Nasal Septum Perforation
Conditions
Keywords
nasoseptal flap, tissue repair, wound healing, remucosalization, upper airway, granulation tissue, tissue graft
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 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.
Interventions
OTHERBiodesign™ SIS graft
2x3 cm Biodesign™ SIS perforated mesentery graft
OTHERDoyle silastic sheet
Doyle silastic sheet
Sponsors
Stanford University
Cook Group Incorporated
University of Alabama at Birmingham
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean Change in Post-operative Remucosalization at the Donor Site | 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. |
| Mean Change in Post-operative Locoregional Crusting at Donor Site | 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. |
| Mean Change in Post-operative Edema at the Donor Site | 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. |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 21 |
| Control Group Thin Doyle silastic sheet placement alone over the resulting exposed septum cartilage/bone
Doyle silastic sheet: Doyle silastic sheet | 26 |
| Total | 47 |
Baseline characteristics
| Characteristic | Treatment Group | Control Group | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 5 Participants | 3 Participants | 8 Participants |
| Age, Categorical Between 18 and 65 years | 16 Participants | 23 Participants | 39 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 4 Participants | 7 Participants | 11 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 7 Participants | 10 Participants | 17 Participants |
| Race (NIH/OMB) White | 10 Participants | 8 Participants | 18 Participants |
| Sex: Female, Male Female | 15 Participants | 15 Participants | 30 Participants |
| Sex: Female, Male Male | 6 Participants | 11 Participants | 17 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 21 | 0 / 26 |
| other Total, other adverse events | 7 / 21 | 8 / 26 |
| serious Total, serious adverse events | 0 / 21 | 0 / 26 |
Outcome results
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.
Time frame: 2 weeks, 6 weeks, 12 weeks
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) |
|---|---|---|---|
| Treatment Group | Mean Change in Post-operative Edema at the Donor Site | 2 weeks | 3.34 score on a scale |
| Treatment Group | Mean Change in Post-operative Edema at the Donor Site | 6 weeks | 3.25 score on a scale |
| Treatment Group | Mean Change in Post-operative Edema at the Donor Site | 12 weeks | 2.26 score on a scale |
| Treatment Group | Mean Change in Post-operative Edema at the Donor Site | overall change | 2.95 score on a scale |
| Control Group | Mean Change in Post-operative Edema at the Donor Site | overall change | 3.11 score on a scale |
| Control Group | Mean Change in Post-operative Edema at the Donor Site | 2 weeks | 3.52 score on a scale |
| Control Group | Mean Change in Post-operative Edema at the Donor Site | 12 weeks | 2.65 score on a scale |
| Control Group | Mean Change in Post-operative Edema at the Donor Site | 6 weeks | 3.15 score on a scale |
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.
Time frame: 2 weeks, 6 weeks, 12 weeks
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) |
|---|---|---|---|
| Treatment Group | Mean Change in Post-operative Locoregional Crusting at Donor Site | 2 weeks | 3.50 score on a scale |
| Treatment Group | Mean Change in Post-operative Locoregional Crusting at Donor Site | 6 weeks | 4.22 score on a scale |
| Treatment Group | Mean Change in Post-operative Locoregional Crusting at Donor Site | 12 weeks | 2.64 score on a scale |
| Treatment Group | Mean Change in Post-operative Locoregional Crusting at Donor Site | overall change | 3.45 score on a scale |
| Control Group | Mean Change in Post-operative Locoregional Crusting at Donor Site | overall change | 4.11 score on a scale |
| Control Group | Mean Change in Post-operative Locoregional Crusting at Donor Site | 2 weeks | 4.22 score on a scale |
| Control Group | Mean Change in Post-operative Locoregional Crusting at Donor Site | 12 weeks | 2.92 score on a scale |
| Control Group | Mean Change in Post-operative Locoregional Crusting at Donor Site | 6 weeks | 5.2 score on a scale |
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.
Time frame: 2 weeks, 6 weeks, 12 weeks
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) |
|---|---|---|---|
| Treatment Group | Mean Change in Post-operative Remucosalization at the Donor Site | 2 weeks | 47.8 percentage of remucosalization |
| Treatment Group | Mean Change in Post-operative Remucosalization at the Donor Site | 6 weeks | 49.7 percentage of remucosalization |
| Treatment Group | Mean Change in Post-operative Remucosalization at the Donor Site | 12 weeks | 73.9 percentage of remucosalization |
| Treatment Group | Mean Change in Post-operative Remucosalization at the Donor Site | overall change | 57.1 percentage of remucosalization |
| Control Group | Mean Change in Post-operative Remucosalization at the Donor Site | overall change | 48.9 percentage of remucosalization |
| Control Group | Mean Change in Post-operative Remucosalization at the Donor Site | 2 weeks | 37.8 percentage of remucosalization |
| Control Group | Mean Change in Post-operative Remucosalization at the Donor Site | 12 weeks | 65.3 percentage of remucosalization |
| Control Group | Mean Change in Post-operative Remucosalization at the Donor Site | 6 weeks | 43.5 percentage of remucosalization |