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NCT Number: NCT06906029

Abdominal aBscess Catheter Sclerotherapy (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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Catheter Sclerotherapy

Drug

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.

Primary outcomes

  1. Percentage of patients with VAS pain exceeding 7 following the catheter sclerotherapy or SIR grade 3 or higher complication.

    Time frame: Baseline to day 7 plus or minus 7 days

  2. Percentage of patients that will require reintervention for the same intrabdominal abscess within one week.

    Time frame: Baseline to day 7 plus or minus 7 days

Study contacts

Contact information is provided by the study sponsor or research team.

Evan Husdon, MS

CONTACT

[email protected]

205-934-6499

Sponsors and collaborators

Lead sponsor

University of Alabama at Birmingham

Other

Collaborators

  • Argon Medical Devices

Registry information

Acronym: ABCS

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Apr 2, 2025
Registry last updated
Jul 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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