Status:
COMPLETED
Performance of Safety of SILKAM® Suture Material in Oral Surgery
Lead Sponsor:
Aesculap AG
Collaborating Sponsors:
B.Braun Surgical SA
Conditions:
Tooth, Impacted
Teeth Impact
Eligibility:
All Genders
18+ years
Brief Summary
Assessment of SILKAM® suture material in mucosal closure in oral surgery (mucosal sutures). A prospective, monocentric, single arm observational study.
Detailed Description
The aim of this Non Interventional Study is to collect systematically and proactively different clinical parameters regarding safety, effectiveness, and performance of SILKAM® suture material under th...
Eligibility Criteria
Inclusion
- Patients undergoing mucosal wound closure using SILKAM® as suture material in oral surgery (in the event that more than one incision is performed in the same patient, only one incision will be considered).
Exclusion
- Patients taking medication that might affect wound healing
- Patients having a condition that might affect wound healing.
- Patients with hypersensitivity or allergy to the suture material.
- Participation in another (Randomized) Clinical Trial / Clinical Study.
- Non-compliance of patient (i.e. dementia).
Key Trial Info
Start Date :
September 21 2022
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
November 16 2023
Estimated Enrollment :
105 Patients enrolled
Trial Details
Trial ID
NCT05296902
Start Date
September 21 2022
End Date
November 16 2023
Last Update
February 20 2024
Active Locations (1)
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1
Facultat D'odontologia. Universitat Internacional de Catalunya
Sant Cugat del Vallès, Catalonia, Spain, 08195