Antibiotic Irrigations for Intra-Abdominal Drains
- Conditions
- Abdominal Abscess
- Interventions
- Registration Number
- NCT03476941
- Lead Sponsor
- Paolo Goffredo
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 50
- Intra-abdominal abscess drained with catheter/drain
- Treatment with systemic antibiotics
- Able to consent
- Abscess(es) not amendable for an image guided drain placement.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Antibiotic Irrigation Clindamycin phosphate 6 mg/1ml for injection The drain will be irrigated twice/day with the above antibiotic solution for 7 days maximum Antibiotic Irrigation Gentamicin Sulfate Inj 20mg/2ml vial for injection The drain will be irrigated twice/day with the above antibiotic solution for 7 days maximum Normal Saline Irrigation Placebo The drain will be irrigated twice/day with normal saline
- Primary Outcome Measures
Name Time Method 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
Name Time Method 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.
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.
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.
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.
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.
Trial Locations
- Locations (1)
The University of Iowa
🇺🇸Iowa City, Iowa, United States