N/A
N=47
Nasal Septal Flap for Donor Site Reconstruction
Nasal Septum Perforation
Bottom Line
View on ClinicalTrials.gov: NCT03159624 ↗Enrolled (actual)
47
Serious AEs
0.0%
Results posted
Sep 2019
Primary outcome: Primary: Mean Change in Post-operative Remucosalization at the Donor Site — 47.8; 37.8; 49.7; 43.5 percentage of remucosalization
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Biodesign™ SIS graft (Other); Doyle silastic sheet (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Alabama at Birmingham
- Primary completion
- Mar 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Change in Post-operative Remucosalization at the Donor Site |
47.8; 37.8; 49.7; 43.5; 73.9; 65.3 | — |
| PRIMARY Mean Change in Post-operative Locoregional Crusting at Donor Site |
3.50; 4.22; 4.22; 5.2; 2.64; 2.92 | — |
| PRIMARY Mean Change in Post-operative Edema at the Donor Site |
3.34; 3.52; 3.25; 3.15; 2.26; 2.65 | — |
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT03159624). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.