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| Name | Class |
|---|---|
| Stanford University | OTHER |
| Cook Group Incorporated | INDUSTRY |
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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.
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:
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 patients will be assessed at 2 weeks, 6 weeks and 12 weeks following randomization and entry into this study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment Group | Experimental | 2x3 cm Biodesign™ SIS graft placement + overlying Doyle silastic sheet placement over the resulting exposed septum cartilage/bone |
|
| Control Group | Active Comparator | Thin Doyle silastic sheet placement alone over the resulting exposed septum cartilage/bone |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Biodesign™ SIS graft | Other | 2x3 cm Biodesign™ SIS perforated mesentery graft |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Brad Woodworth, MD | University of Alabama at Birmingham | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29856526 | Derived | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Treatment Group | 2x3 cm Biodesign™ SIS graft placement + overlying Doyle silastic sheet placement over the resulting exposed septum cartilage/bone Biodesign™ SIS graft: 2x3 cm Biodesign™ SIS perforated mesentery graft Doyle silastic sheet: Doyle silastic sheet |
| FG001 | Control Group | Thin Doyle silastic sheet placement alone over the resulting exposed septum cartilage/bone Doyle silastic sheet: Doyle silastic sheet |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Treatment Group | 2x3 cm Biodesign™ SIS graft placement + overlying Doyle silastic sheet placement over the resulting exposed septum cartilage/bone Biodesign™ SIS graft: 2x3 cm Biodesign™ SIS perforated mesentery graft Doyle silastic sheet: Doyle silastic sheet |
| BG001 | Control Group |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Least Squares Mean | 95% Confidence Interval | percentage of remucosalization | 2 weeks, 6 weeks, 12 weeks |
|
12 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Treatment Group | 2x3 cm Biodesign™ SIS graft placement + overlying Doyle silastic sheet placement over the resulting exposed septum cartilage/bone Biodesign™ SIS graft: 2x3 cm Biodesign™ SIS perforated mesentery graft Doyle silastic sheet: Doyle silastic sheet |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| minor septal perforation | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Brad Woodworth | University of Alabama at Birmingham | 205-801-7858 | bwoodworth@uabmc.edu |
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| ID | Term |
|---|---|
| D061270 | Nasal Septal Perforation |
| ID | Term |
|---|---|
| D009668 | Nose Diseases |
| D012140 | Respiratory Tract Diseases |
| D010038 | Otorhinolaryngologic Diseases |
| D014947 | Wounds and Injuries |
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| Doyle silastic sheet |
| Other |
Doyle silastic sheet |
|
Thin Doyle silastic sheet placement alone over the resulting exposed septum cartilage/bone Doyle silastic sheet: Doyle silastic sheet |
| BG002 | Total | Total of all reporting groups |
| Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Control Group |
Thin Doyle silastic sheet placement alone over the resulting exposed septum cartilage/bone Doyle silastic sheet: Doyle silastic sheet |
|
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| Primary | 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. | Posted | Least Squares Mean | 95% Confidence Interval | score on a scale | 2 weeks, 6 weeks, 12 weeks |
|
|
|
| Primary | 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. | Posted | Least Squares Mean | 95% Confidence Interval | score on a scale | 2 weeks, 6 weeks, 12 weeks |
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| 0 |
| 21 |
| 0 |
| 21 |
| 7 |
| 21 |
| EG001 | Control Group | Thin Doyle silastic sheet placement alone over the resulting exposed septum cartilage/bone Doyle silastic sheet: Doyle silastic sheet | 0 | 26 | 0 | 26 | 8 | 26 |
| development of transverse synechiae between septum and inferior turbinate | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
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| 12 weeks |
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| overall change |
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| 12 weeks |
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| overall change |
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