Clinical Survey of Oticon Medical Healing Cap
C51 - Clinical Survey of Oticon Medical Healing Cap
1 other identifier
interventional
32
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jul 2014
Typical duration for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2014
CompletedFirst Submitted
Initial submission to the registry
October 14, 2014
CompletedFirst Posted
Study publicly available on registry
October 24, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
April 19, 2016
CompletedNovember 27, 2017
November 1, 2017
1.3 years
October 14, 2014
November 23, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
Fitting of sound processor at surgical follow-up visit
At time of surgical follow up visit (visit window of 7-14 days after surgery)
Other Outcomes (9)
Surgical time
Recorded at surgery visit
Surgical complications
At the surgical visit
Surgical complications
At time of surgical follow up visit (visit window of 7-14 days after surgery)
- +6 more other outcomes
Study Arms (1)
Use of Healing cap II
EXPERIMENTALSingle arm study using a new healing cap as intervention
Interventions
Healing cap II is used instead of the traditional healing cap as part of the surgical dressing after bone anchored hearing aid implant surgery
Eligibility Criteria
You may qualify if:
- Patients eligible for treatment with a bone anchored hearing aid
- years or older
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Oticon Medicallead
Study Sites (2)
Dept. of Otolaryngology - Head & Neck Surgery and Audiology, Gentofte/Rigshospitalet
Gentofte Municipality, Hellerup, 2900, Denmark
Department of Oto-Rhino-Laryngology & Audiology, Aalborg University Hospital
Aalborg, 9000, Denmark
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Søren Foghsgaard, M.D.
Soeren.Foghsgaard@regionh.dk
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 14, 2014
First Posted
October 24, 2014
Study Start
July 1, 2014
Primary Completion
October 1, 2015
Study Completion
April 19, 2016
Last Updated
November 27, 2017
Record last verified: 2017-11
Data Sharing
- IPD Sharing
- Will not share