Ignite Creation Date:
2025-12-24 @ 10:51 PM
Ignite Modification Date:
2025-12-24 @ 10:51 PM
Study NCT ID:
NCT04499469
Status:
UNKNOWN
Last Update Posted:
2020-08-05
First Post:
2020-07-21
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Role of Spreader Grafts in Reduction Rhinoseptoplasty: a Randomized Clinical Trial With Quality of Life Assessment
Sponsor:
Hospital de Clinicas de Porto Alegre
Organization:
Study Overview
Official Title:
The Role of Spreader Grafts in Reduction Rhinoseptoplasty: a Randomized Clinical Trial With Quality of Life Assessment
Status:
UNKNOWN
Status Verified Date:
2020-07
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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?
Detailed 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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: