RADA16 on Mastoid Cavity Epithelialization

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Florida

About this trial

The goal of this clinical trial is to see if the application of RADA16 gel can expedite and improve the healing process in participants after canal wall down mastoidectomy. The main questions are:

* Does application of RADA16 in the mastoid cavity after canal wall down mastoidectomy lead to faster healing (i.e. epithelialization)? * Is application of RADA16 in the mastoid cavity after canal wall down mastoidectomy associated with a decreased need for medications after surgery (i.e. antibiotics, steroids), less frequent in-office debridements, and less postoperative appointments?

Researchers will compare the healing outcomes in participants treated with RADA16 gel to those in a control group who do not receive the treatment.

Participants will:

* Undergo canal wall down mastoidectomy as recommended regardless of participation in the clinical trial * Follow-up postoperatively for clinical assessment at 1 month, 2 months, 3 months, 6 months, 1 year, 18 months, and 2 years. Participants may follow-up more frequently as needed.

Eligibility criteria

Qualifiers

English-speaking adults over the age of 18 years who require a canal wall down mastoidectomy for any reason including cholesteatoma, chronic suppurative middle ear disease, and neoplasm.

Participants with history of canal wall up mastoidectomy who now require canal wall down mastoidectomy for any reason.

Disqualifiers

History of chronic immunodeficiency and autoimmune disease

History of head and neck radiation

Active tobacco use

History of coronary artery disease

Trial design

Treatments tested in this trial

  • RADA16 gel application into mastoid cavity

Treatment groups

14 Participants
are divided into 2 treatment groups

Locations

This trial has no locations

Sponsors and collaborators

University of Florida

Lead sponsor

3-D Matrix UK Ltd.

Collaborator