NCT05269368

Brief 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P75+ for not_applicable

Timeline
1mo left

Started May 2022

Longer than P75 for not_applicable

Geographic Reach
1 country

6 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress99%
May 2022May 2026

First Submitted

Initial submission to the registry

January 21, 2022

Completed
2 months until next milestone

First Posted

Study publicly available on registry

March 8, 2022

Completed
2 months until next milestone

Study Start

First participant enrolled

May 16, 2022

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 16, 2025

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

May 16, 2026

Expected
Last Updated

July 6, 2022

Status Verified

July 1, 2022

Enrollment Period

3 years

First QC Date

January 21, 2022

Last Update Submit

July 5, 2022

Conditions

Post-Op ComplicationOtologic Disease

Keywords

Ossicular surgeryOtological surgeriesWicking

Outcome Measures

Primary Outcomes (1)

  • 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.

Secondary Outcomes (7)

  • Audiometric results

    Pre-operative, 3 months, 12 months

  • Post-operative satisfaction

    Immediate post-operative, day 7-10, day 30, 3 months

  • Post-operative pain

    Immediate post operative,day 7-10, day 30, 3 months

  • Post-operative quality of life

    Day 7-10, day 30, 3 months,12 months

  • Post-operative stress

    Pre-operative, day 7-10, day 30, 3 months, 12 months

  • +2 more secondary outcomes

Study Arms (2)

No wicking

EXPERIMENTAL

Absence of Wicking after intervention

Procedure: No wicking

Control

ACTIVE COMPARATOR

Wicking after intervention

Procedure: Wicking

Interventions

WickingPROCEDURE

Absorbable or non-absorbable wicking

Control
No wickingPROCEDURE

No wicking after surgery

No wicking

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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,

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Hospital Blois

Blois, 41000, France

RECRUITING

University Hospital BREST

Brest, 29200, France

ACTIVE NOT RECRUITING

Hospital Le Mans

Le Mans, 72037, France

RECRUITING

University Hospital NANTES

Nantes, 44000, France

RECRUITING

Hospital La Pitié Salpêtrière-APHP

Paris, 75013, France

RECRUITING

University Hospital TOURS

Tours, 37044, France

RECRUITING

MeSH Terms

Conditions

Postoperative ComplicationsEar Diseases

Interventions

Capillary Action

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and SymptomsOtorhinolaryngologic Diseases

Intervention Hierarchy (Ancestors)

Surface PropertiesChemical Phenomena

Study Officials

  • Charles AUSSEDAT, MD

    University Hospital of TOURS

    STUDY DIRECTOR

Central Study Contacts

Charles AUSSEDAT, MD

CONTACT

+33247474747c.aussedat@chu-tours.fr

Wiebe de JONG, MSc

CONTACT

+33247474680w.dejong@chu-tours.fr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Three experts, independent of the study, will examine the photos three months after the intervention using a standardized evaluation grid based on 10 criteria.
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: * Experimental group: No Wicking * Control groupe: Wicking after intervention
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 21, 2022

First Posted

March 8, 2022

Study Start

May 16, 2022

Primary Completion

May 16, 2025

Study Completion (Estimated)

May 16, 2026

Last Updated

July 6, 2022

Record last verified: 2022-07

Data Sharing

IPD Sharing
Will not share

Locations

FR(6)