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NCT Number: NCT02274129

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.

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Key information

Conditions

Conductive Hearing Loss Ear Diseases Hearing Disorders Hearing Loss Hearing Loss, Conductive Hearing Loss, Mixed Conductive-Sensorineural Mixed Hearing Loss Nervous System Diseases Neurologic Manifestations Otorhinolaryngologic Diseases Pathological Conditions, Signs and Symptoms Sensation Disorders Signs and Symptoms Unilateral Partial Deafness

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Dept. of Otolaryngology - Head & Neck Surgery and Audiology, Gentofte/Rigshospitalet, Gentofte Municipality, Hellerup, Denmark

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Healing cap II

Device

Healing cap II is used instead of the traditional healing cap as part of the surgical dressing after bone anchored hearing aid implant surgery

Primary outcomes

  1. Skin reactions according to Holgers

    Time frame: At time of sugical follow up visit (visit window of 7-14 days after surgery)

    Focus is on healing, post-operative complications and skin reactions after the first 7-14 days after surgery.

Secondary outcomes

  1. Fitting of sound processor at surgical follow-up visit

    Time frame: At time of surgical follow up visit (visit window of 7-14 days after surgery)

    Implant stability is monitored before and after sound processor fitting through ISQ and clinical assessments.

Other outcomes

  1. Surgical time

    Time frame: Recorded at surgery visit

    Time taken to perform the surgery

  2. Surgical complications

    Time frame: At the surgical visit

    Any complications during and after surgery

  3. Surgical complications

    Time frame: At time of surgical follow up visit (visit window of 7-14 days after surgery)

    Any complications during and after surgery

  4. Implant stability

    Time frame: Duration of study (12 months of enrollment)

  5. Use of Healing cap II

    Time frame: At the surgical visit

    Ease of use of Healing cap II and effect on surgical dressing

  6. Use of Healing cap II

    Time frame: At time of surgical follow up visit (visit window of 7-14 days after surgery)

    Ease of use of Healing cap II and effect on surgical dressing

  7. Skin healing at first follow-up visit

    Time frame: At time of surgical follow up visit (visit window of 7-14 days after surgery)

  8. Pain and numbness

    Time frame: Duration of study (12 months of enrollment)

  9. Time of fitting and type of sound processor

    Time frame: Duration of study (12 months of enrollment)

Sponsors and collaborators

Lead sponsor

Oticon Medical

Industry

Registry information

Official study title

C51 - Clinical Survey of Oticon Medical Healing Cap

Important dates

Study start
2014
Primary completion
2015
Study completion
2016
First posted
Oct 24, 2014
Registry last updated
Nov 27, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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