Abdominal aBscess Catheter Sclerotherapy (ABCS) (ABCS)

This is a single center, two arm phase I/II clinical trial exploring the use of chemical sclerosants (ethanol and povidone iodine) in decreasing the time needed for catheter drainage for patients with non-fistulous intraabdominal abscesses. The target study sample size is 60 patients, 30 in each arm and abscess size is to be a minimum of 3cm in all 3 dimensions. The primary outcomes of interest will be tolerability and need for catheter reinsertion by one week post intervention.

Study Overview

• Status: Not yet recruiting
• Conditions: Abdominal Abscess
• Intervention / Treatment: Drug: Catheter Sclerotherapy

Detailed Description

This is a two-arm prospective phase I/II clinical trial to assess the safety of a protocol of catheter-based drainage and povidone iodine or ethanol sclerotherapy of non-fistulous intraabdominal abscesses. The study aims to enroll approximately 60 total subjects with 30 per arm. The abscess should be intraperitoneal with a minimum diameter of 3cm in all three dimensions and devoid of suspicion for relation to a fistula. The described technique above will be employed to place a drainage catheter of minimum 14F in caliber and obtain an antimicrobial sample. Saline lavage will be performed by irrigating the abscess and aspirating the contents until the character of the instilled and aspirated fluid are similar. Following this step the cavity will be drained in full and a volume of approximately equal to the cavity of povidone iodine or ethanol will be instilled through the catheter with the catheter turned off to drainage. After approximately two minutes the drain will be opened to gravity and two minutes of additional time will be allotted to drain any excess povidone iodine or ethanol. The catheter will then be removed, and the site dressed with gauze and film dressing. The patient will then be followed clinically in the hospital for at least 48 hours and by phone check in for 7 days.

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Phase 2; Phase 1

Contacts and Locations

• Study Contact: Name: Evan Husdon, MS; Phone Number: 205-934-6499; Email: evanhudson@uabmc.edu

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States, 35294
      • University of Alabama at Birmingham
      • Contact: Evan Hudson; Phone Number: 205-934-6499; Email: evanhudson@uabmc.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Male or female, aged over 18years
• Cross-sectional imaging (CT, US, MRI) showing an intraabdominal abscess measuring at last 3cm in each dimension without fistula to the bowel or skin.
• Provision of signed and dated informed consent form
• Stated willingness to comply with all study procedures and availability for the duration of the study

Exclusion Criteria:

• Pregnancy or lactation
• Known allergic reactions to povidone iodine or ethanol
• Hemodynamic instability

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Iodine Arm; Catheter-based drainage and povidone iodine sclerotherapy of non-fistulous intraabdominal abscesses.	Drug: Catheter Sclerotherapy; Place a drainage catheter of minimum 14F in caliber and obtain an antimicrobial sample. Saline lavage will be performed by irrigating the abscess and aspirating the contents until the character of the instilled and aspirated fluid are similar. Following this step the cavity will be drained in full and a volume of approximately equal to the cavity of povidone iodine or ethanol will be instilled through the catheter with the catheter turned off to drainage. After approximately two minutes the drain will be opened to gravity and two minutes of additional time will be allotted to drain any excess povidone iodine or ethanol. The catheter will then be removed, and the site dressed with gauze and film dressing. The patient will then be followed clinically in the hospital for at least 48 hours and by phone check in for 7 days.
Active Comparator: Ethanol Arm; Catheter-based drainage and ethanol sclerotherapy of non-fistulous intraabdominal abscesses.	Drug: Catheter Sclerotherapy; Place a drainage catheter of minimum 14F in caliber and obtain an antimicrobial sample. Saline lavage will be performed by irrigating the abscess and aspirating the contents until the character of the instilled and aspirated fluid are similar. Following this step the cavity will be drained in full and a volume of approximately equal to the cavity of povidone iodine or ethanol will be instilled through the catheter with the catheter turned off to drainage. After approximately two minutes the drain will be opened to gravity and two minutes of additional time will be allotted to drain any excess povidone iodine or ethanol. The catheter will then be removed, and the site dressed with gauze and film dressing. The patient will then be followed clinically in the hospital for at least 48 hours and by phone check in for 7 days.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Percentage of patients with VAS pain exceeding 7 following the catheter sclerotherapy or SIR grade 3 or higher complication.	Baseline to day 7 plus or minus 7 days
Percentage of patients that will require reintervention for the same intrabdominal abscess within one week.	Baseline to day 7 plus or minus 7 days

Collaborators and Investigators

• Sponsor: University of Alabama at Birmingham
• Collaborators: Argon Medical Devices
• Investigators: Principal Investigator: Junaid Raja, MD, MSPH, FACP, University of Alabama at Birmingham

Study record dates

Study Major Dates

• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): July 1, 2028
• Study Completion (Estimated): July 1, 2028

Study Registration Dates

• First Submitted: March 19, 2025
• First Submitted That Met QC Criteria: March 28, 2025
• First Posted (Actual): April 2, 2025

Study Record Updates

• Last Update Posted (Actual): July 11, 2025
• Last Update Submitted That Met QC Criteria: July 8, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Inflammation; Suppuration; Abscess; Abdominal Abscess
• Other Study ID Numbers: IRB-300014540; 000548435 (Other Grant/Funding Number: Argon Medical Devices Inc.)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes