Evaluating the use of wicking in ear surgeries
Intérêt du méchage Pour la Chirurgie Ossiculaire et la Myringoplastie : Essai contrôlé randomisé Multicentrique de Non-infériorité
This study is testing if using wicking during ear surgeries helps patients recover better and feel less discomfort compared to those who don’t use it.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 150 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University Hospital, Tours Academic / other |
| Locations | 6 sites (Blois and 5 other locations) |
| Trial ID | NCT05269368 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the necessity and effectiveness of using wicking in myringoplasties and ossicular surgeries. It compares outcomes between patients who receive a wicking and those who do not, focusing on post-operative complications and recovery times. The study aims to determine if avoiding wicking can lead to better patient experiences and outcomes, such as reduced discomfort and improved hearing. It is a prospective, randomized, multicenter trial involving multiple hospitals.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older who are undergoing endoscopic ossicular surgery or myringoplasty and understand French.
Not a fit: Patients requiring a retroauricular approach or those with specific ear conditions like cholesteatoma may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved recovery experiences and outcomes for patients undergoing ear surgeries.
How similar studies have performed: While some studies have explored the absence of wicking, this is the first prospective, randomized, multicenter study specifically addressing this issue in middle ear surgeries.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Blois and 5 other locations
- Hospital Blois — Blois, France (Recruiting)
- University Hospital BREST — Brest, France (Active_not_recruiting)
- Hospital Le Mans — Le Mans, France (Recruiting)
- University Hospital NANTES — Nantes, France (Recruiting)
- Hospital La Pitié Salpêtrière-APHP — Paris, France (Recruiting)
- University Hospital TOURS — Tours, France (Recruiting)
Study contacts
- Study coordinator: Charles AUSSEDAT, MD
- Email: c.aussedat@chu-tours.fr
- Phone: +33247474747
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.