Does Batten Grafting Improve Nasal Outcomes in Septoplasty and Turbinate Reduction?

Part of paid clinical trials in Poplar Bluff, Missouri.

Sponsor
Northwell Health
Study ID
NCT05287841
Status
Recruiting
Apply to this trial

Conditions

  • Allergic Rhinitis
  • Nasal Obstruction
  • Nasal Polyps
  • Nasal Valve Collapse
  • Septal Defect

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • Batten batten graft — PROCEDURE
    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 — PROCEDURE
    A portion of the quadrangular cartilage of the nasal septum is removed. This will be performed as a standard septoplasty.
  • Inferior Turbinate Reduction — PROCEDURE
    The bilateral inferior turbinates will be surgically ablated.

Study Details

The objective of this study is to compare the effectiveness of batten grafts plus septoplasty and turbinate reduction (intervention arm) compared to septoplasty and turbinate reduction alone (control arm), both in terms of subjective and objective assessments.

Key Dates

Start date
Apr 30, 2021
Status verified
Sep 2024
Primary completion
Dec 31, 2024
Completion
Jun 15, 2025

Study Design

Enrollment
96 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: 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.
  • Active Comparator: 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.

Primary Outcome Measure

Nasal Obstruction Symptom Evaluation (NOSE) score [ Time Frame: 12 months ]

Central Contacts

Locations (3)

FacilityCityStateZIPSite coordinators
Poplar Bluff Regional Medical CenterPoplar BluffMissouri63901
Alexandros Georgolios, MD, FACS
[email protected]
573-778-2600
McKenna Hawthorne
[email protected]
573-778-2600
Alexandros Georgolios, MD, FACS (PRINCIPAL_INVESTIGATOR)
Lenox Hill Hospital/Staten Island University HospitalNew YorkNew York10075
David Hiltzik, MD
[email protected]
718-226-6110
David Hiltzik, MD (PRINCIPAL_INVESTIGATOR)
Tristan Tham, MD (SUB_INVESTIGATOR)
Staten Island University HospitalStaten IslandNew York10305
David Hiltzik, MD
[email protected]
718-226-6110
Shannen Belotte, MBA
[email protected]
718-226-8559
David Hiltzik, MD (PRINCIPAL_INVESTIGATOR)
Tristan Tham (SUB_INVESTIGATOR)

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Poplar Bluff Regional Medical Center· Poplar Bluff, MOLenox Hill Hospital/Staten Island University Hospital· New York, NYStaten Island University Hospital· Staten Island, NY

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