1016/j.amjsurg.2010.09.010. PMID 21367377

Identifiers

NCT: NCT03476941 · 201703759

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