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Batten Grafting for Nasal Obstruction

This study is looking at whether adding a "batten graft" to standard septoplasty and turbinate reduction surgery improves nasal breathing. A batten graft uses a small piece of your own nasal cartilage to support the side of your nose and prevent it from collapsing. Researchers want to compare patients who receive the batten graft along with septoplasty (surgery to fix a deviated septum) and turbinate reduction (surgery to shrink swollen tissues inside the nose) to those who only have septoplasty and turbinate reduction. The main goal is to see if the batten graft group has better symptom relief after 12 months, measured by a questionnaire called the Nasal Obstruction Symptom Evaluation (NOSE) score. The study is currently unclear on its recruitment status and plans to enroll 96 adults aged 18 or older who need these surgeries.

Study design
This interventional study aims to enroll 96 participants. It compares two surgical approaches for nasal obstruction.
What's involved
Participants will undergo either a septoplasty and turbinate reduction, or these procedures plus a batten graft. The batten graft is made from your own nasal cartilage during the septoplasty.
Compensation
Not stated in the trial record.
Follow-up
Participants' nasal obstruction symptoms will be evaluated 12 months after surgery.

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NCT05287841

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

Recruiting
NAAges 18+InterventionalTreatment
Northwell Health
~96 participants
Updated 2024-09-20 on ClinicalTrials.gov
What's tested:Batten batten graftSeptoplastyInferior Turbinate Reduction

At a glance

Recruiting sites
2 of 3 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Nasal Obstruction Symptom Evaluation (NOSE) score
Measured over 12 months

Conditions

Nasal Obstruction
Septal Defect
Allergic Rhinitis
Nasal Polyps
Nasal Valve Collapse

Explore related trials

Allergic RhinitisCardiac septal defectsNasal Cavity PolypNasal ObstructionNasal Valve Collapse

Where it's being run

3 sites across 2 states
New York2
Missouri1

Study leadership

  • David Hiltzik, MD · PRINCIPAL_INVESTIGATOR · Northwell Health

Who to contact

Research Department
[email protected]
718-226-6256
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Eligibility criteria

Inclusion

Patients should satisfy all the following criteria to be considered eligible for randomization:

What this trial measures

  • Nasal Obstruction Symptom Evaluation (NOSE) score12 months

    1. The NOSE scale is a scoring scale from 0 to 4 (0 = no problem for quality of life, 4 = a severe problem) under 5 different parameters 2. The sum of 5 different parameters are added up to give a range of possible sums from 0-20. This sum is then multiplied by 5 to give a final score with range 0-100. Ref: Stewart MG, Witsell DL, Smith TL, Weaver EM, Yueh B, Hannley MT. Development and validation of the nasal obstruction symptom evaluation (NOSE) scale. Otolaryngol Head Neck Surg 2004;130:157-163