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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05269368
Other study ID # DR210132-MECH-ORL
Secondary ID 2021-A02788-3322
Status Recruiting
Phase N/A
First received
Last updated
Start date May 16, 2022
Est. completion date May 16, 2026

Study information

Verified date July 2022
Source University Hospital, Tours
Contact Charles AUSSEDAT, MD
Phone +33247474747
Email c.aussedat@chu-tours.fr
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 150
Est. completion date May 16, 2026
Est. primary completion date May 16, 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Intervention

Procedure:
Wicking
Absorbable or non-absorbable wicking
No wicking
No wicking after surgery

Locations

Country Name City State
France Hospital Blois Blois
France University Hospital BREST Brest
France Hospital Le Mans Le Mans
France University Hospital NANTES Nantes
France Hospital La Pitié Salpêtrière-APHP Paris
France University Hospital TOURS Tours

Sponsors (1)

Lead Sponsor Collaborator
University Hospital, Tours

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Tympanic and external auditory canal healing Healing of tympanic membrane and external auditory canal, evaluated blindly by 3 experts, on an oto-endoscopy picture. Three months after intervention.
Secondary Audiometric results Audiometric results defined by the pure-tone average on 500, 1000, 2000 and 3000 Hz frequencies. Pre-operative, 3 months, 12 months
Secondary Post-operative satisfaction Visual Analogic scale (0-10 (min-max)) Immediate post-operative, day 7-10, day 30, 3 months
Secondary Post-operative pain Visual Analogic scale (0-10 (min-max)) Immediate post operative,day 7-10, day 30, 3 months
Secondary Post-operative quality of life Glasgow Benefit Inventory (-100 (min) to +100 (max)) Day 7-10, day 30, 3 months,12 months
Secondary Post-operative stress Perceived Stress Scale (PSS-10) 10-50 (min-max) Never to often Pre-operative, day 7-10, day 30, 3 months, 12 months
Secondary Operative time Operative time of the otology surgery, in minutes 30-120 minutes
Secondary Complications Questionnaire given to surgeons, allowing description of complications At any time of the follow-up,up to 1 year
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