Clinical trial NCT02274129: Clinical Survey of Oticon Medical Healing Cap
Official title: C51 - Clinical Survey of Oticon Medical Healing Cap
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Conductive Hearing Loss
Mixed Hearing Loss
Unilateral Partial Deafness
Lead sponsor: Oticon Medical
Sponsor class: INDUSTRY
First posted: 2014-10-24
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Skin reactions according to Holgers
timeFrame: At time of sugical follow up visit (visit window of 7-14 days after surgery)
Secondary outcomes:
measure: Fitting of sound processor at surgical follow-up visit
timeFrame: At time of surgical follow up visit (visit window of 7-14 days after surgery)
Other outcomes:
measure: Surgical time
timeFrame: Recorded at surgery visit
measure: Surgical complications
timeFrame: At the surgical visit
measure: Surgical complications
timeFrame: At time of surgical follow up visit (visit window of 7-14 days after surgery)
measure: Implant stability
timeFrame: Duration of study (12 months of enrollment)
measure: Use of Healing cap II
timeFrame: At the surgical visit
measure: Use of Healing cap II
timeFrame: At time of surgical follow up visit (visit window of 7-14 days after surgery)
measure: Skin healing at first follow-up visit
timeFrame: At time of surgical follow up visit (visit window of 7-14 days after surgery)
measure: Pain and numbness
timeFrame: Duration of study (12 months of enrollment)
measure: Time of fitting and type of sound processor
timeFrame: Duration of study (12 months of enrollment)
Locations:
city: Gentofte
country: Denmark
facility: Dept. of Otolaryngology - Head & Neck Surgery and Audiology, Gentofte/Rigshospitalet
state: Hellerup
city: Aalborg
country: Denmark
facility: Department of Oto-Rhino-Laryngology & Audiology, Aalborg University Hospital
Study officials:
affiliation: Soeren.Foghsgaard@regionh.dk
name: Søren Foghsgaard, M.D.
role: PRINCIPAL_INVESTIGATOR
References: