Clinical Trial: Nasal Septal Flap for Donor Site Reconstruction

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

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 Summary:

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
    Sponsor: University of Alabama at Birmingham

    Current Primary Outcome: Mean change in post-operative remucosalization, locoregional crusting, and edema at the donor site [ Time Frame: 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.


    Original Primary Outcome: Same as current

    Current Secondary Outcome:

    Original Secondary Outcome:

    Information By: University of Alabama at Birmingham

    Dates:
    Date Received: May 17, 2017
    Date Started: November 13, 2014
    Date Completion:
    Last Updated: May 17, 2017
    Last Verified: May 2017