Interest of Wicking for Ossicular Surgery and Myringoplasty

Post-Op Complication Clinical Trial

— MECH-ORL  

Official title:

Intérêt du méchage Pour la Chirurgie Ossiculaire et la Myringoplastie : Essai contrôlé randomisé Multicentrique de Non-infériorité

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
• 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
• 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

Related Conditions & MeSH terms

• Ear Diseases
• Otologic Disease
• Post-Op Complication
• Postoperative Complications

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