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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Withdrawn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
Centre hospitalier de l'Université de Montréal (CHUM)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Head and Neck Neoplasms

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

    First Posted
    May 22, 2019
    Last Updated
    December 6, 2022
    Sponsor
    Centre hospitalier de l'Université de Montréal (CHUM)
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    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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