NCT03159624

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
47

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2014

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 13, 2014

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 21, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 21, 2016

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

May 17, 2017

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 19, 2017

Completed
2.3 years until next milestone

Results Posted

Study results publicly available

September 16, 2019

Completed
Last Updated

June 28, 2023

Status Verified

August 1, 2019

Enrollment Period

1.4 years

First QC Date

May 17, 2017

Results QC Date

March 4, 2019

Last Update Submit

June 26, 2023

Conditions

Nasal Septum Perforation

Keywords

nasoseptal flaptissue repairwound healingremucosalizationupper airwaygranulation tissuetissue graft

Outcome Measures

Primary Outcomes (3)

  • 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

Study Arms (2)

Treatment Group

EXPERIMENTAL

2x3 cm Biodesign™ SIS graft placement + overlying Doyle silastic sheet placement over the resulting exposed septum cartilage/bone

Other: Biodesign™ SIS graftOther: Doyle silastic sheet

Control Group

ACTIVE COMPARATOR

Thin Doyle silastic sheet placement alone over the resulting exposed septum cartilage/bone

Other: Doyle silastic sheet

Interventions

Biodesign™ SIS graftOTHER

2x3 cm Biodesign™ SIS perforated mesentery graft

Treatment Group
Doyle silastic sheetOTHER

Doyle silastic sheet

Control GroupTreatment Group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Nayak JV, Rathor A, Grayson JW, Bravo DT, Velasquez N, Noel J, Beswick DM, Riley KO, Patel ZM, Cho DY, Dodd RL, Thamboo A, Choby GW, Walgama E, Harsh GR, Hwang PH, Clemons L, Lowman D, Richman JS, Woodworth BA. Porcine small intestine submucosal grafts improve remucosalization and progenitor cell recruitment to sites of upper airway tissue remodeling. Int Forum Allergy Rhinol. 2018 Oct;8(10):1162-1168. doi: 10.1002/alr.22156. Epub 2018 Jun 1.

    PMID: 29856526DERIVED

MeSH Terms

Conditions

Nasal Septal Perforation

Condition Hierarchy (Ancestors)

Nose DiseasesRespiratory Tract DiseasesOtorhinolaryngologic DiseasesWounds and Injuries

Results Point of Contact

Title
Dr. Brad Woodworth
Organization
University of Alabama at Birmingham
bwoodworth@uabmc.edu
205-801-7858

Study Officials

  • Brad Woodworth, MD

    University of Alabama at Birmingham

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

May 17, 2017

First Posted

May 19, 2017

Study Start

November 13, 2014

Primary Completion

March 21, 2016

Study Completion

March 21, 2016

Last Updated

June 28, 2023

Results First Posted

September 16, 2019

Record last verified: 2019-08

Data Sharing

IPD Sharing
Will not share