An interventional study of Wicking and No wicking in Post-Op Complication and Otologic Disease, sponsored by University Hospital, Tours. Recruiting at 6 sites in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-07-06.
Sponsored by University Hospital, Tours · Not applicable, Interventional, and Supportive care
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.
1,332 studies on the registry are indexed under Postoperative Complications; 311 are open to participants now.
This study's planned enrollment of 150 is above the median of 114 across 766 interventional studies indexed under Postoperative Complications.
Browse Postoperative Complications studies →University Hospital, Tours is the lead sponsor of 307 studies on the registry; 79 are open to participants now.
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Exclusion Criteria:
Absence of Wicking after intervention
Procedure: No wicking
Wicking after intervention
Procedure: Wicking
Absorbable or non-absorbable wicking
No wicking after surgery
Tympanic and external auditory canal healing
Healing of tympanic membrane and external auditory canal, evaluated blindly by 3 experts, on an oto-endoscopy picture.
Time frame: Three months after intervention.
Audiometric results
Audiometric results defined by the pure-tone average on 500, 1000, 2000 and 3000 Hz frequencies.
Time frame: Pre-operative, 3 months, 12 months
Post-operative satisfaction
Visual Analogic scale (0-10 (min-max))
Time frame: Immediate post-operative, day 7-10, day 30, 3 months
Post-operative pain
Visual Analogic scale (0-10 (min-max))
Time frame: Immediate post operative,day 7-10, day 30, 3 months
Post-operative quality of life
Glasgow Benefit Inventory (-100 (min) to +100 (max))
Time frame: Day 7-10, day 30, 3 months,12 months
Post-operative stress
Perceived Stress Scale (PSS-10) 10-50 (min-max) Never to often
Time frame: Pre-operative, day 7-10, day 30, 3 months, 12 months
Operative time
Operative time of the otology surgery, in minutes
Time frame: 30-120 minutes
Complications
Questionnaire given to surgeons, allowing description of complications
Time frame: At any time of the follow-up,up to 1 year
Not enrolling at this site.
Plan to share: No
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