PER-SAF_PDOS (Performance and Safety of Polydioxanone Suture)

21 Century Medical Co., Ltd.

Status: Not yet enrolling

Conditions: Wrinkles; Anti Aging; Face-lift

Treatments: Device: PDO suture

Study type: Interventional

Funder types: Industry

Identifiers

NCT07068061

PC-MD-CIP-004

Details and patient eligibility

About

This clinical investigation aims to confirm the safety and efficacy of the ID in facial soft tissue reconstruction, specifically for non-incision surgery to tighten and lift the facial skin for a rejuvenated facial appearance.

Enrollment: 50 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients over 18 years old with full legal capacity, male and female;
• Patients with ability to understand the proposed aesthetic correction and to understand and sign informed consent;
• Patients who are willing and able to comply with scheduled visits, aesthetic correction procedure and other trial procedures.

Exclusion criteria

• Pregnant or breast--feeding women;
• Patients currently participating in any other clinical investigation;
• Patients who have received a vaccine within 14 days prior to the baseline or plan to have vaccine within 14 days after the injection;
• Patients with a medical history of systemic diseases, including severe kidney, liver, heart and neurological disorders.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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50 participants in 1 patient group

Interventional arm

Experimental group

Description:

The procedure will start with skin cleansing using an antiseptic and careful marking of entry and exit points for thread placement. Aesthetic cream and local anaesthesia will be applied to enhance patient comfort before inserting PDO barbed threads into the subdermal layer using a cannula. The threads will be adjusted to create a natural-looking lift, followed by manual lifting to anchor them securely within the tissue. Finally, any excess thread will be trimmed, the area massaged for proper positioning, and the skin cleaned again to maintain sterility.

Treatment:

Device: PDO suture