Interest of Wicking for Ossicular Surgery and Myringoplasty

Last updated: July 5, 2022
Sponsor: University Hospital, Tours
Overall Status: Active - Recruiting

Phase

N/A

Condition

N/A

Treatment

N/A

Clinical Study ID

NCT05269368
DR210132-MECH-ORL
2021-A02788-33
221 A15
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Adult patient (age 18 = or + ), whose mother tongue is French or who understandsFrench language
  • Ossicular surgery (fitting of a partial or total ossicular prosthesis) ormyringoplasty performed endoscopically, from the speculum, from the duct or from theendaural.
  • Tympanic reconstruction by all types of grafts: cartilage, fascia, autologous fat
  • Written consent signed by the participant
  • Affiliation to a social security scheme,

Exclusion

Exclusion Criteria:

  • Pregnant or breastfeeding woman, patient under legal protection, guardianship orcuratorship.
  • Need for a retroauricular approach.
  • Need for annulus detachment> 60%
  • Presence of cholesteatoma or middle ear tumor

Study Design

Total Participants: 150
Study Start date:
May 16, 2022
Estimated Completion Date:
May 16, 2026

Study 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.

Connect with a study center

  • Hospital Blois

    Blois, 41000
    France

    Active - Recruiting

  • University Hospital BREST

    Brest, 29200
    France

    Site Not Available

  • Hospital Le Mans

    Le Mans, 72037
    France

    Active - Recruiting

  • University Hospital NANTES

    Nantes, 44000
    France

    Active - Recruiting

  • Hospital La Pitié Salpêtrière-APHP

    Paris, 75013
    France

    Active - Recruiting

  • University Hospital TOURS

    Tours, 37044
    France

    Active - Recruiting

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