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Search / Trial NCT05287841

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

Launched by NORTHWELL HEALTH · Mar 11, 2022

Trial Information

Current as of June 26, 2025

Recruiting

Keywords

ClinConnect Summary

This clinical trial is studying whether adding a batten graft to standard nasal surgeries, like septoplasty and turbinate reduction, can help improve breathing more effectively than just the standard surgeries alone. Septoplasty corrects a crooked septum (the wall between the nostrils), and turbinate reduction helps with swollen structures in the nose that can block airflow. The goal is to see if the batten graft can provide better results for patients suffering from nasal obstruction, which can be caused by issues like a deviated septum, enlarged turbinates, or nasal valve collapse.

To participate in this study, individuals must be 18 years or older and able to give informed consent. They should have specific problems affecting their breathing, such as a deviated septum and enlarged turbinates. However, people with certain conditions, like a hole in the septum or previous nasal surgeries, cannot join. Participants will have the opportunity to receive either the batten graft along with the other procedures or just the standard surgeries. Throughout the trial, researchers will closely monitor their progress to determine the effectiveness of the batten graft in improving nasal breathing.

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • * Patients should satisfy all the following criteria to be considered eligible for randomization:
  • 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:
  • 1. Septal perforation
  • 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

About Northwell Health

Northwell Health is a leading integrated health system based in New York, dedicated to advancing healthcare through innovative research and clinical trials. With a commitment to improving patient outcomes and enhancing medical knowledge, Northwell Health conducts a diverse range of clinical studies across various therapeutic areas. The organization harnesses its extensive network of hospitals, outpatient facilities, and research institutes to facilitate cutting-edge research, ensuring access to advanced treatments for patients while fostering collaboration among healthcare professionals, researchers, and industry partners. By prioritizing patient-centric approaches and leveraging state-of-the-art technology, Northwell Health aims to drive significant advancements in medical science and public health.

Locations

Staten Island, New York, United States

New York, New York, United States

Poplar Bluff, Missouri, United States

New York, New York, United States

Patients applied

0 patients applied

Trial Officials

David Hiltzik, MD

Principal Investigator

Northwell Health

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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