NCT03476941 · Paolo Goffredo
Antibiotic Irrigations for Intra-Abdominal Drains
(AID)
What this study is about
Intra-abdominal abscesses are pus-filled pouches in the abdominal cavity. Current the usual treatment 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.
View original scientific description
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.
Interventions
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.
OTHER
Placebo
The placebo group will receive drain irrigation twice/day
Primary outcome measures
Duration of systemic antibiotics
Time frame: 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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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.
Where
- Iowa City, Iowa
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jun 6, 2019 · Source of record for eligibility and locations