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RADA16 on Mastoid Cavity Epithelialization
Sponsor: University of Florida
Summary
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.
Official title: A Prospective Study: The Effect of RADA16 on Mastoid Cavity Epithelialization After Canal Wall Down Mastoidectomy
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
14
Start Date
2025-01-01
Completion Date
2027-01-01
Last Updated
2024-11-21
Healthy Volunteers
No
Conditions
Interventions
RADA16 gel application into mastoid cavity
A single application of RADA16 gel will be applied along the surface of the mastoid cavity intraoperatively prior to insertion of gelatin sponge packing. Application will involve a thin layer of gel just enough to cover the entire surface of the cavity.