Status:
COMPLETED
Assessment of DAFILON® Suture Material in Oral Surgery (Mucosal Sutures)
Lead Sponsor:
Aesculap AG
Collaborating Sponsors:
B.Braun Surgical SA
Conditions:
Oral Surgery
Tooth Extraction
Eligibility:
All Genders
18+ years
Brief Summary
In this non-interventional study (NIS) a polyamide non-absorbable suture (Dafilon) will be evaluated for oral surgery (mucosal closure after e.g. wisdom teeth extraction, implant surgery, etc.) in adu...
Detailed Description
In this non-interventional study (NIS) a polyamide non-absorbable suture (Dafilon) will be evaluated for oral surgery (mucosal closure after e.g. wisdom teeth extraction, implant surgery, etc.) in adu...
Eligibility Criteria
Inclusion
- Adult patients undergoing mucosal wound closure using Dafilon 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 included).
- Written informed consent regarding the data collection for the PMCF.
Exclusion
- Emergency surgery.
- Oral surgery procedures requiring bone regeneration.
- Pregnancy.
- Patients taking medication that might affect wound healing.
- Patients with hypersensitivity or allergy to the suture material.
Key Trial Info
Start Date :
July 6 2020
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
April 14 2021
Estimated Enrollment :
105 Patients enrolled
Trial Details
Trial ID
NCT04390620
Start Date
July 6 2020
End Date
April 14 2021
Last Update
December 22 2021
Active Locations (2)
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1
Praxisklinik für Mund-, Kiefer- und Gesichtschirurgie, Ästhetische und Plastische Chirurgie
Esslingen am Neckar, Germany, 73728
2
Universitat Internacional de Catalunya (UIC)
Barcelona, Spain