Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2021-A02788-33 | Registry Identifier | Id-RCB-ANSM-France | |
| 221 A15 | Other Identifier | Comité de Protection des Personnes Sud-Méditerranée II |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| No wicking | Experimental | Absence of Wicking after intervention |
|
| Control | Active Comparator | Wicking after intervention |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Wicking | Procedure | Absorbable or non-absorbable wicking |
| |
| No wicking |
| 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. |
| 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)) |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Charles AUSSEDAT, MD | Contact | +33247474747 | 74518 | c.aussedat@chu-tours.fr |
| Wiebe de JONG, MSc | Contact | +33247474680 | w.dejong@chu-tours.fr |
| Name | Affiliation | Role |
|---|---|---|
| Charles AUSSEDAT, MD | University Hospital of TOURS | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Blois | Recruiting | Blois | 41000 | France |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D004427 | Ear Diseases |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010038 | Otorhinolaryngologic Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D002197 | Capillary Action |
| ID | Term |
|---|---|
| D013499 | Surface Properties |
| D055598 | Chemical Phenomena |
Not provided
Not provided
Not provided
Not provided
Three experts, independent of the study, will examine the photos three months after the intervention using a standardized evaluation grid based on 10 criteria.
| Procedure |
No wicking after surgery |
|
| 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 |
| University Hospital BREST | Active, not recruiting | Brest | 29200 | France |
| Hospital Le Mans | Recruiting | Le Mans | 72037 | France |
|
| University Hospital NANTES | Recruiting | Nantes | 44000 | France |
|
| Hospital La Pitié Salpêtrière-APHP | Recruiting | Paris | 75013 | France |
|
| University Hospital TOURS | Recruiting | Tours | 37044 | France |
|