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

NCT ID: NCT03792737

Last Updated: 2022-04-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 501 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-04-01
• Study Completion Date: 2020-01-06

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.

Conditions

Sutures

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: EXPERIMENTAL

Spiral PDS Plus

Intervention Type: DEVICE

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.

MONOCRYL Plus

Intervention Type: DEVICE

MONOCRYL Plus is a non-barbed antibacterial monofilament, synthetic absorbable suture. The suture contains triclosan, a broad spectrum antibacterial agent.

VICRYL Plus

Intervention Type: DEVICE

VICRYL Plus antibacterial suture is a non-barbed synthetic absorbable sterile, surgical suture. The suture contains triclosan, a broad spectrum antibacterial agent.

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.

Group Type: EXPERIMENTAL

Spiral MONOCRYL Plus

Intervention Type: DEVICE

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.

PDS Plus

Intervention Type: DEVICE

PDS Plus is a non-barbed antibacterial monofilament, synthetic absorbable suture. The suture contains triclosan, a broad spectrum antibacterial agent.

VICRYL Plus

Intervention Type: DEVICE

VICRYL Plus antibacterial suture is a non-barbed synthetic absorbable sterile, surgical suture. The suture contains triclosan, a broad spectrum antibacterial agent.

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.

Group Type: ACTIVE_COMPARATOR

PDS Plus

Intervention Type: DEVICE

PDS Plus is a non-barbed antibacterial monofilament, synthetic absorbable suture. The suture contains triclosan, a broad spectrum antibacterial agent.

MONOCRYL Plus

Intervention Type: DEVICE

MONOCRYL Plus is a non-barbed antibacterial monofilament, synthetic absorbable suture. The suture contains triclosan, a broad spectrum antibacterial agent.

VICRYL Plus

Intervention Type: DEVICE

VICRYL Plus antibacterial suture is a non-barbed synthetic absorbable sterile, surgical suture. The suture contains triclosan, a broad spectrum antibacterial agent.

Interventions

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.

Intervention Type: 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.

Intervention Type: DEVICE

PDS Plus

PDS Plus is a non-barbed antibacterial monofilament, synthetic absorbable suture. The suture contains triclosan, a broad spectrum antibacterial agent.

Intervention Type: DEVICE

MONOCRYL Plus

MONOCRYL Plus is a non-barbed antibacterial monofilament, synthetic absorbable suture. The suture contains triclosan, a broad spectrum antibacterial agent.

Intervention Type: 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.

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 69 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ethicon, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Hao Zhang

Role: PRINCIPAL_INVESTIGATOR

First Hospital of China Medical University

Locations

Fujian Medical University Union Hospital

Fuzhou, Fujian, China

Peking University Shenzhen Hospital

Shenzhen, Guangdong, China

The First Affiliated Hospital of Zhengzhou University

Zhengzhou, Henan, China

Union Hospital Tongji Medical college Huazhong University of science and technologyUnion Hospital Tongji Medical college Huazhong University of science and technology

Wuhan, Hubei, China

Jiangsu Province Hospital

Nanjing, Jiangsu, China

The First Hospital of China Medical University

Shenyang, Liaoning, China

The First Affiliated Hospital of Xi'An Jiaotong University

Xi’an, Shanxi, China

West China Hospital, Sichuan University

Chengdu, Sichuan, China

The First Affiliated Hospital, Zhejiang University

Hangzhou, Zhejiang, China

Beijing Friendship Hospital, Capital Medical University

Beijing, , China

Countries

China

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

ESC-201702

Identifier Type: -

Identifier Source: org_study_id