Ignite Creation Date:
2025-12-24 @ 6:28 PM
Ignite Modification Date:
2025-12-25 @ 3:58 PM
Study NCT ID:
NCT05269368
Status:
RECRUITING
Last Update Posted:
2022-07-06
First Post:
2022-01-21
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Interest of Wicking for Ossicular Surgery and Myringoplasty
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011183', 'term': 'Postoperative Complications'}, {'id': 'D004427', 'term': 'Ear Diseases'}], 'ancestors': [{'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D010038', 'term': 'Otorhinolaryngologic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D002197', 'term': 'Capillary Action'}], 'ancestors': [{'id': 'D013499', 'term': 'Surface Properties'}, {'id': 'D055598', 'term': 'Chemical Phenomena'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR'], 'maskingDescription': 'Three experts, independent of the study, will examine the photos three months after the intervention using a standardized evaluation grid based on 10 criteria.'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL', 'interventionModelDescription': '* Experimental group: No Wicking\n* Control groupe: Wicking after intervention'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 150}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-05-16', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-07', 'completionDateStruct': {'date': '2026-05-16', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-07-05', 'studyFirstSubmitDate': '2022-01-21', 'studyFirstSubmitQcDate': '2022-03-01', 'lastUpdatePostDateStruct': {'date': '2022-07-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-03-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-05-16', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Tympanic and external auditory canal healing', 'timeFrame': 'Three months after intervention.', 'description': 'Healing of tympanic membrane and external auditory canal, evaluated blindly by 3 experts, on an oto-endoscopy picture.'}], 'secondaryOutcomes': [{'measure': 'Audiometric results', 'timeFrame': 'Pre-operative, 3 months, 12 months', 'description': 'Audiometric results defined by the pure-tone average on 500, 1000, 2000 and 3000 Hz frequencies.'}, {'measure': 'Post-operative satisfaction', 'timeFrame': 'Immediate post-operative, day 7-10, day 30, 3 months', 'description': 'Visual Analogic scale (0-10 (min-max))'}, {'measure': 'Post-operative pain', 'timeFrame': 'Immediate post operative,day 7-10, day 30, 3 months', 'description': 'Visual Analogic scale (0-10 (min-max))'}, {'measure': 'Post-operative quality of life', 'timeFrame': 'Day 7-10, day 30, 3 months,12 months', 'description': 'Glasgow Benefit Inventory (-100 (min) to +100 (max))'}, {'measure': 'Post-operative stress', 'timeFrame': 'Pre-operative, day 7-10, day 30, 3 months, 12 months', 'description': 'Perceived Stress Scale (PSS-10) 10-50 (min-max) Never to often'}, {'measure': 'Operative time', 'timeFrame': '30-120 minutes', 'description': 'Operative time of the otology surgery, in minutes'}, {'measure': 'Complications', 'timeFrame': 'At any time of the follow-up,up to 1 year', 'description': 'Questionnaire given to surgeons, allowing description of complications'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Ossicular surgery', 'Otological surgeries', 'Wicking'], 'conditions': ['Post-Op Complication', 'Otologic Disease']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.\n\nPutting 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.\n\nDespite 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult patient (age 18 = or + ), whose mother tongue is French or who understands French language\n* Ossicular surgery (fitting of a partial or total ossicular prosthesis) or myringoplasty performed endoscopically, from the speculum, from the duct or from the endaural.