Nasal Septum Perforation Treatment Using Tissue Engineered Cartilage Graft
Switzerland5 participantsStarted 2021-04-09
Plain-language summary
The purpose of this study is to investigate the safety and feasibility of implanting an engineered cartilage tissue in an interposition graft with a temporoparietal fascia (TPF) flap to repair medium size septal perforation. The engineered cartilage graft is obtained by culturing expanded autologous nasal chondrocytes within a collagen type I/III membrane. In addition, first data on efficacy will be collected.
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
* • Nasal septal perforation of a medium size (diameter 0.5 to 2.0 cm), measured by endoscopy
* Age above or equal to 18 years
* Informed Consent as documented by signature
* Patient is willing and able to give written informed consent to participate in the study and to comply with all study requirements, including attending all follow-up visits and assessments
Exclusion Criteria:
* • Nasal septal perforation of a small (\<0.5 cm) or large size (\>2.0 cm)
* Patient is smoking
* Known or suspected non-compliance, drug (especially cocaine) or alcohol abuse
* Evidence of infection with HIV or hepatitis B or C, syphilis. Patients with a cured hepatitis B or C infection and/or verified antibodies are not excluded.
* Known allergies to porcine collagen, penicillin or streptomycin
* Women who are pregnant or breast feeding
* Intention to become pregnant during the course of the study
* Chronic treatment with steroids or immunomodulatory drugs
* Diabetes
* Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc. of the participant
* Patient is the investigator or any sub-investigator, research assistant, pharmacist, study coordinator, other staff or relative thereof directly involved in the conduct of the protocol or in a dependency or employment with the sponsor.
* Patient is unable to understand the patient information
* Patient has a known systemic connective tissu…