Interest of Wicking for Ossicular Surgery and Myringoplasty (MECH-ORL)

Regional University Hospital Center (CHRU)

Status: Enrolling

Conditions: Post-Op Complication; Otologic Disease

Treatments: Procedure: No wicking; Procedure: Wicking

Study type: Interventional

Funder types: Other

Identifiers

NCT05269368

2021-A02788-33 (Registry Identifier)

DR210132-MECH-ORL

221 A15 (Other Identifier)

Details and patient eligibility

About

Myringoplasties and ossicular surgery are very common procedures. Following these otological surgeries, most surgeons install a wicking. This intervention consists of placing a wick, absorbable or not, in the external acoustic meatus, after having replaced the tympanomeatal flap.

Full description

Myringoplasties and ossicular surgery are very common procedures. Following these otological surgeries, most surgeons install a wicking. This intervention consists of placing a wick, absorbable or not, in the external acoustic meatus, after having replaced the tympanomeatal flap.

Putting in place a wicking often requires to remove this wicking, feared by the patient. In addition, wicking leads to obstruction of the external acoustic meatus responsible for functional discomfort (feeling of fullness in the ear, pain, significant conductive deafness) which can last from one to several weeks depending on the type of wicking.

Despite these drawbacks, the rationale for wicking has never been established, the choice of wick type is often empirical, and its necessity is sometimes controversial in the literature. Recent studies have studied the absence of wicking as an alternative to overcome its many drawbacks. No prospective, randomized, multicenter study has been performed to show the superiority of wicking in healing following middle ear surgery (myringoplasty, stapedo-vestibular ankylosis, ossiculoplasty) via the duct or the endaural route. The only study with a high level of evidence concerns only endoscopic surgery. This study has the advantage of showing that with comparable audiometric and healing results, the absence of wicking allows a reduced operating time, an earlier reduction in otorrhea and the feeling of blocked ears, and an earlier improvement of hearing. Given this work in the literature, our hypothesis is that tympanic healing is not impaired in the absence of wicking.

Enrollment: 150 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Adult patient (age 18 = or + ), whose mother tongue is French or who understands French language
• Ossicular surgery (fitting of a partial or total ossicular prosthesis) or myringoplasty performed endoscopically, from the speculum, from the duct or from the endaural.
• Tympanic reconstruction by all types of grafts: cartilage, fascia, autologous fat
• Written consent signed by the participant
• Affiliation to a social security scheme,

Exclusion criteria

• Pregnant or breastfeeding woman, patient under legal protection, guardianship or curatorship.
• Need for a retroauricular approach.
• Need for annulus detachment> 60%
• Presence of cholesteatoma or middle ear tumor

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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150 participants in 2 patient groups

No wicking

Experimental group

Description:

Absence of Wicking after intervention

Treatment:

Procedure: No wicking

Control

Active Comparator group

Description:

Wicking after intervention

Treatment:

Procedure: Wicking