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
Locations
Sponsors and collaborators
University of Florida
Lead sponsor
3-D Matrix UK Ltd.
Collaborator