Ideal Drainage Output of Post-operative Neck Suction Drain

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.

Study Overview

• Status: Withdrawn
• Conditions: Head and Neck Neoplasms; Drain Site Complication; Neck Dissection
• Intervention / Treatment: Other: Suction drain removal

• Study Type: Interventional
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Group 1: 30cc/24h; This group represents the currently used value of drain output used to determine the timing of drain removal	Other: Suction drain removal; Removal of negative pressure suction drain left in place to drain the surgical space after a neck surgery
Experimental: Group 2: 50cc/24h; This group represents the experimental value of drain output used to determine the timing of drain removal	Other: Suction drain removal; Removal of negative pressure suction drain left in place to drain the surgical space after a neck surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Seroma rate	The rate of seroma as wound complication, defined as an accumulation of serous fluid in the surgical space	Up to 6 weeks following surgery

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Duration of admission	Length of patient's stay in hospital after surgery	At the time of patient discharge from the ward, usually up to 1 week
Wound infection	Surgical site infection following surgery	Up to 6 weeks following surgery

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Anticipated): November 1, 2021
• Primary Completion (Anticipated): March 1, 2022
• Study Completion (Anticipated): June 1, 2022

Study Registration Dates

• First Submitted: May 22, 2019
• First Submitted That Met QC Criteria: May 30, 2019
• First Posted (Actual): June 3, 2019

Study Record Updates

• Last Update Posted (Estimate): December 8, 2022
• Last Update Submitted That Met QC Criteria: December 6, 2022
• Last Verified: December 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Neoplasms by Site; Head and Neck Neoplasms
• Other Study ID Numbers: 18.300

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No