Antibiotic Irrigations for Intra-Abdominal Drains

NCT03476941 | Recruiting Phase 2 FDA Drug

• 1 other identifier: 201703759
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Abdominal Abscess

Outcome Measures

Primary Outcomes (1)

• Duration of systemic antibiotics

  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.

  From initiation of systemic treatment until 1 month follow up

Secondary Outcomes (5)

• White Blood Count

  From initiation of systemic treatment until 1 month follow up

• Change in temperature

  From initiation of systemic treatment until 1 month follow up

• Changes in size of the Abscess

  From patient initial hospitalization up to 1 month follow up

• Changes in Drain Output

  From the drain placement up to 1 month follow up

• Duration of drain

  From the drain placement until 1 month follow up

Study Arms (2)

Antibiotic Irrigation

EXPERIMENTAL

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; Drug: Clindamycin phosphate 6 mg/1ml for injection

Normal Saline Irrigation

PLACEBO COMPARATOR

The drain will be irrigated twice/day with normal saline

Other: Placebo

Interventions

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.

Antibiotic Irrigation

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.

Antibiotic Irrigation

Placebo OTHER

The placebo group will receive drain irrigation twice/day

Normal Saline Irrigation

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Intra-abdominal abscess drained with catheter/drain
• Treatment with systemic antibiotics
• Able to consent

You may not qualify if:

• Abscess(es) not amendable for an image guided drain placement.

Sponsors & Collaborators

• Paolo Goffredo: lead

Study Sites (1)

The University of Iowa

Iowa City, Iowa, 52242, United States

RECRUITING

Related Publications (4)

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

MeSH Terms

Conditions

Abdominal Abscess

Interventions

Injections; clindamycin phosphate

Condition Hierarchy (Ancestors)

Abscess; Suppuration; Infections

Intervention Hierarchy (Ancestors)

Drug Administration Routes; Drug Therapy; Therapeutics

Study Officials

• Paolo Goffredo, MD

  University of Iowa

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Thomas Granchi, MD

CONTACT

319-356-1339; thomas-granchi@uiowa.edu

Linda Ahrens

CONTACT

319-353-8435; linda-ahrens@uiowa.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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.

Study Record Dates

• First Submitted: August 9, 2017
• First Posted: March 26, 2018
• Study Start: April 1, 2019
• Primary Completion: May 1, 2021
• Study Completion: September 1, 2021
• Last Updated: June 6, 2019

Record last verified: 2019-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)