Interest of Wicking for Ossicular Surgery and Myringoplasty

Not Applicable

Recruiting

• Conditions: Otologic Disease; Post-Op Complication
• Interventions: Procedure: No wicking; Procedure: Wicking

• Registration Number: NCT05269368
• Lead Sponsor: University Hospital, Tours

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.

Study Timeline

• Study First Submitted: 2022-01-21
• Study First Submitted QC: 2022-03-01
• Study First Posted: 2022-03-08
• Study Start: 2022-05-16
• Status Verified: 2022-07
• Last Update Submitted: 2022-07-05
• Last Update Posted: 2022-07-06
• Primary Completion: 2025-05-16
• Study Completion: 2026-05-16

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 150

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
No wicking	No wicking	Absence of Wicking after intervention
Control	Wicking	Wicking after intervention

Primary Outcome Measures

Name	Time	Method
Tympanic and external auditory canal healing	Three months after intervention.	Healing of tympanic membrane and external auditory canal, evaluated blindly by 3 experts, on an oto-endoscopy picture.

Secondary Outcome Measures

Name	Time	Method
Audiometric results	Pre-operative, 3 months, 12 months	Audiometric results defined by the pure-tone average on 500, 1000, 2000 and 3000 Hz frequencies.
Post-operative stress	Pre-operative, day 7-10, day 30, 3 months, 12 months	Perceived Stress Scale (PSS-10) 10-50 (min-max) Never to often
Post-operative pain	Immediate post operative,day 7-10, day 30, 3 months	Visual Analogic scale (0-10 (min-max))
Post-operative satisfaction	Immediate post-operative, day 7-10, day 30, 3 months	Visual Analogic scale (0-10 (min-max))
Operative time	30-120 minutes	Operative time of the otology surgery, in minutes
Complications	At any time of the follow-up,up to 1 year	Questionnaire given to surgeons, allowing description of complications
Post-operative quality of life	Day 7-10, day 30, 3 months,12 months	Glasgow Benefit Inventory (-100 (min) to +100 (max))

Trial Locations

Locations (6)

University Hospital NANTES; 🇫🇷 Nantes, France

Hospital Le Mans; 🇫🇷 Le Mans, France

Hospital Blois; 🇫🇷 Blois, France

Hospital La Pitié Salpêtrière-APHP; 🇫🇷 Paris, France

University Hospital BREST; 🇫🇷 Brest, France

University Hospital TOURS; 🇫🇷 Tours, France