Nasal Septal Flap for Donor Site Reconstruction

Not Applicable

Completed

• Conditions: Nasal Septum Perforation
• Interventions: Other: Biodesign™ SIS graft; Other: Doyle silastic sheet

• Registration Number: NCT03159624
• Lead Sponsor: University of Alabama at Birmingham

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.

Study Timeline

• Study Start: 2014-11-13
• Primary Completion: 2016-03-21
• Study Completion: 2016-03-21
• Study First Submitted: 2017-05-17
• Study First Submitted QC: 2017-05-17
• Study First Posted: 2017-05-19
• Results First Submitted: 2019-03-04
• Status Verified: 2019-08
• Results First Submitted QC: 2019-08-13
• Results First Posted: 2019-09-16
• Last Update Submitted: 2023-06-26
• Last Update Posted: 2023-06-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 47

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Treatment Group	Doyle silastic sheet	2x3 cm Biodesign™ SIS graft placement + overlying Doyle silastic sheet placement over the resulting exposed septum cartilage/bone
Treatment Group	Biodesign™ SIS graft	2x3 cm Biodesign™ SIS graft placement + overlying Doyle silastic sheet placement over the resulting exposed septum cartilage/bone
Control Group	Doyle silastic sheet	Thin Doyle silastic sheet placement alone over the resulting exposed septum cartilage/bone

Primary Outcome Measures

Name	Time	Method
Mean Change in Post-operative Locoregional Crusting at Donor Site	2 weeks, 6 weeks, 12 weeks	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.
Mean Change in Post-operative Remucosalization at the Donor Site	2 weeks, 6 weeks, 12 weeks	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.
Mean Change in Post-operative Edema at the Donor Site	2 weeks, 6 weeks, 12 weeks	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.