Dermal Wound Closure Using Silkam® (DERMASILK)

Aesculap

Status: Enrolling

Conditions: Contusions; Incision; Laceration

Study type: Observational

Funder types: Industry

Identifiers

NCT05225714

AAG-O-H-1929

Details and patient eligibility

About

Assessment of performance of Silkam® suture material for skin closure. A prospective, single center, single arm, observational study in daily practice.

Full 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.

Enrollment: 164 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

• Adult and paediatric patients undergoing skin closure using Silkam® as suture material.
• Written informed consent regarding the data collection for the PMCF study.

Exclusion criteria

• Pregnancy
• Visible dirty wounds
• Patients taking medication that might affect wound healing
• Patients with hypersensitivity or allergy to the suture material