AID: Antibiotic Irrigations for Intra-Abdominal Drains
Study Details
Study Description
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 |
|---|---|---|
|
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.
Study Design
Arms and Interventions
| 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
|
Outcome Measures
Primary Outcome Measures
- Duration of systemic antibiotics [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
- White Blood Count [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.
- Change in temperature [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.
- Changes in size of the Abscess [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.
- Changes in Drain Output [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.
- Duration of drain [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.
Eligibility Criteria
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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | The University of Iowa | Iowa City | Iowa | United States | 52242 |
Sponsors and Collaborators
- Paolo Goffredo
Investigators
- Principal Investigator: Paolo Goffredo, MD, University of Iowa
Study Documents (Full-Text)
None provided.More Information
Publications
- 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.
- 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.
- 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.
- 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.
- 201703759