Antibiotic Irrigations for Intra-Abdominal Drains

Abdominal Abscess Clinical Trial

— AID  

Official title:

Antibiotic Irrigations for Intra-Abdominal Drains

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03476941
• Other study ID #: 201703759
• Status: Recruiting
• Phase: Phase 2
• Start date: April 1, 2019
• Est. completion date: September 1, 2021

Study information

• Verified date: June 2019
• Source: University of Iowa
• Contact: Thomas Granchi, MD
• Phone: 319-356-1339
• Email: thomas-granchi[@]uiowa.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: September 1, 2021
• Est. primary completion date: May 1, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Abdominal Abscess

Intervention

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.
• 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

Locations

Country	Name	City	State
United States	The University of Iowa	Iowa City	Iowa

Sponsors (1)

Lead Sponsor	Collaborator
Paolo Goffredo

Country where clinical trial is conducted

United States, 

References & Publications (4)

Sauermann R, Feurstein T, Karch R, Kjellsson MC, Jäger W, Böhmdorfer M, Püspök 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. — View Citation

Sauermann R, Karch R, Kjellsson MC, Feurstein T, Püspök A, Langenberger H, Böhmdorfer M, Jäger 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	White Blood Count	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.	From initiation of systemic treatment until 1 month follow up
Secondary	Change in temperature	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.	From initiation of systemic treatment until 1 month follow up
Secondary	Changes in size of the Abscess	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.	From patient initial hospitalization up to 1 month follow up
Secondary	Changes in Drain Output	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.	From the drain placement up to 1 month follow up
Secondary	Duration of drain	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.	From the drain placement until 1 month follow up