RADA16 on Mastoid Cavity Epithelialization

NCT06698419 | Not Yet Recruiting FDA Device

• 1 other identifier: IRB202401064
• Study Type: interventional
• Target: 14
• Locations: 0 countries
• Sites: N/A

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)?
• 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.

Conditions

Delayed Wound Healing

Keywords

Mastoidectomy; Healing; Biologic; Mastoid cavity; Mastoid cavity disease

Outcome Measures

Primary Outcomes (7)

• Time to Complete Mastoid Cavity Epithelialization at 1 Month

  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 epithelialization.

  Baseline and Postoperative Month 1

• Time to Complete Mastoid Cavity Epithelialization at 2 Months

  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 epithelialization.

  Baseline and Postoperative Month 2

• Time to Complete Mastoid Cavity Epithelialization at 3 Months

  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 epithelialization.

  Baseline and Postoperative Month 3

• Time to Complete Mastoid Cavity Epithelialization at 6 Months

  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 epithelialization.

  Baseline and Postoperative Month 6

• Time to Complete Mastoid Cavity Epithelialization at 1 Year

  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 epithelialization.

  Baseline and Postoperative Year 1

• Time to Complete Mastoid Cavity Epithelialization at 18 Months

  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 epithelialization.

  Baseline and Postoperative Month 18

• Time to Complete Mastoid Cavity Epithelialization at 2 Years

  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 epithelialization.

  Baseline and Postoperative Year 2

Secondary Outcomes (3)

• Total Number of Medications Prescribed Up To Complete Epithelialization

  Baseline to complete epithelialization, up to 2 years

• Total Number of Mastoid Cavity Debridements Up to Complete Epithelialization

  Baseline to complete epithelialization, up to 2 years

• Total Number of Postoperative Visits Up to Complete Epithelialization

  Baseline to complete epithelialization, up to 2 years

Study Arms (2)

RADA16 Group

EXPERIMENTAL

Participants will undergo canal wall down mastoidectomy in standard fashion. All participants will have absorbable gelatin sponge placed into the mastoid cavity which is standard care. Only participants in this arm will receive RADA16 gel into the mastoid cavity before placement of the gelatin sponge.

Device: RADA16 gel application into mastoid cavity

Control Group

NO INTERVENTION

Participants will undergo canal wall down mastoidectomy in standard fashion. All participants will have absorbable gelatin sponge placed into the mastoid cavity which is standard care. Participants in this arm will not receive RADA16 gel.

Interventions

RADA16 gel application into mastoid cavity DEVICE

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.

Also known as: PuraGel

RADA16 Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Florida: lead
• 3-D Matrix UK Ltd.: collaborator

Related Publications (25)

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Study Officials

• Rex Haberman, MD

  University of Florida

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Braeden Lovett, MD

CONTACT

240-672-8082; braedenlovett@ufl.edu

Rex Haberman, MD

CONTACT

rex.haberman@ent.ufl.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: The surgeon/principal investigator performing the canal wall down mastoidectomy will be aware of participant allocation. Participants and research co-investigators will not be aware of patient allocation.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Participants will be randomly allocated to the experimental group or the control group. All participants will undergo a canal wall down mastoidectomy in standard fashion. Participants in the experimental group will receive RADA16 gel in the mastoid cavity at the conclusion of the surgery whereas participants in the control group will not.

Study Record Dates

• First Submitted: November 18, 2024
• First Posted: November 21, 2024
• Study Start: January 1, 2025
• Primary Completion: January 1, 2026
• Study Completion (Estimated): January 1, 2027
• Last Updated: November 21, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share