Nasal Septal Flap for Donor Site Reconstruction

Study Overview
=================
Brief 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.

Detailed Description
-----------------
Patients who undergo endoscopic endonasal skull base surgery, and may require nasoseptal flap placement as part of skull base reconstruction, will be informed, consented and enrolled for participation. If the intraoperative decision is ultimately made for harvest and placement of full-length nasoseptal flap by each individual surgeon, patients will then be consecutively, sequentially randomized to use of either: Thin Doyle silastic sheet placement alone over the resulting exposed septum cartilage/bone (20 randomly assigned patients) 2x3 cm Biodesign™ SIS perforated mesentery graft surface placement plus overlying Doyle silastic sheet placement over the resulting exposed septum cartilage/bone. (20 randomly assigned patients) When used, Biodesign graft will be soaked in sterile saline out of the packaging, and placed as an intact single sheet over the exposed bone nasal septum bone/cartilage (without trimming). For uniformity and ease of future analysis, the bottom edge of the graft will be placed parallel to, and proximal to, the nasal floor cut edge remnant mucosal surface as possible. Except for a thin Doyle silastic sheet to cover the graft site, no additional reinforcement (suture/tissue glue) will be placed for those patients in the Biodesign graft arm. Time Points and Study Parameters: All enrolled patients will have Doyle silastic sheeting removed only at 2 weeks post-op. All patients will receive 250cc normal saline topical nasal rinses starting at 14 days until 120 days post-op. No topical irrigation additives (budesonide/mupirocin) will be administered over 12 weeks. All patients will be assessed at 2 weeks, 6 weeks and 12 weeks following randomization and entry into this study.

Official Title
-----------------
Use of Porcine Small Intestinal Submucosa (SIS) Graft to Aid in Nasal Septal Remucosalization and Tissue Healing in Patients Following Use of Nasoseptal Flap Elevation for Skull Base Surgery

Conditions
-----------------
Nasal Septum Perforation

Intervention / Treatment
-----------------
* Other: Biodesign™ SIS graft
* Other: Doyle silastic sheet


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment Group<br>2x3 cm Biodesign™ SIS graft placement + overlying Doyle silastic sheet placement over the resulting exposed septum cartilage/bone | Other: Biodesign™ SIS graft<br>* 2x3 cm Biodesign™ SIS perforated mesentery graft<br>Other: Doyle silastic sheet<br>* Doyle silastic sheet<br>|
| Active Comparator: Control Group<br>Thin Doyle silastic sheet placement alone over the resulting exposed septum cartilage/bone | Other: Doyle silastic sheet<br>* Doyle silastic sheet<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean Change in Post-operative Remucosalization at the Donor Site | Mean change as measured by Visual Analogue Scale (VAS) scores from 3 independent reviewers from endoscopy videos collected at 2, 6, and 12 weeks. The Visual Analogue Scale for mean change in post-operative remucosalization is a Likert scale ranging from 0% (no remucosalization) to 100% (complete remucosalization), with higher scores representing better healing. | 2 weeks, 6 weeks, 12 weeks | 
| Mean Change in Post-operative Locoregional Crusting at Donor Site | Mean change as measured by Visual Analogue Scale (VAS) scores from 3 independent reviewers from endoscopy videos collected at 2, 6, and 12 weeks. The Visual Analogue Scale for mean change in post-operative crusting is a Likert scale ranging from 0 (no crusting) to 10 (complete crusting), with lower scores representing better healing. | 2 weeks, 6 weeks, 12 weeks | 
| Mean Change in Post-operative Edema at the Donor Site | Mean change as measured by Visual Analogue Scale (VAS) scores from 3 independent reviewers from endoscopy videos collected at 2, 6, and 12 weeks. The Visual Analogue Scale for mean change in post-operative edema is a Likert scale ranging from 0 (no edema) to 10 (severe edema), with lower scores representing better healing. | 2 weeks, 6 weeks, 12 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
nasoseptal flap, tissue repair, wound healing, remucosalization, upper airway, granulation tissue, tissue graft