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Assessment of Locked Nose Improvement in patients who received a Nasal Implant

Evaluation of the improvement rate of Nasal Obstruction by the NOSE Scale in patients submitted to Poly(e-caprolactone) Absorbable Nasal Implant (PCL)

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
REBEC
Registry ID
RBR-34tv3fz
Enrollment
Unknown
Registered
2021-12-06
Start date
2020-06-01
Completion date
Unknown
Last updated
2025-10-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Other specified disorders of the nose and paranasal sinuses

Interventions

Participants This study included 12 patients aged between 50 and 79 years, with insufficiency of the nasal lateral wall, who were randomly divided into two groups: the implanted group (n=6) and the c

Sponsors

Pontifícia Universidade Católica do Paraná
Lead Sponsor
Pontifícia Universidade Católica do Paraná
Collaborator

Eligibility

Age
50 Years to 79 Years

Inclusion criteria

Inclusion criteria: Patients aged between 50 and 79 years; with insufficiency of the nasal lateral wall confirmed through the positive Modified Cottle maneuver; with severe or extreme nasal obstruction in the evaluation by the NOSE Scale (Nasal Obstruction Symptom Evaluation Scale) (score = 55); impossibility or refusal to perform functional rhinoplasty; and lack of significant improvement after clinical treatment for at least four continuous months.

Exclusion criteria

Exclusion criteria: Smoking patients; with decompensated chronic rhinitis; with nasosinusal polyposis; with nasal granulomatous diseases; with any inflammatory or infectious diseases or conditions in the nasal or facial region; with a history of nasal implants or some type of nasal filling; with immunosuppressive disease; with healing disorders; with uncontrolled systemic diseases such as diabetes or heart disease.

Design outcomes

Primary

MeasureTime frame
Decrease in nasal obstruction symptoms measured by the NOSE (Nose Obstruction Symptom Evaluation) and EVA (Visual Analog Scale) scales after 6 months of placement of a bioabsorbable nasal implant.

Secondary

MeasureTime frame
Secondary outcomes are not expected.

Countries

Brazil

Contacts

Public ContactAnderson Merkle
aamerkle@yahoo.com+55 47 999712669

Outcome results

None listed

Source: REBEC (via WHO ICTRP)