Clinical trial NCT05269368: Interest of Wicking for Ossicular Surgery and Myringoplasty
Official title: Intérêt du méchage Pour la Chirurgie Ossiculaire et la Myringoplastie : Essai contrôlé randomisé Multicentrique de Non-infériorité
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Post-Op Complication
Otologic Disease
Keywords: Ossicular surgery
Otological surgeries
Wicking
Lead sponsor: University Hospital, Tours
Sponsor class: OTHER
First posted: 2022-03-08
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: * Experimental group: No Wicking
* Control groupe: Wicking after intervention
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Tympanic and external auditory canal healing
timeFrame: Three months after intervention.
Secondary outcomes:
measure: Audiometric results
timeFrame: Pre-operative, 3 months, 12 months
measure: Post-operative satisfaction
timeFrame: Immediate post-operative, day 7-10, day 30, 3 months
measure: Post-operative pain
timeFrame: Immediate post operative,day 7-10, day 30, 3 months
measure: Post-operative quality of life
timeFrame: Day 7-10, day 30, 3 months,12 months
measure: Post-operative stress
timeFrame: Pre-operative, day 7-10, day 30, 3 months, 12 months
measure: Operative time
timeFrame: 30-120 minutes
measure: Complications
timeFrame: At any time of the follow-up,up to 1 year
Other outcomes:
Locations:
city: Blois
country: France
facility: Hospital Blois
city: Brest
country: France
facility: University Hospital BREST
city: Le Mans
country: France
facility: Hospital Le Mans
city: Nantes
country: France
facility: University Hospital NANTES
city: Paris
country: France
facility: Hospital La Pitié Salpêtrière-APHP
city: Tours
country: France
facility: University Hospital TOURS
Study officials:
affiliation: University Hospital of TOURS
name: Charles AUSSEDAT, MD
role: STUDY_DIRECTOR
References: