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Ideal Drainage Output of Post-operative Neck Suction Drain

Ideal Drainage Output of Post-operative Neck Suction Drain: a Randomized Controlled Trial

Status
Withdrawn
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03971760
Enrollment
0
Registered
2019-06-03
Start date
2021-11-30
Completion date
2022-06-30
Last updated
2022-12-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Drain Site Complication, Head and Neck Neoplasms, Neck Dissection

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.

Interventions

OTHERSuction drain removal

Removal of negative pressure suction drain left in place to drain the surgical space after a neck surgery

Sponsors

Centre hospitalier de l'Université de Montréal (CHUM)
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Duration of drainageAt the time of patient discharge from the ward, usually up to 1 weekThe 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

MeasureTime frameDescription
Seroma rateUp to 6 weeks following surgeryThe rate of seroma as wound complication, defined as an accumulation of serous fluid in the surgical space

Other

MeasureTime frameDescription
Duration of admissionAt the time of patient discharge from the ward, usually up to 1 weekLength of patient's stay in hospital after surgery
Wound infectionUp to 6 weeks following surgerySurgical site infection following surgery

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026