Reconstruction Flaps for Nasal Surgical Wounds

Overseen By Alejandra Onate, M.S.

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Northwestern University

Disqualifiers: Active infection, Age <18, Smoking, others

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

Compensation: Varies

Number of Visits: 1

Duration: 1 day

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines two methods for repairing wounds on the nasal tip: the nasalis sling flap and the lobed transposition flap. Researchers aim to determine which method provides better aesthetic and functional outcomes. The goal is to identify if one technique enhances appearance and breathing more effectively. Suitable candidates for this trial have nasal tip wounds no larger than 15mm, not caused by smoking or infections, and are willing to participate in the study. As an unphased trial, it offers participants the chance to contribute to innovative research that may enhance future treatment options.

Do I need to stop my current medications for the trial?

The trial information does not specify if you need to stop taking your current medications. However, if you are taking medication that severely impairs wound healing, you may not be eligible to participate.

What prior data suggests that these reconstruction flaps are safe for nasal surgical wounds?

Research shows that both the lobed transposition flap and the nasalis sling flap are generally safe for nose reconstruction.

For the lobed transposition flap, studies indicate it is well-tolerated. Surgeons have used it for many years with good results, and few serious issues have been reported. One study over 15 years found it to be a reliable and safe option.

For the nasalis sling flap, research shows it effectively repairs nose defects. This method uses skin and muscle to aid healing. Patients usually report good results after surgery, with studies noting improvements in appearance and function without major problems.

Both treatments have been studied extensively and have a strong safety record in nose reconstruction. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Nasalis Sling Flap and Lobed Transposition Flap because they offer innovative techniques for reconstructing nasal surgical wounds. Unlike traditional methods such as skin grafts and primary closure, these flaps provide more tailored tissue coverage and potentially better cosmetic outcomes. The Nasalis Sling Flap utilizes the nasalis muscle to create a more dynamic and natural-looking repair, while the Lobed Transposition Flap offers flexibility in covering complex wound shapes, which can improve healing and reduce scarring. These unique approaches could enhance patient satisfaction and recovery times compared to existing treatments.

What evidence suggests that this trial's treatments could be effective for nasal surgical wounds?

This trial will compare the effectiveness of two surgical methods for nasal reconstruction: the lobed transposition flap and the nasalis sling flap. Studies have shown that the lobed transposition flap effectively rebuilds the nose, providing stable and long-lasting results, particularly for nasal areas. Its two-part design aids wound healing. Research on the nasalis sling flap indicates that it uses the blood supply from an underlying muscle to repair nasal defects. This method can effectively correct certain nasal deformities, employing a technique called "V-Y advancement" to support the healing process. Both methods have been studied for their potential to improve outcomes in nasal reconstruction. ^{2 6 7 8 9}

Who Is on the Research Team?

Murad Alam, MD

Principal Investigator

Northwestern University

Are You a Good Fit for This Trial?

This trial is for adults over 18 with a nasal tip wound no larger than 15mm, who can understand and sign consent. It's not for those under 18, current smokers, people with infections or conditions that affect healing, or if their nose shape makes certain repairs less likely to work.

Inclusion Criteria

I am older than 18 years.

My nasal defect is on the tip or close to the tip of my nose.

My wound is 15mm long or shorter.

Exclusion Criteria

I currently have an infection.

I am under 18 years old.

My doctor thinks certain treatments won't work well for me due to my body's condition.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo nasal tip wound reconstruction surgery using either nasalis sling flaps or lobed flaps

1 day

1 visit (in-person)

Follow-up

Participants are monitored for functional and aesthetic outcomes using various questionnaires

6-16 weeks

Multiple visits (in-person and virtual)

What Are the Treatments Tested in This Trial?

Interventions

• Lobed Transposition Flap
• Nasalis Sling Flap

Trial Overview The study compares two types of nasal reconstruction techniques: nasalis sling flaps versus lobed transposition flaps. Participants will be randomly assigned to one of the methods and will complete questionnaires to assess aesthetic and functional outcomes.

How Is the Trial Designed?

Group I: Nasalis Sling Flap Active Control 1 Intervention

Group II: Lobed transposition flap Active Control 1 Intervention

Who Is Running the Clinical Trial?

Northwestern University

Lead Sponsor

Trials

1,674

Recruited

989,000+

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39212386/

A Comprehensive Review of Bilobed Flaps in Nasal ... This retrospective review examines a single surgeon's experience with bilobed flaps for nasal reconstruction over the last 15 years.

2. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0294126024000542

Reconstruction of caudal nose defects with bilobe flap Conclusion. Overall, the bilobe flap technique proved to be an effective and reliable option for nasal reconstruction, providing stable and long-lasting results ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12117574/

Defect Size Dependent Reconstruction Strategy of the Nasal ... The bilobed flap demonstrates enhanced biomechanical efficacy through its dual-lobed configuration, achieving simultaneous optimization of wound ...

4. mdpi.com mdpi.com/1648-9144/56/12/639

Nose Reconstruction: Nasal Cutaneous Defects Management A nasolabial transposition flap is a viable option for alar reconstruction; anyway, this single-stage option results in a deformation of the alar facial sulcus ...

5. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/10.1111/ijd.17155

Nasal Tip Rotation Flap for Distal Nose Reconstruction The nasal tip rotation flap is a reliable reconstruction option for MMS defects of the distal nose. This flap can be used for defects that involve the nasal ...

6. ncbi.nlm.nih.gov ncbi.nlm.nih.gov/books/NBK500028/

Transposition Flaps - StatPearls - NCBI Bookshelf Transposition flaps involve incising noncontiguous donor tissue and rotating it around adjacent intact tissue to close a defect.

7. journals.lww.com journals.lww.com/dermatologicsurgery/Abstract/9000/Use_of_Extranasal_Bilobed_Transposition_Flaps_in.97998.aspx

Use of Extranasal Bilobed Transposition Flaps in ... Bilobed transposition flaps are versatile repairs for extranasal reconstruction with a favorable safety and outcome profile. In cutaneous reconstruction ...

8. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/10.1111/jocd.16032

Repair of Asian nasal subunit defects using nasolabial ... This retrospective study evaluated 58 Chinese patients who underwent nasal reconstruction with the nasolabial perforator flap from 2009 to 2021.

9. theajo.com theajo.com/article/view/4421/html

Forehead flap nasal reconstruction: oncologic and ... There were no cases of complete flap failure with only one case of partial flap necrosis. Conclusions: Outcomes are comparable to those achieved at tertiary ...