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

Sutures Clinical Trial

— Nautilus  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03792737
• Other study ID #: ESC-201702
• Status: Completed
• Phase: N/A
• Start date: April 1, 2019
• Est. completion date: January 6, 2020

Study information

• Verified date: February 2022
• Source: Ethicon, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 501
• Est. completion date: January 6, 2020
• Est. primary completion date: December 12, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 69 Years

Eligibility

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.

Related Conditions & MeSH terms

• Surgical Wound
• Sutures

Intervention

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

Locations

Country	Name	City	State
China	Beijing Friendship Hospital, Capital Medical University	Beijing
China	West China Hospital, Sichuan University	Chengdu	Sicuan Province
China	Fujian Medical University Union Hospital	Fuzhou	Fujian
China	The First Affiliated Hospital, Zhejiang University	Hangzhou	Zhejiang
China	Jiangsu Province Hospital	Nanjing	Jiangsu
China	The First Hospital of China Medical University	Shenyang	Liaoning
China	Peking University Shenzhen Hospital	Shenzhen	Guangdong
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	The First Affiliated Hospital of Xi'An Jiaotong University	Xi'an	Shanxi
China	The First Affiliated Hospital of Zhengzhou University	Zhengzhou	Henan

Sponsors (1)

Lead Sponsor	Collaborator
Ethicon, Inc.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Wound Healing Grade	Percentage of Participants with Grade A Healing of Surgical Incision	5-7days
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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