Clinical Survey of Oticon Medical Healing Cap

C51 - Clinical Survey of Oticon Medical Healing Cap

This study investigates the use of a new healing cap which, through altered design and choice of material, has been improved when it comes to minimizing the risk of it falling off as well as increasing patient comfort.

Study Overview

• Status: Completed
• Conditions: Conductive Hearing Loss; Mixed Hearing Loss; Unilateral Partial Deafness
• Intervention / Treatment: Device: Healing cap II

Detailed Description

This study will primarily investigate the use of a new healing cap, Healing cap II. The new healing cap has the same function as previous healing caps, but it soft instead of hard. Due to this, the healing cap is anticipated to not fall off as easily, but at the same time does not risk transferring larger forces than previously to the implant. Secondly, the patients will start using the sound processor 1-2 weeks after surgery. The implant stability will be monitored before and after loading by the use of resonance frequency analysis, an established method to evaluate and monitor osseointegrated implants.

• Study Type: Interventional
• Enrollment (Actual): 32
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Denmark
  • Aalborg, Denmark, 9000
    • Department of Oto-Rhino-Laryngology & Audiology, Aalborg University Hospital
  • Hellerup
    • Gentofte, Hellerup, Denmark, 2900
      • Dept. of Otolaryngology - Head & Neck Surgery and Audiology, Gentofte/Rigshospitalet

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Patients eligible for treatment with a bone anchored hearing aid
• 18 years or older

Exclusion Criteria:

• Inability to participate in follow-up
• Diseases or treatments known to compromise the bone quality at the implant site, e.g. radiotherapy, osteoporosis, diabetes mellitus.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: SUPPORTIVE_CARE
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Use of Healing cap II; Single arm study using a new healing cap as intervention	Device: Healing cap II; Healing cap II is used instead of the traditional healing cap as part of the surgical dressing after bone anchored hearing aid implant surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Skin reactions according to Holgers	Focus is on healing, post-operative complications and skin reactions after the first 7-14 days after surgery.	At time of sugical follow up visit (visit window of 7-14 days after surgery)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Fitting of sound processor at surgical follow-up visit	Implant stability is monitored before and after sound processor fitting through ISQ and clinical assessments.	At time of surgical follow up visit (visit window of 7-14 days after surgery)

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Surgical time	Time taken to perform the surgery	Recorded at surgery visit
Surgical complications	Any complications during and after surgery	At the surgical visit
Surgical complications	Any complications during and after surgery	At time of surgical follow up visit (visit window of 7-14 days after surgery)
Implant stability		Duration of study (12 months of enrollment)
Use of Healing cap II	Ease of use of Healing cap II and effect on surgical dressing	At the surgical visit
Use of Healing cap II	Ease of use of Healing cap II and effect on surgical dressing	At time of surgical follow up visit (visit window of 7-14 days after surgery)
Skin healing at first follow-up visit		At time of surgical follow up visit (visit window of 7-14 days after surgery)
Pain and numbness		Duration of study (12 months of enrollment)
Time of fitting and type of sound processor		Duration of study (12 months of enrollment)

Collaborators and Investigators

• Sponsor: Oticon Medical
• Investigators: Principal Investigator: Søren Foghsgaard, M.D., Soeren.Foghsgaard@regionh.dk

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2014
• Primary Completion (Actual): October 1, 2015
• Study Completion (Actual): April 19, 2016

Study Registration Dates

• First Submitted: October 14, 2014
• First Submitted That Met QC Criteria: October 23, 2014
• First Posted (Estimate): October 24, 2014

Study Record Updates

• Last Update Posted (Actual): November 27, 2017
• Last Update Submitted That Met QC Criteria: November 23, 2017
• Last Verified: November 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Otorhinolaryngologic Diseases; Ear Diseases; Sensation Disorders; Hearing Disorders; Hearing Loss; Deafness; Hearing Loss, Conductive; Hearing Loss, Mixed Conductive-Sensorineural
• Other Study ID Numbers: C51

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO