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 range18 Years

SexALL

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

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