M72.0
Conditions
Interventions
Group 1: Assessment of the air quality inside the Surgitent Extremity throughout Dupuytren surgeries by measurement of number and size of airborne particulates (particulate count per m3 in total and i
Sponsors
Surgitent GmbH
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: o Male/ Female/ Divers o Indication for surgical treatment of the above-named conditions using the SURGITENT Extremity o Written informed consent o Age =18 years
Exclusion criteria
Exclusion criteria: o Inability of the patient to consent/ lack of ability to report any side effects (e.g., presence of severe cognitive deficits) o Emergency setting o Presence of terminal disease with a life expectancy =6 months o Presence of skin disease(s) and/ or malignant lesion(s) of the skin in the anticipated extended surgical area o Malformations and/or fractures that hamper positioning of the arm before/ during surgery and thus use of the SURGITENT Extremity as intended o Intake of Vitamin K antagonists and/ or new oral anticoagulant medication, which may prolong surgery duration and/or complicate surgery execution o Contraindications to the SURGITENT Extremity according to the instructions for use (IFU) o Participation in another study o Pregnancy and lactation
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| oAssessment of the air quality inside the SURGITENT Extremity throughout upper extremity surgery a)Acquisition of number and size of airborne particulates (particulate count per m3 in total and in the size groups = 0.5µm and < 0.5µm) inside the sterile field | — |
Secondary
| Measure | Time frame |
|---|---|
| o Assessment of post-operative infection o Usability assessment of the SURGITENT Extremity (questionnaire to be answered by surgeon and/ or nurse) a) Installation of the SURGITENT b) Usability of the SURGITENT including parameters such as visibility | — |
Countries
Germany
Contacts
Public ContactDominik Steiner
BG Unfallklinik
Outcome results
None listed