CompletedNot Applicable

Nasal Septal Flap for Donor Site Reconstruction

47 participantsStarted 2014-11-13

Plain-language summary

The purpose of this study is to demonstrate the utility of porcine small intestinal submucosa (SIS) as a graft material that may aid in the natural healing process of freshly exposed bone and cartilage in the nasal cavity.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Elective transnasal endoscopic skull base surgery where closure with a large nasoseptal flap (NSF) is anticipated (exposure of \>75% of the ipsilateral nasal septum bone/cartilage) * Patients without nutritional compromise or otherwise debilitated * Patients who are able to consent for themselves Exclusion Criteria: * Bilateral nasoseptal flap (NSF) placement in the same operative setting * Patients without significant bone/cartilage exposure to incorporate an intact 2x3 cm graft * Patients requiring 24 hour supplemental oxygen via nasal cannula * Patients who cannot consent for themselves

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Mean Change in Post-operative Remucosalization at the Donor Site

Timeframe: 2 weeks, 6 weeks, 12 weeks

Mean Change in Post-operative Locoregional Crusting at Donor Site

Timeframe: 2 weeks, 6 weeks, 12 weeks

Mean Change in Post-operative Edema at the Donor Site

Timeframe: 2 weeks, 6 weeks, 12 weeks

Trial details

NCT IDNCT03159624

SponsorUniversity of Alabama at Birmingham

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2016-03-21

Results submitted2019-03-04

View on ClinicalTrials.gov More Nasal Septum Perforation trials

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.