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Completed

NCT Number: NCT03159624

Nasal Septal Flap for Donor Site Reconstruction

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.

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Key information

Conditions

Nasal Septum Perforation Nasal Septal Perforation Nose Diseases Otorhinolaryngologic Diseases Respiratory Tract Diseases Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Biodesign™ SIS graft

Other

2x3 cm Biodesign™ SIS perforated mesentery graft

Doyle silastic sheet

Other

Doyle silastic sheet

Primary outcomes

  1. Mean Change in Post-operative Remucosalization at the Donor Site

    Time frame: 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.

  2. Mean Change in Post-operative Locoregional Crusting at Donor Site

    Time frame: 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.

  3. Mean Change in Post-operative Edema at the Donor Site

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

University of Alabama at Birmingham

Other

Collaborators

  • Cook Group Incorporated
  • Stanford University

Registry information

Official study 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

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
May 19, 2017
Registry last updated
Jun 28, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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