NCT05225714

Dermal Wound Closure Using Silkam®

Assessment of Performance of Silkam® Suture Material for Skin Closure - a Prospective, Single Center, Single Arm, Observational Study in Daily Practice

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 161 (actual)
• Sponsor: Aesculap AG · Industry
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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 closure under clinical routine. Safety and effectiveness parameters commonly used in skin closure are to be used to evaluate the performance of the suture material. 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 the daily routine clinical practice when used for skin closure as intended.

Conditions

• Contusions
• Incision
• Laceration

Timeline

• Start date: 2022-07-21
• Primary completion: 2025-06-25
• Completion: 2025-06-25
• First posted: 2022-02-04
• Last updated: 2026-04-17

Locations

1 site across 1 country: Spain