RADA16 on Mastoid Cavity Epithelialization
ConditionDelayed Wound Healing
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Florida
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
History of chronic immunodeficiency and autoimmune disease
History of head and neck radiation
Active tobacco use
History of coronary artery disease
Trial design
Design model
Parallel
Treatments tested in this trial
RADA16 gel application into mastoid cavity
DeviceA 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.
Treatment groups
14 Participants
are divided into 2 treatment groupsGroup A: RADA16 GroupExperimental treatment 1 intervention
Group B: Control GroupNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
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.
Time frame
Baseline and Postoperative Month 12
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.
Time frame
Baseline and Postoperative Month 23
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.
Time frame
Baseline and Postoperative Month 34
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.
Time frame
Baseline and Postoperative Month 6Secondary outcomes
1
Total Number of Medications Prescribed Up To Complete Epithelialization
The total number of medications prescribed postoperatively to promote mastoid cavity healing will be assessed with focus on antibiotics and steroids.
Time frame
Baseline to complete epithelialization, up to 2 years2
Total Number of Mastoid Cavity Debridements Up to Complete Epithelialization
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.
Time frame
Baseline to complete epithelialization, up to 2 years3
Total Number of Postoperative Visits Up to Complete Epithelialization
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.
Time frame
Baseline to complete epithelialization, up to 2 yearsLocations
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
University of Florida
Lead sponsor
3-D Matrix UK Ltd.
Collaborator
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: