Actively Recruiting

Phase 2
Age: 18Years - 80Years
All Genders
Healthy Volunteers
ID03476941

Antibiotic Irrigations for Intra-Abdominal Drains

Led by Paolo Goffredo · Updated on 2019-06-06

50

Participants Needed

1

Research Sites

17 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Eligible

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
Not Eligible

You will not qualify if you...

  • Abscess(es) not suitable for image-guided drain placement

AI-Screening

AI-Powered Screening

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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

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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

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Published Research Related To This Trial

Therapeutic effect of trans-drain administration of antibiotics in patients showing intractable pancreatic leak-associated pus drainage after pancreaticoduodenectomy.

Young-In Yoon, Shin Hwang, Yu-Jeong Cho...

https://pubmed.ncbi.nlm.nih.gov/26155272