This trial investigates treatment approaches for people with intra-abdominal abscesses, which are collections of pus inside the abdominal cavity. The study evaluates the clinical effects of irrigating the abscess drain with a higher local concentration of antibiotics compared to the standard practice of using normal saline. This research is conducted as a Phase 2 randomized trial to better understand how local antibiotic irrigation might impact recovery.
Participants will be randomly assigned to one of two groups. One group will have their surgical drains irrigated twice daily with an antibiotic solution containing Gentamicin and/or Clindamycin for up to 7 days or until the drain is removed. The other group will receive drain irrigation twice daily with normal saline as a placebo. The antibiotic dosages are specified as 5 mg Gentamicin in 10 ml volume twice daily and 12 mg Clindamycin in 10 ml once daily.
Throughout the study and up to one month after starting systemic antibiotic treatment, researchers will monitor several outcomes including the duration of systemic antibiotic use, white blood cell count, body temperature changes, abscess size, drain output, and how long the drain remains in place. Participants will receive standard systemic antibiotics and will be followed during hospitalization and after discharge to assess these measurements.
CONDITIONS
Brief Title
Antibiotic Irrigations for Intra-Abdominal Drains
Who Can Participate
Age: 18Years - 80Years
All Genders
Healthy Volunteers
Eligibility Criteria
You may qualify if you...
Have an intra-abdominal abscess drained with a catheter or drain
Currently receiving systemic antibiotic treatment
Able to provide informed consent
You will not qualify if you...
Abscess(es) not suitable for image-guided drain placement
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Treatment
Duration - Up to 7 days or until drain removal
Participants receive drain irrigation twice daily with either antibiotic solution or normal saline for up to 7 days or until the drain is removed if earlier.
Twice daily visits for drain irrigation
Follow-up
Duration - Up to 1 month
Participants are monitored for outcomes including antibiotic duration, white blood count, temperature changes, abscess size, drain output, and drain duration for up to 1 month after treatment.
Approximately 4 follow-up visits
Trial Site Locations
Total: 1 location
1
The University of Iowa
Iowa City, Iowa, United States, 52242
Actively Recruiting
Loading map...
Research Team
T
Thomas Granchi, MD
L
Linda Ahrens
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match. Sign up to get personalized trial recommendations delivered to your inbox.
Therapeutic effect of trans-drain administration of antibiotics in patients showing intractable pancreatic leak-associated pus drainage after pancreaticoduodenectomy.