Post-Op ComplicationMECH-ORLNCT05269368
Interest of Wicking for Ossicular Surgery and Myringoplasty
A study testing Wicking and No wicking in people with Post-Op Complication and Otologic Disease, run by University Hospital, Tours at 6 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Post-Op Complication, Otologic Disease
- What is being tested?
- Wicking and No wicking
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 6 sitesFrance
- Study dates
- 16 May 2022to 16 May 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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,
Who cannot join
- 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
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
France6 sites, 5 recruiting
- Recruiting
Hospital Blois
Blois, 41000
Charles-Edouard ROUF, MD-PhD, +33254556525, charles.rouf@outlook.com
- Active, not recruiting
University Hospital BREST
Brest, 29200
- Recruiting
Hospital Le Mans
Le Mans, 72037
Catherine BOBIN, MD-PhD, +33243434325, catherinebobin@gmail.com
- Recruiting
University Hospital NANTES
Nantes, 44000
Guillaume MICHEL, MD-PhD, +33240083475, guillaume.michel@chu-nantes.fr
- Recruiting
Hospital La Pitié Salpêtrière-APHP
Paris, 75013
Daniele BERNARDESCHI, MD-PhD, +33142177440, daniele.bernardeschi@aphp.fr
- Recruiting
University Hospital TOURS
Tours, 37044
Charles AUSSEDAT, MD-PhD, +33218370523, c.aussedat@chu-tours.fr
David BAKHOS, MD-PhD, +33218370523, Bakhos.David@gmail.com
About this study
Official title: 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.
Read the 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.
- Conditions
- Post-Op Complication, Otologic Disease
- Being tested
- Wicking, No wicking
- Keywords
- Ossicular surgery, Otological surgeries, Wicking
- Medical subject headings
- Postoperative Complications, Ear Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
WickingProcedure or surgery
Absorbable or non-absorbable wicking
No wickingProcedure or surgery
No wicking after surgery
| Study group | Role | What they receive |
|---|---|---|
| No wicking | Experimental | Absence of Wicking after intervention Receives: Procedure: No wicking |
| Control | Active comparator | Wicking after intervention Receives: Procedure: Wicking |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tympanic and external auditory canal healing
Healing of tympanic membrane and external auditory canal, evaluated blindly by 3 experts, on an oto-endoscopy picture.
Measured: Three months after intervention.
Secondary outcomes (7)
Audiometric results
Audiometric results defined by the pure-tone average on 500, 1000, 2000 and 3000 Hz frequencies.
Measured: Pre-operative, 3 months, 12 months
Post-operative satisfaction
Visual Analogic scale (0-10 (min-max))
Measured: Immediate post-operative, day 7-10, day 30, 3 months
Post-operative pain
Visual Analogic scale (0-10 (min-max))
Measured: Immediate post operative,day 7-10, day 30, 3 months
Post-operative quality of life
Glasgow Benefit Inventory (-100 (min) to +100 (max))
Measured: Day 7-10, day 30, 3 months,12 months
Post-operative stress
Perceived Stress Scale (PSS-10) 10-50 (min-max) Never to often
Measured: Pre-operative, day 7-10, day 30, 3 months, 12 months
Operative time
Operative time of the otology surgery, in minutes
Measured: 30-120 minutes
Complications
Questionnaire given to surgeons, allowing description of complications
Measured: At any time of the follow-up,up to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2022
- Study start16 May 2022
- Primary completion16 May 2025 (estimated)
- Study completion16 May 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post-Op ComplicationStudies of the same condition, open and under way.
- More trials run by University Hospital, ToursThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- * Experimental group: No Wicking * Control groupe: Wicking after intervention
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Tours
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Charles AUSSEDAT, MD, Study director, University Hospital of TOURS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05269368
- Sponsor's protocol ID
- DR210132-MECH-ORL
- Other IDs
- 2021-A02788-33, 221 A15
- Acronym
- MECH-ORL
- Status last verified
- Jul 2022
- First submitted
- 21 Jan 2022
- Last updated
- 6 Jul 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intérêt du méchage Pour la Chirurgie Ossiculaire et la Myringoplastie : Essai contrôlé randomisé Multicentrique de Non-infériorité
- ClinicalTrials.gov ID
- NCT05269368
- Acronym / sponsor ID
- MECH-ORL / DR210132-MECH-ORL
- Conditions
- Post-Op Complication, Otologic Disease
- Keywords
- Ossicular surgery, Otological surgeries, Wicking
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- University Hospital, ToursUniversity, hospital or other
- Study start
- 16 May 2022 (actual)
- Primary completion
- 16 May 2025 (estimated)
- Study completion
- 16 May 2026 (estimated)
- First posted
- 8 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- * Experimental group: No Wicking * Control groupe: Wicking after intervention
| Arm | Type | Receives |
|---|---|---|
| No wicking | Experimental | Procedure: No wickingAbsence of Wicking after intervention |
| Control | Active comparator | Procedure: WickingWicking after intervention |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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,
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| WickingAbsorbable or non-absorbable wicking | Procedure or surgery | Control |
| No wickingNo wicking after surgery | Procedure or surgery | No wicking |
Primary outcome
Tympanic and external auditory canal healing
Time frame: Three months after intervention.
Healing of tympanic membrane and external auditory canal, evaluated blindly by 3 experts, on an oto-endoscopy picture.
7 secondary outcomes
Audiometric results
Time frame: Pre-operative, 3 months, 12 months
Post-operative satisfaction
Time frame: Immediate post-operative, day 7-10, day 30, 3 months
Post-operative pain
Time frame: Immediate post operative,day 7-10, day 30, 3 months
Post-operative quality of life
Time frame: Day 7-10, day 30, 3 months,12 months
Post-operative stress
Time frame: Pre-operative, day 7-10, day 30, 3 months, 12 months
Operative time
Time frame: 30-120 minutes
Complications
Time frame: At any time of the follow-up,up to 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jul 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Charles AUSSEDAT, MD study director
University Hospital of TOURS
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Wicking and No wicking in people with Post-Op Complication and Otologic Disease, run by University Hospital, Tours at 6 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Charles AUSSEDAT, MD (+33247474747 ext. 74518, c.aussedat@chu-tours.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Tympanic and external auditory canal healing (time frame: Three months after intervention.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jul 2022.