Does Batten Grafting Improve Nasal Outcomes in Septoplasty and Turbinate Reduction?
NCT ID: NCT05287841
Last Updated: 2024-09-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
96 participants
INTERVENTIONAL
2021-04-30
2025-06-15
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Batten graft, plus septoplasty and inferior turbinate reduction
In the intervention arm, a portion of the quadrangular cartilage of the nasal septum is also removed, but will be refashioned and re-implanted into the patient as an autologous batten graft. This will be performed together with standard septoplasty and turbinate reduction.
Batten batten graft
The batten grafts are autologous grafts from the patients' own tissue, produced from nasal septal quadrangular cartilage. This will be obtained during the septoplasty portion of the procedure. The batten graft will be used to stabilize the internal nasal valve and prevent nasal valve collapse on inspiration.
Septoplasty
A portion of the quadrangular cartilage of the nasal septum is removed. This will be performed as a standard septoplasty.
Inferior Turbinate Reduction
The bilateral inferior turbinates will be surgically ablated.
Septoplasty and inferior turbinate reduction alone
In the control arm, a portion of the quadrangular cartilage of the nasal septum is removed. This will be performed as a standard septoplasty and turbinate reduction.
Septoplasty
A portion of the quadrangular cartilage of the nasal septum is removed. This will be performed as a standard septoplasty.
Inferior Turbinate Reduction
The bilateral inferior turbinates will be surgically ablated.
Interventions
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Batten batten graft
The batten grafts are autologous grafts from the patients' own tissue, produced from nasal septal quadrangular cartilage. This will be obtained during the septoplasty portion of the procedure. The batten graft will be used to stabilize the internal nasal valve and prevent nasal valve collapse on inspiration.
Septoplasty
A portion of the quadrangular cartilage of the nasal septum is removed. This will be performed as a standard septoplasty.
Inferior Turbinate Reduction
The bilateral inferior turbinates will be surgically ablated.
Eligibility Criteria
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Inclusion Criteria
1. Be age 18 or above
2. Able to provide written informed consent
3. Have an indication for batten graft, septoplasty and turbinate reduction according to prevailing surgical practices.
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1. Septal deviation must be present on direct or endoscopic examination
2. Inferior turbinate hypertrophy must be present, direct examination or endoscopic examination
3. Collapse of external nasal valve and/or lateral motion instability must be documented
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1. The ENV maye be assessed clinically by observing the alar collapse at baseline or with forced inspiration, Modified cottle may also be performed.
In all patients, endoscopic examination should document that the (a) septal deviation, (b) turbinate hypertrophy, and (c) external nasal valve collapse are the primary contributing factors of obstructed breathing.
Exclusion Criteria
2. History of previous functional rhinoplasty or sinus or septal surgery
3. Patients who are selected for concurrent aesthetic/cosmetic rhinoplasty
4. Untreated allergic rhinitis or allergic rhinitis unresponsive to medical management
5. Patients who have concurrent sinus surgery or polyp removal or concha bullosa resection
18 Years
ALL
Yes
Sponsors
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Northwell Health
OTHER
Responsible Party
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Principal Investigators
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David Hiltzik, MD
Role: PRINCIPAL_INVESTIGATOR
Northwell Health
Locations
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Poplar Bluff Regional Medical Center
Poplar Bluff, Missouri, United States
Lenox Hill Hospital/Staten Island University Hospital
New York, New York, United States
Staten Island University Hospital
Staten Island, New York, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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21-0204
Identifier Type: -
Identifier Source: org_study_id
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