Ideal Drainage Output of Post-operative Neck Suction Drain

NCT03971760 | Withdrawn

• 1 other identifier: 18.300
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Head and Neck Neoplasms; Drain Site Complication; Neck Dissection

Outcome Measures

Primary Outcomes (1)

• 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

  At the time of patient discharge from the ward, usually up to 1 week

Secondary Outcomes (1)

• Seroma rate

  Up to 6 weeks following surgery

Other Outcomes (2)

• Duration of admission

  At the time of patient discharge from the ward, usually up to 1 week

• Wound infection

  Up to 6 weeks following surgery

Study Arms (2)

Group 1: 30cc/24h

ACTIVE COMPARATOR

This group represents the currently used value of drain output used to determine the timing of drain removal

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

Other: Suction drain removal

Interventions

Suction drain removal OTHER

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

Group 1: 30cc/24h; Group 2: 50cc/24h

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre hospitalier de l'Université de Montréal (CHUM): lead

MeSH Terms

Conditions

Head and Neck Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 22, 2019
• First Posted: June 3, 2019
• Study Start: November 1, 2021
• Primary Completion: March 1, 2022
• Study Completion: June 1, 2022
• Last Updated: December 8, 2022

Record last verified: 2022-12