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Ear surgery packing gets a makeover: chitosan gel tested

NCT ID NCT04783233

Knowledge-focused Sponsor: Henry Ford Health System Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled This study
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study was designed to test a new gel made from chitosan (a substance from shellfish) as a packing material in ear surgery. The gel was to be compared with the standard Gelfoam packing to see which leads to better healing and less inflammation. However, the trial was withdrawn before any patients were enrolled, so no results are available.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
chitosan succinamide gel (Chitogel CSK-4)
What this could lead to
If successful, this could lead to a better packing material for ear surgery that improves healing and reduces inflammation.
What could go wrong
The trial was withdrawn before enrolling any participants, so no data were collected. It is unknown if the gel is safe or effective in humans for this use.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Started

Jan 2021

Finished

Nov 2021

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

Patients eligible for primary tympanoplasty surgery.

Ages

19 to 100 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Healthy adults * Single tympanic membrane perforation Exclusion Criteria: * Chronic recurrent infection or otorrhea * Previous ear surgery for the study ear * Shellfish allergy * Cerebral Spinal Fluid (CSF) leak concern

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As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Tympanoplasty surgery

Contacts and locations

Locations

  • Ascension Providence Hospital Novi Campus

    Novi, Michigan, 48374, United States

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