\n* Tympanic reconstruction by all types of grafts: cartilage, fascia, autologous fat\n* Written consent signed by the participant\n* Affiliation to a social security scheme,\n\nExclusion Criteria:\n\n* Pregnant or breastfeeding woman, patient under legal protection, guardianship or curatorship.\n* Need for a retroauricular approach.\n* Need for annulus detachment\\> 60%\n* Presence of cholesteatoma or middle ear tumor'}, 'identificationModule': {'nctId': 'NCT05269368', 'acronym': 'MECH-ORL', 'briefTitle': 'Interest of Wicking for Ossicular Surgery and Myringoplasty', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Tours'}, 'officialTitle': 'Intérêt du méchage Pour la Chirurgie Ossiculaire et la Myringoplastie : Essai contrôlé randomisé Multicentrique de Non-infériorité', 'orgStudyIdInfo': {'id': 'DR210132-MECH-ORL'}, 'secondaryIdInfos': [{'id': '2021-A02788-33', 'type': 'REGISTRY', 'domain': 'Id-RCB-ANSM-France'}, {'id': '221 A15', 'type': 'OTHER', 'domain': 'Comité de Protection des Personnes Sud-Méditerranée II'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'No wicking', 'description': 'Absence of Wicking after intervention', 'interventionNames': ['Procedure: No wicking']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Control', 'description': 'Wicking after intervention', 'interventionNames': ['Procedure: Wicking']}], 'interventions': [{'name': 'Wicking', 'type': 'PROCEDURE', 'description': 'Absorbable or non-absorbable wicking', 'armGroupLabels': ['Control']}, {'name': 'No wicking', 'type': 'PROCEDURE', 'description': 'No wicking after surgery', 'armGroupLabels': ['No wicking']}]}, 'contactsLocationsModule': {'locations': [{'zip': '41000', 'city': 'Blois', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Charles-Edouard ROUF, MD-PhD', 'role': 'CONTACT', 'email': 'charles.rouf@outlook.com', 'phone': '+33254556525'}], 'facility': 'Hospital Blois', 'geoPoint': {'lat': 47.59432, 'lon': 1.32912}}, {'zip': '29200', 'city': 'Brest', 'status': 'ACTIVE_NOT_RECRUITING', 'country': 'France', 'facility': 'University Hospital BREST', 'geoPoint': {'lat': 48.39029, 'lon': -4.48628}}, {'zip': '72037', 'city': 'Le Mans', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Catherine BOBIN, MD-PhD', 'role': 'CONTACT', 'email': 'catherinebobin@gmail.com', 'phone': '+33243434325'}], 'facility': 'Hospital Le Mans', 'geoPoint': {'lat': 48.0021, 'lon': 0.20251}}, {'zip': '44000', 'city': 'Nantes', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Guillaume MICHEL, MD-PhD', 'role': 'CONTACT', 'email': 'guillaume.michel@chu-nantes.fr', 'phone': '+33240083475'}], 'facility': 'University Hospital NANTES', 'geoPoint': {'lat': 47.21725, 'lon': -1.55336}}, {'zip': '75013', 'city': 'Paris', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Daniele BERNARDESCHI, MD-PhD', 'role': 'CONTACT', 'email': 'daniele.bernardeschi@aphp.fr', 'phone': '+33142177440'}], 'facility': 'Hospital La Pitié Salpêtrière-APHP', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '37044', 'city': 'Tours', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Charles AUSSEDAT, MD-PhD', 'role': 'CONTACT', 'email': 'c.aussedat@chu-tours.fr', 'phone': '+33218370523'}, {'name': 'David BAKHOS, MD-PhD', 'role': 'CONTACT', 'email': 'Bakhos.David@gmail.com', 'phone': '+33218370523'}, {'name': 'David BAKHOS, MD-PhD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'University Hospital TOURS', 'geoPoint': {'lat': 47.39484, 'lon': 0.70398}}], 'centralContacts': [{'name': 'Charles AUSSEDAT, MD', 'role': 'CONTACT', 'email': 'c.aussedat@chu-tours.fr', 'phone': '+33247474747', 'phoneExt': '74518'}, {'name': 'Wiebe de JONG, MSc', 'role': 'CONTACT', 'email': 'w.dejong@chu-tours.fr', 'phone': '+33247474680'}], 'overallOfficials': [{'name': 'Charles AUSSEDAT, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'University Hospital of TOURS'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Tours', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}