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RADA16 on Mastoid Cavity Epithelialization

NCT06698419 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 14

Last updated 2024-11-21

No results posted yet for this study

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

Interventions

DEVICE

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.

Sponsors & Collaborators

  • 3-D Matrix UK Ltd.

    collaborator INDUSTRY

  • University of Florida

    lead OTHER

Principal Investigators

  • Rex Haberman, MD · University of Florida

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-01-01
Primary Completion
2026-01-01
Completion
2027-01-01
FDA Device
Yes

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06698419 on ClinicalTrials.gov