RADA16 on Mastoid Cavity Epithelialization

Launched by UNIVERSITY OF FLORIDA · Nov 18, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a gel called RADA16 to see if it can help speed up the healing of the ear after a specific type of surgery known as canal wall down mastoidectomy. The main goal is to find out if using RADA16 can help the wound heal faster and reduce the need for medications like antibiotics or steroids, as well as fewer follow-up visits to the doctor. Researchers will compare patients who receive the RADA16 gel to those who do not receive any treatment to see which group heals better.

To be eligible for this trial, participants must be adults over 18 who need a canal wall down mastoidectomy for reasons like chronic ear infections or growths in the ear. They should be able to speak English and must meet certain health criteria, meaning they cannot have certain medical conditions or allergies. If someone joins the study, they can expect to have regular follow-up appointments for up to two years to monitor their healing progress. It's important to note that the trial has not started recruiting participants yet, so there will be more information available once it begins.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 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.
• Exclusion Criteria:
• • 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