Batten Grafting for Nasal Valve Collapse

Recruiting in Palo Alto (17 mi)

+3 other locations

Overseen by David Hiltzik, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Northwell Health

Disqualifiers: Septal perforation, Previous rhinoplasty, others

No Placebo Group

Trial Summary

What is the purpose of this trial?

This trial compares adding supportive pieces to standard nasal surgery with just the standard surgery alone. It targets patients with blocked noses due to a crooked septum. The added support helps keep the nose open and improves airflow.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the treatment Batten Grafting for Nasal Valve Collapse?

Research shows that various techniques for reducing the size of the inferior turbinates, such as submucosal resection and radiofrequency ablation, effectively improve nasal breathing by reducing nasal obstruction. These methods have been shown to improve symptoms significantly, as indicated by reduced Nasal Obstruction Symptom Evaluation (NOSE) scores, and have low complication rates. ^{1 2 3 4 5}

Is Batten Grafting for Nasal Valve Collapse generally safe in humans?

Research on similar procedures like inferior turbinate reduction shows they are generally safe, with no significant complications reported in studies, especially in children. Techniques like microdebrider and coblation have been evaluated for safety and found to have minimal adverse side effects. ^{1 6 7 8 9}

How does the Batten Grafting for Nasal Valve Collapse treatment differ from other treatments for nasal valve collapse?

This treatment is unique because it combines batten grafting, which supports the nasal structure, with inferior turbinate reduction and septoplasty to address both structural and airflow issues, potentially offering a more comprehensive solution for nasal valve collapse compared to treatments that focus solely on one aspect. ^{1 3 5 10 11}

Research Team

David Hiltzik, MD

Principal Investigator

Northwell Health

Eligibility Criteria

This trial is for adults over 18 with breathing obstruction due to a deviated septum, enlarged turbinates, and external nasal valve collapse. Candidates must be able to consent and have these conditions confirmed by clinical examination. It's not for those with septal perforation, untreated/unresponsive allergic rhinitis, past nose surgeries, or concurrent sinus/polyp surgery.

Inclusion Criteria

I have been diagnosed with swollen nasal passages.

Your nose may be checked by looking for a collapse when you breathe in or by performing a Modified Cottle test.

I need surgery to correct my nasal passage according to standard practices.

Exclusion Criteria

I am chosen for a nose job at the same time as my other procedure.

I have a hole in the wall dividing my nostrils.

I have untreated or treatment-resistant allergic rhinitis.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo septoplasty and turbinate reduction, with or without batten grafting

1 day (surgical procedure)

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessments of nasal obstruction and other outcomes

12 months

Multiple visits (in-person and virtual)

Treatment Details

Interventions

• Batten Graft (Procedure)
• Inferior Turbinate Reduction (Procedure)
• Septoplasty (Procedure)

Trial Overview The study tests if adding batten grafts to standard septoplasty and turbinate reduction improves nasal airflow more effectively than the standard procedure alone. Participants will be divided into two groups: one receiving the combined treatment (intervention arm) and one receiving only the standard treatment (control arm).

Participant Groups

Group I: Batten graft, plus septoplasty and inferior turbinate reduction Experimental Treatment 3 Interventions

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.

Group II: Septoplasty and inferior turbinate reduction alone Active Control 2 Interventions

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.

Inferior Turbinate Reduction is already approved in Canada, Japan for the following indications:

Approved in Canada as Submucous Resection for:

• Nasal obstruction
• Chronic nasal congestion
• Enlarged inferior turbinates

Approved in Japan as Radiofrequency Inferior Turbinate Reduction for:

• Nasal obstruction
• Chronic rhinitis
• Allergic rhinitis

Who Is Running the Clinical Trial?

Northwell Health

Lead Sponsor

Trials

481

Recruited

470,000+

Michael Dowling

Northwell Health

Chief Executive Officer since 2002

Bachelor's and Master's degrees from University College Cork, Ireland

Dr. David Battinelli

Northwell Health

Chief Medical Officer since 2022

MD from Georgetown University School of Medicine

Findings from Research

Chronic nasal obstruction, often caused by inferior turbinate enlargement due to hypersensitive rhinitis, can lead to sleep disorders and reduced quality of life, but many cases respond well to topical corticosteroids.

For cases where long-standing swelling becomes irreversible, surgical techniques like radiofrequency ablation and microdebrider methods effectively reduce inferior turbinate size with fewer adverse side effects compared to traditional approaches.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Surgical techniques of the inferior nasal turbinates in the treatment of nasal obstruction]. Lilja, M., Virkkula, P.[2015]

A novel surgical technique for inferior turbinectomy significantly improved nasal obstruction symptoms, with preoperative NOSE scores averaging 67.8 and postoperative scores dropping to 16.1, indicating effective volume reduction.

Postoperative outcomes showed no bleeding and only minor crusting in 13 out of 18 patients, suggesting enhanced safety and reduced complications compared to traditional methods.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

How I Do It: Inferior Turbinectomy: Modified Techniques for Submucosal Resection. Omura, K., Nomura, K., Takeda, T., et al.[2021]

Inferior turbinate reduction is an effective surgical technique for improving nasal breathing in patients with turbinate hypertrophy, with most patients experiencing subjective improvement, although this effectiveness may decrease over time.

