RADA16 on Mastoid Cavity Epithelialization
- Conditions
- Registration Number
- NCT06698419
- Lead Sponsor
- University of Florida
- Brief 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)?
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- Detailed Description
Canal wall-down mastoidectomy is a commonly performed procedure for the treatment of cholesteatoma and chronic otitis media which involves elimination of the posterior wall of the external auditory canal and creation of a mastoid cavity. Unlike its canal wall-up counterpart, canal wall-down mastoidectomy allows for exteriorization and removal of cholesteatom...
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 14
- 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.
- History of chronic immunodeficiency and autoimmune disease
- History of head and neck radiation
- Active tobacco use
- History of coronary artery disease
- History of peripheral vascular disease
- History of diabetes mellitus
- Known allergy to RADA16 gel or its components
- Vulnerable populations including children, neonates, pregnant women, prisoners, institutionalized individuals, and other individuals who are unable to provide informed consent
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Time to Complete Mastoid Cavity Epithelialization at 1 Month Baseline and Postoperative Month 1 The mastoid cavity will be evaluated postoperatively using an operative microscope. The principal investigator will record the otoscopic exam which will be saved as a digital file on a password-secured server. Two separate investigators who are masked to participant arm allocation will view the recorded exam and evaluate the mastoid cavity for complete epith...
Time to Complete Mastoid Cavity Epithelialization at 2 Months Baseline and Postoperative Month 2 The mastoid cavity will be evaluated postoperatively using an operative microscope. The principal investigator will record the otoscopic exam which will be saved as a digital file on a password-secured server. Two separate investigators who are masked to participant arm allocation will view the recorded exam and evaluate the mastoid cavity for complete epith...
Time to Complete Mastoid Cavity Epithelialization at 3 Months Baseline and Postoperative Month 3 The mastoid cavity will be evaluated postoperatively using an operative microscope. The principal investigator will record the otoscopic exam which will be saved as a digital file on a password-secured server. Two separate investigators who are masked to participant arm allocation will view the recorded exam and evaluate the mastoid cavity for complete epith...
Time to Complete Mastoid Cavity Epithelialization at 6 Months Baseline and Postoperative Month 6 The mastoid cavity will be evaluated postoperatively using an operative microscope. The principal investigator will record the otoscopic exam which will be saved as a digital file on a password-secured server. Two separate investigators who are masked to participant arm allocation will view the recorded exam and evaluate the mastoid cavity for complete epith...
Time to Complete Mastoid Cavity Epithelialization at 1 Year Baseline and Postoperative Year 1 The mastoid cavity will be evaluated postoperatively using an operative microscope. The principal investigator will record the otoscopic exam which will be saved as a digital file on a password-secured server. Two separate investigators who are masked to participant arm allocation will view the recorded exam and evaluate the mastoid cavity for complete epith...
Time to Complete Mastoid Cavity Epithelialization at 18 Months Baseline and Postoperative Month 18 The mastoid cavity will be evaluated postoperatively using an operative microscope. The principal investigator will record the otoscopic exam which will be saved as a digital file on a password-secured server. Two separate investigators who are masked to participant arm allocation will view the recorded exam and evaluate the mastoid cavity for complete epith...
Time to Complete Mastoid Cavity Epithelialization at 2 Years Baseline and Postoperative Year 2 The mastoid cavity will be evaluated postoperatively using an operative microscope. The principal investigator will record the otoscopic exam which will be saved as a digital file on a password-secured server. Two separate investigators who are masked to participant arm allocation will view the recorded exam and evaluate the mastoid cavity for complete epith...
- Secondary Outcome Measures
Name Time Method Total Number of Medications Prescribed Up To Complete Epithelialization Baseline to complete epithelialization, up to 2 years The total number of medications prescribed postoperatively to promote mastoid cavity healing will be assessed with focus on antibiotics and steroids.
Total Number of Mastoid Cavity Debridements Up to Complete Epithelialization Baseline to complete epithelialization, up to 2 years The total number of in-office mastoid cavity debridements will be recorded and assessed. Participants with faster and more robust healing are expected to require less in-office debridements.
Total Number of Postoperative Visits Up to Complete Epithelialization Baseline to complete epithelialization, up to 2 years The total number of postoperative visits (including set time points at 1 month, 2 months, 3 months, 9 months, 1 year, 18 months, and 2 years) will be recorded and assessed. Participants with faster and more robust healing are expected to not need additional visits, specifically for mastoid cavity healing related problems.