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The Role of Spreader Grafts in Reduction Rhinoseptoplasty: a Randomized Clinical Trial With Quality of Life Assessment

H

Hospital de Clinicas de Porto Alegre

Status

Unknown

Conditions

Nasal Obstruction
Rhinoplasty

Treatments

Procedure: Spreader Graft

Study type

Interventional

Funder types

Other

Identifiers

NCT04499469
91672218400005327

Details and patient eligibility

About

Nasal obstruction is one of the majors concerns in reduction rhinoseptoplasty, because it affects quality of life and surgical outcomes. Is the association of middle third grafts with reduction rhinoseptoplasty responsible for an increase in quality of life related to nasal obstruction when compared to reduction rhinoseptoplasty without the placement of these grafts?

Full description

Reduction rhinoplasty and rhinoseptoplasty are among the most accomplished aesthetic procedures in Plastic Surgery and Otorhinolaryngology. Nasal obstruction is one of the majors concerns in this procedures, because it affects quality of life and surgical outcomes. Nasal surgeons have paid much attention to nasal valve area to prevent nasal obstruction and some assert reconstruction of the middle vault after dorsal reduction with grafts. The gold standard for middle vault reconstruction after dorsal reduction has been the spreader graft, first advocated by Sheen. Studies in surgical techniques for the treatment of nasal valve collapse focus much more in techniques than in evidence of its efficacy.

Enrollment

50 estimated patients

Sex

All

Ages

14 to 80 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • Patients eligible for reduction rhinoseptoplasty who agreed to participate in the study and who did not meet the exclusion criteria

Exclusion criteria

  • Absence of nasal obstruction;
  • Previous nasosinusal surgery;
  • Symmetrical or asymmetric insufficiency of the middle third that would justify the placement of middle third grafts for the treatment of these problems;
  • Presence of nasal valve insufficiency as the only cause of nasal obstruction;
  • Cranio-facial anomalies;
  • Presence of nasosinusal tumors;
  • Active acute rhinosinusitis;
  • Patients undergoing treatment of other entities concomitant to rhinoseptoplasty such as: sinus inflammatory surgery, adenoid hypertrophy removal, septal perforation correction, otoplasty or blepharoplasty.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

50 participants in 2 patient groups

Spreader Graft
Experimental group
Description:
Placement and attachment with 5.0 polydioxanone (PDS) suture 2 grafts in the middle third of the nose
Treatment:
Procedure: Spreader Graft
Without Spreader Graft
No Intervention group
Description:
No engraftment in the middle third

Trial contacts and locations

1

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Central trial contact

Michelle Lavinsky-Wolff, PhD; Raphaella Migliavacca, MsC

Data sourced from clinicaltrials.gov

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