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

Ethicon

Status: Completed

Conditions: Sutures

Treatments: Device: Spiral PDS Plus; Device: Spiral MONOCRYL Plus; Device: MONOCRYL Plus; Device: PDS Plus; Device: VICRYL Plus

Study type: Interventional

Funder types: Industry

Identifiers

NCT03792737

ESC-201702

Details and patient eligibility

About

The primary objective of this study is to evaluate the efficacy and safety of two types of absorbable surgical sutures -- STRATAFIX Spiral PDS Knotless Plus Tissue Control Device and STRATAFIX Spiral MONOCRYL Plus Knotless Tissue Control Device (hereinafter referred to as Spiral PDS Plus and Spiral MONOCRYL Plus) used in thyroid surgery to suture surgical incision.

Full description

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.

Enrollment: 501 patients

Sex: All

Ages: 18 to 69 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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501 participants in 3 patient groups

Investigational group 1

Experimental group

Description:

Investigational group 1: Use the study device Spiral PDS Plus for continuous suture of the ribbon muscles, VICRYL Plus for interrupted suture of the platysma, and MONOCRYL Plus for continuous subcuticular suture.

Treatment:

Device: MONOCRYL Plus

Device: Spiral PDS Plus

Device: VICRYL Plus

Investigational group 2

Experimental group

Description:

Investigational group 2: Use PDS Plus for continuous suture of the ribbon muscles, VICRYL Plus for interrupted suture of the platysma, and the study device Spiral MONOCRYL Plus for continuous subcuticular suture.

Treatment:

Device: Spiral MONOCRYL Plus

Device: PDS Plus

Device: VICRYL Plus

Control group

Active Comparator group

Description:

Control group: Use the control device PDS Plus for continuous suture of the ribbon muscles, VICRYL Plus for interrupted suture of the platysma, and the control device MONOCRYL Plus continuous subcuticular suture.

Treatment:

Device: MONOCRYL Plus

Device: PDS Plus

Device: VICRYL Plus