Sponsor study identifier
interventional
47
0 countries
N/A
Study Start
November 13, 2014
Actual (reported)Primary Completion
March 21, 2016
Actual (reported)Study Completion
March 21, 2016
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
March 21, 2016
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
November 13, 2014
Actual (reported)March 21, 2016
Actual (reported)March 21, 2016
Actual (reported)May 17, 2017
Actual (reported)May 19, 2017
Actual (reported)September 16, 2019
Actual (reported)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.
2x3 cm Biodesign™ SIS graft placement + overlying Doyle silastic sheet placement over the resulting exposed septum cartilage/bone
Thin Doyle silastic sheet placement alone over the resulting exposed septum cartilage/bone
2x3 cm Biodesign™ SIS perforated mesentery graft
Doyle silastic sheet
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.
Brad Woodworth, MD
University of Alabama at Birmingham
47 participants (actual enrollment reported by the registry).
First Submitted
May 17, 2017
First Posted
May 19, 2017
Study Start
November 13, 2014
Actual (reported)2 weeks, 6 weeks, 12 weeks
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
Primary Completion
March 21, 2016
Actual (reported)Study Completion
March 21, 2016
Actual (reported)Last Updated
June 28, 2023
Results First Posted
September 16, 2019
Record last verified: 2019-08
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.
Source retrieved: