A Study of Two Types of Absorbable Surgical Sutures in the Suturing of Thyroid Surgery Incision

This study adopts a multicenter, prospective, randomized controlled design. The study population are subjects who undergo thyroid surgery.

Before the surgery, subjects are randomized in 1:1:1 ratio to the investigational group 1 (using Spiral PDS Plus), investigational group 2 (using Spiral MONOCRYL Plus) and control group. See the table below for the specific suture levels, materials and techniques of each group.

A blinded central imaging evaluation will be performed on the healing condition of surgical incision on Day 5-7 post-surgery. The subjects will be blinded to the type of suture used for wound closure.

Inclusion criteria

• The subject is ≥18, and <70 years old
• Planned open thyroid surgery, adopting an anterior cervical curved incision (Kocher's incision);
• Subject who volunteers to participate in this study, follows the study requirements and follow-up visit and signs the written Informed Consent Form voluntarily;
• Subject who agrees to not schedule any elective surgical operation except the study surgery before the study is completed;
• The investigator considers the subject's expected postoperative survival time is not less than 3 months.

Exclusion criteria

• Female subjects who are pregnant or lactation at screening;
• Preoperative clinical staging shows stage IV thyroid cancer, or cervical lymph nodes dissection is planned;
• Suspected or confirmed anaplastic thyroid cancer;
• Peripheral vascular disease affecting blood supply of the neck;
• Active infectious collagenosis (e.g. scleroderma), or any other disease that would interfere with wound healing;
• Fasting plasma glucose ≥7.7 mmol/L;
• History of coagulation diseases;
• Current oral or intravenous antibiotic therapy for existing disease or infection;
• History of immunosuppressant use (e.g. steroids) within the last 6 months;
• Chemotherapy or radiotherapy within the last 6 months, or planned chemotherapy or radiotherapy during the study;
• Personal or family history of keloid formation or hyperplasia;
• Current participation in any other drug (within 30 days or within 5 half-lives of the investigational drug) or device clinical study;
• History of any thyroid surgery, except thyroid fine-needle aspiration biopsy;
• Planned use of skin adhesive at the incision site;
• The subject is not suitable for participating in this study for any other reasons, as judged by the investigator.