The procedure generally has low complication rates, but there is a rare risk of developing empty nose syndrome, particularly with more extensive reductions, highlighting the importance of techniques that preserve turbinate mucosa for maintaining normal nasal function.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Surgical Management of Turbinate Hypertrophy. Bergmark, RW., Gray, ST.[2018]

The described surgical technique for inferior turbinectomy, used since February 2002, effectively reduces the size of the inferior turbinates while preserving mucosal continuity, which may enhance recovery.

By covering the raw surface with a mucosal flap, this method aims to minimize common post-operative complications such as dryness, infection, bleeding, and pain, suggesting a safer approach to improving nasal airflow.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Endoscopic, assisted, modified turbinoplasty with mucosal flap. Puterman, MM., Segal, N., Joshua, BZ.[2013]

A new technique for reducing the size of inferior turbinates using a microdebrider was assessed in a study of 120 patients, showing it to be a safe method with a low complication rate of only 1.6% for postoperative bleeding.

This microdebrider technique allows for precise control over tissue removal, resulting in minimal morbidity and avoiding common complications like excessive resection and crusting, which are often seen with traditional methods.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A safe, alternative technique for inferior turbinate reduction. Friedman, M., Tanyeri, H., Lim, J., et al.[2022]

Surgery on the inferior turbinates should only be considered after trying medical therapy, emphasizing the importance of conservative treatment first.

Various surgical methods, such as cauterization and laser vaporization, can reduce turbinate size, but the least invasive option that still ensures good airflow should be prioritized.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Surgery of the inferior turbinates: how much and when? Mabry, RL.[2017]

Microdebrider-assisted inferior turbinoplasty (MAIT) and submucosal resection (SR) both effectively relieve nasal obstruction in children with hypertrophic inferior turbinates, as shown in a study of 120 children.

MAIT is superior to SR in preserving nasal mucosa, with no observed nasal crusting post-surgery, while SR resulted in increased nasal secretions and crusting shortly after the procedure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of microdebrider-assisted inferior turbinoplasty and submucosal resection for children with hypertrophic inferior turbinates. Chen, YL., Liu, CM., Huang, HM.[2018]

In a study of 70 patients with enlarged inferior turbinates, both coblation and microdebrider techniques significantly improved nasal symptoms, but coblation resulted in less postoperative pain.

Coblation was found to be as effective as microdebrider for reducing turbinate size, with fewer instances of postoperative bleeding and mucosal tears, leading to high patient satisfaction after both procedures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Inferior turbinate reduction; coblation versus microdebrider - a prospective, randomised study. Hegazy, HM., ElBadawey, MR., Behery, A.[2022]

In a study of 22 children aged 15 years and below, 68% reported sustained improvement in their nasal airway after surgical reduction of the inferior turbinate, indicating its effectiveness.

The procedure was found to be safe, with no significant post-operative complications such as serious bleeding or excessive dryness, suggesting it is a reliable treatment for severe nasal obstruction in children.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Surgical reduction of the inferior turbinate in children: extended follow-up. Thompson, AC.[2019]

Submucous resection of the turbinate bone in 70 patients with chronic hypertrophic lower turbinates resulted in over 70% of patients reporting significant improvement in nasal breathing after the procedure.

The surgery was performed with minimal bleeding and no serious complications, highlighting its safety and effectiveness in preserving mucosal function.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Submucous turbinate resection]. Schmoldt, U., Hildmann, H., Servatius, K.[2006]

In a study of 80 patients undergoing alar batten grafting for nasal valve collapse, there was a significant increase in the size of the nasal valve aperture, leading to improved breathing and cosmetic appearance for all patients.

The procedure showed no major complications, indicating that alar batten grafting is a safe and effective long-term solution for correcting both internal and external nasal valve collapse.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Alar batten cartilage graft: treatment of internal and external nasal valve collapse. Cervelli, V., Spallone, D., Bottini, JD., et al.[2022]

References

1. Finland pubmed.ncbi.nlm.nih.gov

[Surgical techniques of the inferior nasal turbinates in the treatment of nasal obstruction]. [2015]

2. United States pubmed.ncbi.nlm.nih.gov

How I Do It: Inferior Turbinectomy: Modified Techniques for Submucosal Resection. [2021]

3. United States pubmed.ncbi.nlm.nih.gov

Surgical Management of Turbinate Hypertrophy. [2018]

4. England pubmed.ncbi.nlm.nih.gov

Endoscopic, assisted, modified turbinoplasty with mucosal flap. [2013]

5. United States pubmed.ncbi.nlm.nih.gov

A safe, alternative technique for inferior turbinate reduction. [2022]

6. England pubmed.ncbi.nlm.nih.gov

Surgery of the inferior turbinates: how much and when? [2017]

7. Ireland pubmed.ncbi.nlm.nih.gov

Comparison of microdebrider-assisted inferior turbinoplasty and submucosal resection for children with hypertrophic inferior turbinates. [2018]

8. Netherlands pubmed.ncbi.nlm.nih.gov

Inferior turbinate reduction; coblation versus microdebrider - a prospective, randomised study. [2022]

9. England pubmed.ncbi.nlm.nih.gov

Surgical reduction of the inferior turbinate in children: extended follow-up. [2019]

10. Germany pubmed.ncbi.nlm.nih.gov

[Submucous turbinate resection]. [2006]

11. United States pubmed.ncbi.nlm.nih.gov

Alar batten cartilage graft: treatment of internal and external nasal valve collapse. [2022]