Ideal Drainage Output of Post-operative Neck Suction Drain
Primary Purpose
Head and Neck Neoplasms, Drain Site Complication, Neck Dissection
Status
Withdrawn
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Suction drain removal
Sponsored by
About this trial
This is an interventional treatment trial for Head and Neck Neoplasms
Eligibility Criteria
Inclusion Criteria:
- 18 years and older of age
- Patient having undergone neck surgery at the CHUM
- Patient operated by an Ear Nose and Throat - Head and Neck surgeon at the CHUM
- Patient with at least one suction drain left post-operatively
Exclusion Criteria:
- Non-suction drain (e.g. capillarity)
- Free-flap reconstruction cases
- Patient with past surgical history of neck dissection
- Patient with pas medical history of radiation therapy in the head and neck
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Group 1: 30cc/24h
Group 2: 50cc/24h
Arm Description
This group represents the currently used value of drain output used to determine the timing of drain removal
This group represents the experimental value of drain output used to determine the timing of drain removal
Outcomes
Primary Outcome Measures
Duration of drainage
The length of time during which the suction drain is left in place, from the time of the surgery to the time of drain removal
Secondary Outcome Measures
Seroma rate
The rate of seroma as wound complication, defined as an accumulation of serous fluid in the surgical space
Full Information
NCT ID
NCT03971760
First Posted
May 22, 2019
Last Updated
December 6, 2022
Sponsor
Centre hospitalier de l'Université de Montréal (CHUM)
1. Study Identification
Unique Protocol Identification Number
NCT03971760
Brief Title
Ideal Drainage Output of Post-operative Neck Suction Drain
Official Title
Ideal Drainage Output of Post-operative Neck Suction Drain: a Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
December 2022
Overall Recruitment Status
Withdrawn
Why Stopped
COVID pandemic
Study Start Date
November 2021 (Anticipated)
Primary Completion Date
March 2022 (Anticipated)
Study Completion Date
June 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre hospitalier de l'Université de Montréal (CHUM)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Head and Neck Neoplasms, Drain Site Complication, Neck Dissection
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Group 1: 30cc/24h
Arm Type
Active Comparator
Arm Description
This group represents the currently used value of drain output used to determine the timing of drain removal
Arm Title
Group 2: 50cc/24h
Arm Type
Experimental
Arm Description
This group represents the experimental value of drain output used to determine the timing of drain removal
Intervention Type
Other
Intervention Name(s)
Suction drain removal
Intervention Description
Removal of negative pressure suction drain left in place to drain the surgical space after a neck surgery
Primary Outcome Measure Information:
Title
Duration of drainage
Description
The length of time during which the suction drain is left in place, from the time of the surgery to the time of drain removal
Time Frame
At the time of patient discharge from the ward, usually up to 1 week
Secondary Outcome Measure Information:
Title
Seroma rate
Description
The rate of seroma as wound complication, defined as an accumulation of serous fluid in the surgical space
Time Frame
Up to 6 weeks following surgery
Other Pre-specified Outcome Measures:
Title
Duration of admission
Description
Length of patient's stay in hospital after surgery
Time Frame
At the time of patient discharge from the ward, usually up to 1 week
Title
Wound infection
Description
Surgical site infection following surgery
Time Frame
Up to 6 weeks following surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
18 years and older of age
Patient having undergone neck surgery at the CHUM
Patient operated by an Ear Nose and Throat - Head and Neck surgeon at the CHUM
Patient with at least one suction drain left post-operatively
Exclusion Criteria:
Non-suction drain (e.g. capillarity)
Free-flap reconstruction cases
Patient with past surgical history of neck dissection
Patient with pas medical history of radiation therapy in the head and neck
12. IPD Sharing Statement
Learn more about this trial
Ideal Drainage Output of Post-operative Neck Suction Drain
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