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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
SINGLE
Enrollment
150
Absorbable or non-absorbable wicking
No wicking after surgery
Hospital Blois
Blois, France
RECRUITINGUniversity Hospital BREST
Brest, France
ACTIVE_NOT_RECRUITINGHospital Le Mans
Le Mans, France
RECRUITINGTympanic and external auditory canal healing
Healing of tympanic membrane and external auditory canal, evaluated blindly by 3 experts, on an oto-endoscopy picture.
Time frame: Three months after intervention.
Audiometric results
Audiometric results defined by the pure-tone average on 500, 1000, 2000 and 3000 Hz frequencies.
Time frame: Pre-operative, 3 months, 12 months
Post-operative satisfaction
Visual Analogic scale (0-10 (min-max))
Time frame: Immediate post-operative, day 7-10, day 30, 3 months
Post-operative pain
Visual Analogic scale (0-10 (min-max))
Time frame: Immediate post operative,day 7-10, day 30, 3 months
Post-operative quality of life
Glasgow Benefit Inventory (-100 (min) to +100 (max))
Time frame: Day 7-10, day 30, 3 months,12 months
Post-operative stress
Perceived Stress Scale (PSS-10) 10-50 (min-max) Never to often
Time frame: Pre-operative, day 7-10, day 30, 3 months, 12 months
Operative time
Operative time of the otology surgery, in minutes
Time frame: 30-120 minutes
Complications
Questionnaire given to surgeons, allowing description of complications
Time frame: At any time of the follow-up,up to 1 year
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University Hospital NANTES
Nantes, France
RECRUITINGHospital La Pitié Salpêtrière-APHP
Paris, France
RECRUITINGUniversity Hospital TOURS
Tours, France
RECRUITING