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RECRUITING
NCT05287841
NA

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

Sponsor: Northwell Health

View on ClinicalTrials.gov

Summary

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.

Official title: Does the Addition of Batten Grafting Improve Nasal Outcomes in Patients Undergoing Septoplasty and Turbinate Reduction? A Pragmatic Randomized Controlled Trial

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

96

Start Date

2021-04-30

Completion Date

2025-06-15

Last Updated

2024-09-20

Healthy Volunteers

Yes

Interventions

PROCEDURE

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.

PROCEDURE

Septoplasty

A portion of the quadrangular cartilage of the nasal septum is removed. This will be performed as a standard septoplasty.

PROCEDURE

Inferior Turbinate Reduction

The bilateral inferior turbinates will be surgically ablated.

Locations (3)

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