Assessment of DAFILON® Suture Material for Skin Closure (SKINDA)

Aesculap

Status: Completed

Conditions: Injury Skin; Laceration of Skin

Study type: Observational

Funder types: Industry

Identifiers

NCT04617041

AAG-O-H-1909

Details and patient eligibility

About

In this non-interventional study (NIS) a polyamide non-absorbable suture (Dafilon®) will be evaluated for skin closure in adult and pediatric patients. The aim of the study is to collect clinical data on the performance of Dafilon® for skin closure. The results of this study will generate further clinical evidence for the use and the benefit of a non-absorbable surgical suture material produced from polyamide. Furthermore, the proactive collection of clinical data for Dafilon® suture will support the maintenance of the suture material on the market, so that in the future other patients can receive the suture material for skin closure.

Enrollment: 115 patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion:

• Written informed consent is available
• Patients undergoing skin closure with Dafilon®
• Small linear minimally contaminated incision/laceration in the trunk or extremities

Exclusion:

• Emergency surgery
• Pregnancy
• Facial lacerations or incisions
• Visible dirt in the wounds
• Nonlinear shape
• Patient taking medication that might affect wound healing
• Patient with hypersensitivity or allergy to the suture material