Ideal Drainage Output of Post-operative Neck Suction Drain

Head and Neck Neoplasms Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03971760
• Other study ID #: 18.300
• Status: Withdrawn
• Phase: N/A
• Start date: November 2021
• Est. completion date: June 2022

Study information

• Verified date: December 2022
• Source: Centre hospitalier de l'Université de Montréal (CHUM)
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: June 2022
• Est. primary completion date: March 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Drain Site Complication
• Head and Neck Neoplasms
• Neck Dissection

Intervention

Other:
• Suction drain removal
Removal of negative pressure suction drain left in place to drain the surgical space after a neck surgery

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Centre hospitalier de l'Université de Montréal (CHUM)

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	Wound infection	Surgical site infection following surgery	Up to 6 weeks following surgery
Primary	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	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