Nasal Septum PerforationNCT03159624
Nasal Septal Flap for Donor Site Reconstruction
A study testing Biodesign™ SIS graft and Doyle silastic sheet in people with Nasal Septum Perforation, run by University of Alabama at Birmingham.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Nasal Septum Perforation
- What is being tested?
- Biodesign™ SIS graft and Doyle silastic sheet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 47 participants
- Where
- No sites listed yet
- Study dates
- 13 Nov 2014to 21 Mar 2016
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
About this study
Official title: 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.
Read the 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.
- Conditions
- Nasal Septum Perforation
- Being tested
- Biodesign™ SIS graft, Doyle silastic sheet
- Keywords
- nasoseptal flap, tissue repair, wound healing, remucosalization, upper airway, granulation tissue, tissue graft
- Medical subject headings
- Nasal Septal Perforation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biodesign™ SIS graftOther
2x3 cm Biodesign™ SIS perforated mesentery graft
Doyle silastic sheetOther
Doyle silastic sheet
| Study group | Role | What they receive |
|---|---|---|
| Treatment Group | Experimental | 2x3 cm Biodesign™ SIS graft placement + overlying Doyle silastic sheet placement over the resulting exposed septum cartilage/bone Receives: Other: Biodesign™ SIS graft; Other: Doyle silastic sheet |
| Control Group | Active comparator | Thin Doyle silastic sheet placement alone over the resulting exposed septum cartilage/bone Receives: Other: Doyle silastic sheet |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 2 weeks, 6 weeks, 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2017
- Study start13 Nov 2014
- Primary completion21 Mar 2016
- Study completion21 Mar 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Nasal Septum PerforationStudies of the same condition, open and under way.
- More trials run by University of Alabama at BirminghamThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 47 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Collaborators
- Stanford University, Cook Group Incorporated
- Responsible party
- Principal investigator, Brad Woodworth, MD, University of Alabama at Birmingham
- Investigators
- Brad Woodworth, MD, Principal investigator, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03159624
- Sponsor's protocol ID
- F140612003
- Status last verified
- Aug 2019
- First submitted
- 17 May 2017
- Last updated
- 28 Jun 2023
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 29856526
Study at a glance
From the registry record, last updated by the sponsor on 28 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT03159624
- Acronym / sponsor ID
- F140612003
- Conditions
- Nasal Septum Perforation
- Keywords
- nasoseptal flap, tissue repair, wound healing, remucosalization, upper airway, granulation tissue, tissue graft
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 47 participants (actual)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Collaborators
- Stanford University, Cook Group Incorporated
- Study start
- 13 Nov 2014 (actual)
- Primary completion
- 21 Mar 2016 (actual)
- Study completion
- 21 Mar 2016 (actual)
- First posted
- 19 May 2017 (actual)
- Results
- Posted 16 Sep 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment Group | Experimental | Other: Biodesign™ SIS graft, Other: Doyle silastic sheet2x3 cm Biodesign™ SIS graft placement + overlying Doyle silastic sheet placement over the resulting exposed septum cartilage/bone |
| Control Group | Active comparator | Other: Doyle silastic sheetThin Doyle silastic sheet placement alone over the resulting exposed septum cartilage/bone |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Biodesign™ SIS graft2x3 cm Biodesign™ SIS perforated mesentery graft | Other | Treatment Group |
| Doyle silastic sheetDoyle silastic sheet | Other | Control Group, Treatment Group |
Primary outcome
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.
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.
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jun 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 29856526Nayak 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Brad Woodworth, MD principal investigator
University of Alabama at Birmingham
Questions about this trial
What is this clinical trial studying?
A study testing Biodesign™ SIS graft and Doyle silastic sheet in people with Nasal Septum Perforation, run by University of Alabama at Birmingham.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 16 Sep 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean Change in Post-operative Remucosalization at the Donor Site (time frame: 2 weeks, 6 weeks, 12 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03159624, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jun 2023; AzTrials last refreshed its copy on 2 Nov 2026.