Batten Grafting for Nasal Valve Collapse

Recruiting at 3 trial locations

Overseen By Research Department

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Northwell Health

Disqualifiers: Septal perforation, Previous rhinoplasty, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

Duration: 1 day (surgical procedure)

96 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if adding a batten graft (a surgical implant) to septoplasty and turbinate reduction surgeries improves breathing. These procedures address breathing issues caused by a crooked septum or enlarged turbinates in the nose. The trial compares two groups: one receiving the graft along with the usual procedures, and the other undergoing only the usual procedures. Candidates for the trial experience breathing difficulties due to a collapsed nasal valve or similar issues. As an unphased trial, this study provides an opportunity to explore innovative surgical solutions for breathing difficulties.

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 prior data suggests that batten grafting is safe for nasal valve collapse?

Research has shown that batten grafts are generally safe for treating nasal valve collapse. These small pieces of cartilage support the nose and improve breathing by keeping the nasal passage open. Studies report that patients tolerate this procedure well, with few side effects.

Additionally, research on septoplasty and turbinate reduction, often performed alongside batten grafts, indicates these procedures are also safe. Patients typically experience mild, temporary side effects like swelling or discomfort, which are common after surgery and resolve over time.

Overall, the use of batten grafts, along with septoplasty and turbinate reduction, has a strong safety record. However, as with any medical treatment, discussing potential risks with a healthcare provider is important. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about batten grafting for nasal valve collapse because it introduces an innovative approach by using an autologous batten graft. Unlike the standard treatments that typically involve septoplasty and inferior turbinate reduction, this method refashions and re-implants a portion of the patient’s own nasal cartilage. This technique could potentially offer enhanced structural support and improved airflow, addressing nasal valve collapse more effectively. By utilizing tissue from the patient's own body, it reduces the risk of rejection and complications associated with synthetic materials.

What evidence suggests that batten grafting is effective for nasal valve collapse?

Research has shown that batten grafts effectively treat nasal valve collapse. Studies have found that these grafts can greatly improve nasal breathing by supporting the nasal valve, a common issue for individuals with this condition. In this trial, one group of participants will receive a batten graft along with septoplasty and inferior turbinate reduction. One study revealed that patients who had their septal deviation corrected with batten grafts experienced a drop in their Nose Scale score from 75.5% to 17.3%, indicating significant improvement. Other research indicates that batten grafts can straighten the septum in 90% of cases. Overall, batten grafts enhance both the appearance and breathing function of the nose. ^{1 2 6 7 8}

Who Is on the Research Team?

David Hiltzik, MD

Principal Investigator

Northwell Health

Are You a Good Fit for This Trial?

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.

Timeline for a Trial Participant

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)

What Are the Treatments Tested in This Trial?

Interventions

• Batten Graft
• Inferior Turbinate Reduction
• Septoplasty

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).

How Is the Trial Designed?

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 United States, European Union, Canada, Japan for the following indications:

Approved in United States as Turbinate Reduction Surgery for:

• Nasal obstruction
• Chronic nasal congestion
• Enlarged inferior turbinates

Approved in European Union as Inferior Turbinate Resection for:

• Nasal obstruction
• Chronic rhinitis
• Allergic rhinitis

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+

Published Research Related to This Trial

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]

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]

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]

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]

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]

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]

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]

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]

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]

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]

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]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05287841

NCT05287841 | Does Batten Grafting Improve Nasal ... 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 ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3638702/

Internal Nasal Valve Incompetence Is Effectively Treated ... Conclusions. Alar batten graft insertion as a single technique is a valid technique in treating INVI and produces good outcomes. 1. Introduction. Internal ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S1808869425000163

Effectiveness of bony batten grafting for correction ... Results. There was a reduction in the Nose Scale from 75.5% to 17.3% in patients who underwent septal deviation correction using this graft (p < 0.001) ...

4. aao-hnsfjournals.onlinelibrary.wiley.com aao-hnsfjournals.onlinelibrary.wiley.com/doi/full/10.1002/ohn.70010

Alar Battens Grafts Versus Lateral Crural Strut Grafts There are several options for the surgical management of nasal valve collapse that have demonstrated excellent cosmetic and functional results.

5. jamanetwork.com jamanetwork.com/journals/jamaotolaryngology/fullarticle/1157686

Septal Batten Graft to Correct Cartilaginous Deformities in ... The batten graft was performed with either septal cartilage (n = 21) or bony septum (n = 9). A straight septum was achieved in 90% of all procedures. Subjective ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11983596/

Nasal valve obstruction: a comprehensive analysis of the ... This review explores the persisting controversies of NVO management, emphasising the lack of consensus in diagnostic criteria and treatment protocols.

7. liebertpub.com liebertpub.com/abs/doi/10.1001/jamafacial.2013.974

The Effects of Alar Batten Grafts on Nasal Airway ... The use of alar batten grafts may improve NAO in patients with nasal allergic symptoms and reduces their use of nasal steroids.

8. michelepascali.it michelepascali.it/wp-content/uploads/2018/02/alar-batten.pdf

Alar Batten Cartilage Graft: Treatment of Internal and ... Conclusion The alar batten graft is a simple, versatile technique for long-term reshaping, repositioning, and reconstruction of the nasal valve collapse.