Optilene® Suture Material for Dermal Sutures (OPTIDERMAL)

Aesculap

Status: Completed

Conditions: Incision; Laceration

Study type: Observational

Funder types: Industry

Identifiers

NCT05240248

AAG-O-H-1928

Details and patient eligibility

About

In this non-interventional study, Optilene® suture will be evaluated for skin closure in adult patients.

Full description

The study is designed as a prospective, unicentric and single-arm observational study to evaluate Optilene® suture material for skin closure.

The product under investigation will be used in routine clinical practice and according to the Instructions for Use (IFU). After operation the investigator will examine the patients at discharge, at 10±5 days after surgery (removal of the suture) and 30±10 days postoperatively.

Enrollment: 172 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Adult patients undergoing skin closure using Optilene® suture material.
• Small (0.5 cm - 10 cm) linear minimally contaminated incision/laceration in the trunk, neck or extremities (in the event that more than one incision is performed in the same patient, only one incision will be included).
• Written informed consent.

Exclusion criteria

• Emergency surgery.
• Transplant surgery.
• Pregnancy.
• Facial laceration or incision.
• Visible dirt in the wound.
• Non-linear shape.
• Patient with limb ischemia.
• Patient taking medication that might affect wound healing (i.e. cytotoxic antineoplastic and immunosuppressive agents, corticosteroids, nonsteroidal anti-inflammatory drugs (NSAIDs), anticoagulants).
• Patient with hypersensitivity or allergy to the suture material.