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

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

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.

Study Overview

• Status: Completed
• Conditions: Sutures
• Intervention / Treatment: Device: Spiral PDS Plus; Device: MONOCRYL Plus; Device: VICRYL Plus; Device: Spiral MONOCRYL Plus; Device: PDS Plus

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.

• Study Type: Interventional
• Enrollment (Actual): 501
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Beijing, China, 100050
    • Beijing Friendship Hospital, Capital Medical University
  • Fujian
    • Fuzhou, Fujian, China, 350001
      • Fujian Medical University Union Hospital
  • Guangdong
    • Shenzhen, Guangdong, China, 518035
      • Peking University Shenzhen Hospital
  • Henan
    • Zhengzhou, Henan, China, 450052
      • The First Affiliated hospital of Zhengzhou University
  • Hubei
    • Wuhan, Hubei, China, 430022
      • Union Hospital Tongji Medical college Huazhong University of science and technologyUnion Hospital Tongji Medical college Huazhong University of science and technology
  • Jiangsu
    • Nanjing, Jiangsu, China, 210029
      • Jiangsu Province Hospital
  • Liaoning
    • Shenyang, Liaoning, China, 110001
      • The First Hospital of China Medical University
  • Shanxi
    • Xi'an, Shanxi, China, 710061
      • The First Affiliated Hospital of Xi'an Jiaotong University
  • Sicuan Province
    • Chengdu, Sicuan Province, China, 610041
      • West China Hospital, Sichuan University
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310006
      • The First Affiliated Hospital, Zhejiang University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 69 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Investigational group 1; 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; 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.; Device: MONOCRYL Plus; MONOCRYL Plus is a non-barbed antibacterial monofilament, synthetic absorbable suture. The suture contains triclosan, a broad spectrum antibacterial agent.; Device: VICRYL Plus; VICRYL Plus antibacterial suture is a non-barbed synthetic absorbable sterile, surgical suture. The suture contains triclosan, a broad spectrum antibacterial agent.
Experimental: Investigational group 2; 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: VICRYL Plus; VICRYL Plus antibacterial suture is a non-barbed synthetic absorbable sterile, surgical suture. The suture contains triclosan, a broad spectrum antibacterial agent.; Device: Spiral MONOCRYL Plus; 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.; Device: PDS Plus; PDS Plus is a non-barbed antibacterial monofilament, synthetic absorbable suture. The suture contains triclosan, a broad spectrum antibacterial agent.
Active Comparator: Control group; 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: MONOCRYL Plus; MONOCRYL Plus is a non-barbed antibacterial monofilament, synthetic absorbable suture. The suture contains triclosan, a broad spectrum antibacterial agent.; Device: VICRYL Plus; VICRYL Plus antibacterial suture is a non-barbed synthetic absorbable sterile, surgical suture. The suture contains triclosan, a broad spectrum antibacterial agent.; Device: PDS Plus; PDS Plus is a non-barbed antibacterial monofilament, synthetic absorbable suture. The suture contains triclosan, a broad spectrum antibacterial agent.

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

Collaborators and Investigators

• Sponsor: Ethicon, Inc.
• Investigators: Principal Investigator: Hao Zhang, First Hospital of China Medical University

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2019
• Primary Completion (Actual): December 12, 2019
• Study Completion (Actual): January 6, 2020

Study Registration Dates

• First Submitted: November 29, 2018
• First Submitted That Met QC Criteria: January 2, 2019
• First Posted (Actual): January 3, 2019

Study Record Updates

• Last Update Posted (Actual): April 5, 2022
• Last Update Submitted That Met QC Criteria: February 1, 2022
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: ESC-201702

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No