Clinical trial NCT03476941: Antibiotic Irrigations for Intra-Abdominal Drains
Official title: Antibiotic Irrigations for Intra-Abdominal Drains
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Abdominal Abscess
Lead sponsor: University of Iowa
Sponsor class: OTHER
First posted: 2018-03-26
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
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

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.

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.

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.

Primary outcomes:
measure: Duration of systemic antibiotics
timeFrame: From initiation of systemic treatment until 1 month follow up
Secondary outcomes:
measure: White Blood Count
timeFrame: From initiation of systemic treatment until 1 month follow up
measure: Change in temperature
timeFrame: From initiation of systemic treatment until 1 month follow up
measure: Changes in size of the Abscess
timeFrame: From patient initial hospitalization up to 1 month follow up
measure: Changes in Drain Output
timeFrame: From the drain placement up to 1 month follow up
measure: Duration of drain
timeFrame: From the drain placement until 1 month follow up
Other outcomes:
Locations:
city: Iowa City
country: United States
facility: The University of Iowa
state: Iowa
Study officials:
affiliation: University of Iowa
name: Paolo Goffredo, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.