Status:
RECRUITING
Dermal Wound Closure Using Silkam®
Lead Sponsor:
Aesculap AG
Collaborating Sponsors:
B.Braun Surgical SA
Conditions:
Contusions
Incision
Eligibility:
All Genders
Brief Summary
Assessment of performance of Silkam® suture material for skin closure. A prospective, single center, single arm, observational study in daily practice.
Detailed Description
The prospective, monocentric, single-arm, observational Post Market Clinical Follow-Up (PMCF) study is done to continue to evaluate the safety and performance of Silkam® suture material for skin closu...
Eligibility Criteria
Inclusion
- Adult and paediatric patients undergoing skin closure using Silkam® as suture material.
- Written informed consent regarding the data collection for the PMCF study.
Exclusion
- Pregnancy
- Visible dirty wounds
- Patients taking medication that might affect wound healing
- Patients with hypersensitivity or allergy to the suture material
Key Trial Info
Start Date :
July 21 2022
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 1 2026
Estimated Enrollment :
164 Patients enrolled
Trial Details
Trial ID
NCT05225714
Start Date
July 21 2022
End Date
December 1 2026
Last Update
November 17 2025
Active Locations (1)
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1
Hospital Universitari Germans Trias i Pujol
Badalona, Spain, 08916