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

NCT03792737 | Completed Results

• 1 other identifier: ESC-201702
• Study Type: interventional
• Target: 501
• Locations: 1 country
• Sites: 10

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.

Conditions

Sutures

Outcome Measures

Primary Outcomes (1)

• Wound Healing Grade

  Percentage of Participants with Grade A Healing of Surgical Incision

  5-7days

Secondary Outcomes (7)

• Incision Closure Time

  during surgery, an average of around 12 Mins

• Postoperative Incisional Pain Score (Visual Analogue Scale, VAS)

  5-7 Days after Surgery and 28-35 Days after Surgery

• Modified Hollander Wound Evaluation Scale - FAS

  28-35 days

• Health Related Quality of Life Scale (EQ-5D-5L)

  5-7 days after surgery

• Health Related Quality of Life Scale (EQ-5D-5L)

  28-35 days after surgery

Study Arms (3)

Investigational group 1

EXPERIMENTAL

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; Device: MONOCRYL Plus; Device: VICRYL Plus

Investigational group 2

EXPERIMENTAL

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; Device: PDS Plus; Device: VICRYL Plus

Control group

ACTIVE COMPARATOR

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; Device: MONOCRYL Plus; Device: VICRYL Plus

Interventions

Spiral PDS Plus 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.

Investigational group 1

Spiral MONOCRYL Plus 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.

Investigational group 2

PDS Plus DEVICE

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

Control group; Investigational group 2

MONOCRYL Plus DEVICE

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

Control group; Investigational group 1

VICRYL Plus 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; Investigational group 1; Investigational group 2

Eligibility Criteria

• Age: 18 Years - 69 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ethicon, Inc.: lead

Study Sites (10)

Fujian Medical University Union Hospital

Fuzhou, Fujian, 350001, China

Location

Peking University Shenzhen Hospital

Shenzhen, Guangdong, 518035, China

Location

The First Affiliated Hospital of Zhengzhou University

Zhengzhou, Henan, 450052, China

Location

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

Wuhan, Hubei, 430022, China

Location

Jiangsu Province Hospital

Nanjing, Jiangsu, 210029, China

Location

The First Hospital of China Medical University

Shenyang, Liaoning, 110001, China

Location

The First Affiliated Hospital of Xi'An Jiaotong University

Xi’an, Shanxi, 710061, China

Location

West China Hospital, Sichuan University

Chengdu, Sichuan, 610041, China

Location

The First Affiliated Hospital, Zhejiang University

Hangzhou, Zhejiang, 310006, China

Location

Beijing Friendship Hospital, Capital Medical University

Beijing, 100050, China

Location

Results Point of Contact

• Title: Xiaolei, Wang
• Organization: Johnson & Johnson Medical Shanghai Ltd.

xwang183@its.jnj.com

+86 21 33378749

Study Officials

• Hao Zhang

  First Hospital of China Medical University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 29, 2018
• First Posted: January 3, 2019
• Study Start: April 1, 2019
• Primary Completion: December 12, 2019
• Study Completion: January 6, 2020
• Last Updated: April 5, 2022
• Results First Posted: January 29, 2021

Record last verified: 2022-02

Locations

CN (10)