Ignite Creation Date:
2025-12-24 @ 5:48 PM
Ignite Modification Date:
2025-12-29 @ 7:55 AM
Study NCT ID:
NCT04647968
Status:
RECRUITING
Last Update Posted:
2024-07-23
First Post:
2020-11-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Primary vs Secondary Closure of Tracheo-cutaneous Fistulas
Sponsor:
Université de Sherbrooke
Organization:
Study Overview
Official Title:
Primary vs Secondary Closure of Tracheo-cutaneous Fistulas: A Randomized Controlled Study
Status:
RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
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:
TRACH
Brief Summary:
The mean of this study is to compare primary and secondary closure of tracheo-cutaneous fistulas and evaluate the differences in outcomes between both techniques.
Detailed Description:
In this study the investigators wish to recruit patients with a tracheotomy that has been installed for various reasons and that is ready for closure. The investigators intend to randomly allocate them a mean of closure, either primary or secondary. Once the fistula is closed, the investigators will follow them over a substantial period of time to compare outcomes of each mean of closing. Different questionnaires will be used to best evaluate a range of variables.
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?: