Head and Neck NeoplasmsNCT03971760
Ideal Drainage Output of Post-operative Neck Suction Drain
A study testing Suction drain removal in people with Head and Neck Neoplasms and Drain Site Complication, run by Centre hospitalier de l'Université de Montréal (CHUM).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Head and Neck Neoplasms, Drain Site Complication, Neck Dissection
- What is being tested?
- Suction drain removal
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Nov 2021to Jun 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
About this study
Official title: Ideal Drainage Output of Post-operative Neck Suction Drain: a Randomized Controlled Trial
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.
- Being tested
- Suction drain removal
- Medical subject headings
- Head and Neck Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Suction drain removalOther
Removal of negative pressure suction drain left in place to drain the surgical space after a neck surgery
| Study group | Role | What they receive |
|---|---|---|
| Group 1: 30cc/24h | Active comparator | This group represents the currently used value of drain output used to determine the timing of drain removal Receives: Other: Suction drain removal |
| Group 2: 50cc/24h | Experimental | This group represents the experimental value of drain output used to determine the timing of drain removal Receives: Other: Suction drain removal |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: At the time of patient discharge from the ward, usually up to 1 week
Secondary outcomes (1)
Seroma rate
The rate of seroma as wound complication, defined as an accumulation of serous fluid in the surgical space
Measured: Up to 6 weeks following surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2019
- Study startNov 2021 (estimated)
- Primary completionMar 2022 (estimated)
- Study completionJun 2022 (estimated)
Why it stopped: COVID pandemic
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Head and Neck NeoplasmsStudies of the same condition, open and under way.
- More trials run by Centre hospitalier de l'Université de Montréal (CHUM)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03971760
- Sponsor's protocol ID
- 18.300
- Status last verified
- Dec 2022
- First submitted
- 22 May 2019
- Last updated
- 8 Dec 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ideal Drainage Output of Post-operative Neck Suction Drain: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03971760
- Acronym / sponsor ID
- 18.300
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: COVID pandemic
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Centre hospitalier de l'Université de Montréal (CHUM)University, hospital or other
- Study start
- Nov 2021 (estimated)
- Primary completion
- Mar 2022 (estimated)
- Study completion
- Jun 2022 (estimated)
- First posted
- 3 Jun 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1: 30cc/24h | Active comparator | Other: Suction drain removalThis group represents the currently used value of drain output used to determine the timing of drain removal |
| Group 2: 50cc/24h | Experimental | Other: Suction drain removalThis group represents the experimental value of drain output used to determine the timing of drain removal |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Suction drain removalRemoval of negative pressure suction drain left in place to drain the surgical space after a neck surgery | Other | Group 1: 30cc/24h, Group 2: 50cc/24h |
Primary outcome
Duration of drainage
Time frame: At the time of patient discharge from the ward, usually up to 1 week
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
1 secondary outcome
Seroma rate
Time frame: Up to 6 weeks following surgery
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Dec 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Suction drain removal in people with Head and Neck Neoplasms and Drain Site Complication, run by Centre hospitalier de l'Université de Montréal (CHUM).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 8 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Duration of drainage (time frame: At the time of patient discharge from the ward, usually up to 1 week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Dec 2022.