NCT05287841

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

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 96 (estimated)
• Sponsor: Northwell Health · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Detailed description

One of the most common reasons to pursue nasal surgery is for nasal obstruction caused by a septal deviation. Otolaryngologists frequently perform septoplasties to improve nasal obstruction due to septal deviation, leading to improved airflow and decrease office visits and medication use. Concurrently with septal deviations, the inferior turbinate tends to become hypertrophied on the contralateral side potentially causing additional nasal obstruction. While septal deviations and inferior turbinate hypertrophy are more anatomical causes of nasal obstruction, there are also other types that vary depending on nasal airflow, such as nasal valve collapse. One way to surgically correct such dynamic nasal obstruction includes alar batten grafts. These grafts are not meant to change the anatomy of the nose, but instead, function to support the weakened lateral wall. Expanding the current septoplasty procedure to include batten grafts as well as inferior turbinate reduction could possibly improve long-term outcomes, especially reducing future surgeries.

Conditions

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

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2021-04-30
• Primary completion: 2024-12-31
• Completion: 2025-06-15
• First posted: 2022-03-18
• Last updated: 2024-09-20

Locations

3 sites across 1 country: United States