A Phase 1/2 interventional study of Catheter Sclerotherapy in Abdominal Abscess, sponsored by University of Alabama at Birmingham. Active, not recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-24.
Sponsored by University of Alabama at Birmingham · Phase 1/2, Interventional, and Treatment
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.
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.
31 studies on the registry are indexed under Abdominal Abscess; 5 are open to participants now.
This study's planned enrollment of 60 is below the median of 105 across 24 interventional studies indexed under Abdominal Abscess.
Browse Abdominal Abscess studies →University of Alabama at Birmingham is the lead sponsor of 1,421 studies on the registry; 277 are open to participants now.
Of its 164 completed or terminated interventional studies of FDA-regulated products, 130 (79%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Catheter-based drainage and povidone iodine sclerotherapy of non-fistulous intraabdominal abscesses.
Drug: Catheter Sclerotherapy
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.
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
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
Plan to share: No
No publications or documents are linked to this record.
Started Dec 2025 (actual). Primary completion is estimated for Jul 2028, 31 months after the start.
How these figures are worked out, and which studies are left out of them.
This study is active, not recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
University of Alabama at Birmingham →