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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Facultat D'odontologia. Universitat Internacional de Catalunya

Sant Cugat del Vallès, Catalonia, Spain, 08195