Ignite Creation Date:
2025-12-25 @ 2:15 AM
Ignite Modification Date:
2026-03-03 @ 3:00 PM
Study NCT ID:
NCT03971760
Status:
WITHDRAWN
Last Update Posted:
2022-12-08
First Post:
2019-05-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Ideal Drainage Output of Post-operative Neck Suction Drain
Sponsor:
Centre hospitalier de l'Université de Montréal (CHUM)
Organization:
Study Overview
Official Title:
Ideal Drainage Output of Post-operative Neck Suction Drain: a Randomized Controlled Trial
Status:
WITHDRAWN
Status Verified Date:
2022-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
COVID pandemic
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
A precautionary measure that is frequently used after a neck surgery is the usage of suction drains, which allow the evacuation or air and fluids accumulated at the site of the surgery using negative pressure. Theoretically this helps promote better healing of the wound. Usage of suction drains, however, requires keeping some patients hospitalized after surgery for drain surveillance while they could have otherwise been discharged to safely begin their convalescence at home. In other cases, patient hospitalisation can be prolonged by the usage of suction drains, because surgeons wait for the output of the drain to fall below a certain quantity before removing them. This of course results in additional costs to the health system. The quantity below which the drain output should fall before drain removal is however not something agreed upon in the medical literature and is generally based on a surgeon's personal experience or that of the institution in which they practice. It would be important to better define this value, since prolonged usage of suction drains is not risk-free. Indeed, they constitute, among other things, an access for bacteria to cause an infection to develop inside the neck, which compromises wound healing and may result in more pronounced scarring. This study aims to compare a frequently used output value (30 mL per 24 hours) with a more permissive one of 50 mL per 24 hours. The investigators will look more specifically at wound complications, length of hospitalisation and cost-effectiveness for the health system. This study will recruit patients undergoing neck surgery at the Centre Hospitalier de l'Université de Montréal to compare both of these suction drain output values.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
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?: