Ideal Drainage Output of Post-operative Neck Suction Drain

NCT ID: NCT03971760

Last Updated: 2022-12-08

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-11-30
• Study Completion Date: 2022-06-30

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Group 1: 30cc/24h

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

Group Type: ACTIVE_COMPARATOR

Suction drain removal

Intervention Type: OTHER

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

Group 2: 50cc/24h

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

Group Type: EXPERIMENTAL

Suction drain removal

Intervention Type: OTHER

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

Interventions

Suction drain removal

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

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Centre hospitalier de l'Université de Montréal (CHUM)

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

18.300

Identifier Type: -

Identifier Source: org_study_id