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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Post-Op Complication; Otologic Disease
• Intervention / Treatment: Procedure: No wicking; Procedure: Wicking

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.

• Study Type: Interventional
• Enrollment (Anticipated): 150
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Wiebe de JONG, MSc; Phone Number: +33247474680; Email: w.dejong@chu-tours.fr
• Study Contact Backup: Name: Charles AUSSEDAT, MD; Phone Number: 74518 +33247474747; Email: c.aussedat@chu-tours.fr

Study Locations

• France
  • Blois, France, 41000
    • Recruiting
    • Hospital Blois
    • Contact: Charles-Edouard ROUF, MD-PhD; Phone Number: +33254556525; Email: charles.rouf@outlook.com
  • Brest, France, 29200
    • Active, not recruiting
    • University Hospital Brest
  • Le Mans, France, 72037
    • Recruiting
    • Hospital Le Mans
    • Contact: Catherine BOBIN, MD-PhD; Phone Number: +33243434325; Email: catherinebobin@gmail.com
  • Nantes, France, 44000
    • Recruiting
    • University Hospital Nantes
    • Contact: Guillaume MICHEL, MD-PhD; Phone Number: +33240083475; Email: guillaume.michel@chu-nantes.fr
  • Paris, France, 75013
    • Recruiting
    • Hospital La Pitié Salpêtrière-APHP
    • Contact: Daniele BERNARDESCHI, MD-PhD; Phone Number: +33142177440; Email: daniele.bernardeschi@aphp.fr
  • Tours, France, 37044
    • Recruiting
    • university hospital Tours
    • Contact: Charles AUSSEDAT, MD-PhD; Phone Number: +33218370523; Email: c.aussedat@chu-tours.fr
    • Contact: David BAKHOS, MD-PhD; Phone Number: +33218370523; Email: Bakhos.David@gmail.com
    • Sub-Investigator: David BAKHOS, MD-PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: No wicking; Absence of Wicking after intervention	Procedure: No wicking; No wicking after surgery
Active Comparator: Control; Wicking after intervention	Procedure: Wicking; Absorbable or non-absorbable wicking

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Audiometric results	Audiometric results defined by the pure-tone average on 500, 1000, 2000 and 3000 Hz frequencies.	Pre-operative, 3 months, 12 months
Post-operative satisfaction	Visual Analogic scale (0-10 (min-max))	Immediate post-operative, day 7-10, day 30, 3 months
Post-operative pain	Visual Analogic scale (0-10 (min-max))	Immediate post operative,day 7-10, day 30, 3 months
Post-operative quality of life	Glasgow Benefit Inventory (-100 (min) to +100 (max))	Day 7-10, day 30, 3 months,12 months
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
Operative time	Operative time of the otology surgery, in minutes	30-120 minutes
Complications	Questionnaire given to surgeons, allowing description of complications	At any time of the follow-up,up to 1 year

Collaborators and Investigators

• Sponsor: University Hospital, Tours
• Investigators: Study Director: Charles AUSSEDAT, MD, University hospital of Tours

Study record dates

Study Major Dates

• Study Start (Actual): May 16, 2022
• Primary Completion (Anticipated): May 16, 2025
• Study Completion (Anticipated): May 16, 2026

Study Registration Dates

• First Submitted: January 21, 2022
• First Submitted That Met QC Criteria: March 1, 2022
• First Posted (Actual): March 8, 2022

Study Record Updates

• Last Update Posted (Actual): July 6, 2022
• Last Update Submitted That Met QC Criteria: July 5, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Keywords: Ossicular surgery; Otological surgeries; Wicking
• Additional Relevant MeSH Terms: Pathologic Processes; Otorhinolaryngologic Diseases; Postoperative Complications; Ear Diseases
• Other Study ID Numbers: DR210132-MECH-ORL; 2021-A02788-33 (Registry Identifier: Id-RCB-ANSM-France); 221 A15 (Other Identifier: Comité de Protection des Personnes Sud-Méditerranée II)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No