Nasal Septal Flap for Donor Site Reconstruction

June 26, 2023 updated by: Brad Woodworth, MD, University of Alabama at Birmingham

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

47

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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 weeks, 6 weeks, 12 weeks
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.
2 weeks, 6 weeks, 12 weeks
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.
2 weeks, 6 weeks, 12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Alabama at Birmingham

Collaborators

Stanford University
Cook Group Incorporated

Investigators

  • Principal Investigator: Brad Woodworth, MD, University of Alabama at Birmingham

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 13, 2014

Primary Completion (Actual)

March 21, 2016

Study Completion (Actual)

March 21, 2016

Study Registration Dates

First Submitted

May 17, 2017

First Submitted That Met QC Criteria

May 17, 2017

First Posted (Actual)

May 19, 2017

Study Record Updates

Last Update Posted (Actual)

June 28, 2023

Last Update Submitted That Met QC Criteria

June 26, 2023

Last Verified

August 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • F140612003

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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