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

Study Overview
=================
Brief Summary
-----------------
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.

Detailed 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.

Official Title
-----------------
A Prospective, Multi-center, Randomized Controlled Study Evaluating the Efficacy and Safety of Two Types of Absorbable Surgical Sutures in the Suturing of Thyroid Surgery Incision

Conditions
-----------------
Sutures

Intervention / Treatment
-----------------
* Device: Spiral PDS Plus
* Device: Spiral MONOCRYL Plus
* Device: PDS Plus
* Device: MONOCRYL Plus
* Device: VICRYL Plus


Participation Criteria
=================
Eligibility Criteria
-----------------
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 69 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Investigational group 1<br>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. | Device: Spiral PDS Plus<br>* The Spiral PDS Plus is an antibacterial monofilament, synthetic absorbable device. It contains triclosan, a broad spectrum antibacterial agent. The device consists of barbed suture material, armed with a surgical needle on one end and a fixation loop at the opposite end. The device is designed to anchor with a closed loop at one end and a unidirectional barbed section on the other end. Spiral PDS Plus barbs are oriented in one direction to allow tissue approximation without the need to tie surgical knots.<br>Device: MONOCRYL Plus<br>* MONOCRYL Plus is a non-barbed antibacterial monofilament, synthetic absorbable suture. The suture contains triclosan, a broad spectrum antibacterial agent.<br>Device: VICRYL Plus<br>* VICRYL Plus antibacterial suture is a non-barbed synthetic absorbable sterile, surgical suture. The suture contains triclosan, a broad spectrum antibacterial agent.<br>|
| Experimental: Investigational group 2<br>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. | Device: Spiral MONOCRYL Plus<br>* The Spiral MONOCRYL Plus is an antibacterial monofilament, synthetic absorbable device. It contains triclosan, a broad spectrum antibacterial agent. The device consists of barbed suture material, armed with a surgical needle on one end and a fixation loop at the opposite end. The device is designed to anchor with a closed loop at one end and a unidirectional barbed section on the other end. Spiral MONOCRYL Plus barbs are oriented in one direction to allow tissue approximation without the need to tie surgical knots.<br>Device: PDS Plus<br>* PDS Plus is a non-barbed antibacterial monofilament, synthetic absorbable suture. The suture contains triclosan, a broad spectrum antibacterial agent.<br>Device: VICRYL Plus<br>* VICRYL Plus antibacterial suture is a non-barbed synthetic absorbable sterile, surgical suture. The suture contains triclosan, a broad spectrum antibacterial agent.<br>|
| Active Comparator: Control group<br>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. | Device: PDS Plus<br>* PDS Plus is a non-barbed antibacterial monofilament, synthetic absorbable suture. The suture contains triclosan, a broad spectrum antibacterial agent.<br>Device: MONOCRYL Plus<br>* MONOCRYL Plus is a non-barbed antibacterial monofilament, synthetic absorbable suture. The suture contains triclosan, a broad spectrum antibacterial agent.<br>Device: VICRYL Plus<br>* VICRYL Plus antibacterial suture is a non-barbed synthetic absorbable sterile, surgical suture. The suture contains triclosan, a broad spectrum antibacterial agent.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Wound Healing Grade | Percentage of Participants with Grade A Healing of Surgical Incision | 5-7days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incision Closure Time | the time required from the first needle insertion for stitching ribbon muscles to the completion of intradermal suture (minutes) | during surgery, an average of around 12 Mins | 
| Postoperative Incisional Pain Score (Visual Analogue Scale, VAS) | For the postoperative incisional pain score, a score of 0 means no pain, and a score of 10 means unbearable: severely affects sleep with other symptoms, or passive position. | 5-7 Days after Surgery and 28-35 Days after Surgery | 
| Modified Hollander Wound Evaluation Scale - FAS | Total cosmetic score. Assessed by Central Imaging evaluators using incision pictures to evaluate healing status. range is from 0 to 5, 0 is best and 5 is worst | 28-35 days | 
| Health Related Quality of Life Scale (EQ-5D-5L) | Summary of European Quality of Life-5 Dimensions, 5 Levels Scale (EQ-5D-5L) Index Values by Follow-Up Visit - Full Analysis Set. it's to evaluate subjects Health related quality of life. rang is 0 to 1, 0 is better and 1 is worse | 5-7 days after surgery | 
| Health Related Quality of Life Scale (EQ-5D-5L) | Summary of European Quality of Life-5 Dimensions, 5 Levels Scale (EQ-5D-5L) Index Values by Follow-Up Visit - Full Analysis Set. it's to evaluate subjects Health related quality of life. rang is 0 to 1. 0 is better and 1 is worse. | 28-35 days after surgery | 
| Summary of EQ-5D VAS Score | Summary of European Quality of Life-5 Dimensions, 5 Levels Scale (EQ-5D-5L) Index Values by Follow-Up Visit - Full Analysis Set. it's to evaluate subjects Health related quality of life. rang is 0 to 100. 100 is best and 0 is worst. | 5-7 Days after surgery | 
| Summary of EQ-5D VAS Score | Summary of European Quality of Life-5 Dimensions, 5 Levels Scale (EQ-5D-5L) Index Values by Follow-Up Visit - Full Analysis Set. it's to evaluate subjects Health related quality of life. rang is 0 to 100. | 28-35 Days after surgery |