A Study of Two Types of Absorbable Surgical Sutures in the Suturing of Thyroid Surgery Incision
- Conditions
- Sutures
- Interventions
- Device: Spiral PDS PlusDevice: Spiral MONOCRYL PlusDevice: PDS PlusDevice: MONOCRYL PlusDevice: VICRYL Plus
- Registration Number
- NCT03792737
- Lead Sponsor
- Ethicon, Inc.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 501
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Investigational group 2 PDS Plus 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. Control group MONOCRYL Plus 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. Investigational group 1 VICRYL Plus 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. Control group VICRYL Plus 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. Investigational group 1 Spiral PDS Plus 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. Investigational group 2 VICRYL Plus 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. Investigational group 1 MONOCRYL Plus 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. Investigational group 2 Spiral MONOCRYL Plus 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. Control group PDS Plus 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.
- Primary Outcome Measures
Name Time Method Wound Healing Grade 5-7days Percentage of Participants with Grade A Healing of Surgical Incision
- Secondary Outcome Measures
Name Time Method Postoperative Incisional Pain Score (Visual Analogue Scale, VAS) 5-7 Days after Surgery and 28-35 Days after Surgery 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.
Incision Closure Time during surgery, an average of around 12 Mins the time required from the first needle insertion for stitching ribbon muscles to the completion of intradermal suture (minutes)
Modified Hollander Wound Evaluation Scale - FAS 28-35 days 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
Summary of EQ-5D VAS Score 28-35 Days after surgery 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.
Health Related Quality of Life Scale (EQ-5D-5L) 28-35 days after surgery 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.
Trial Locations
- Locations (10)
West China Hospital, Sichuan University
🇨🇳Chengdu, Sicuan Province, China
Beijing Friendship Hospital, Capital Medical University
🇨🇳Beijing, China
The First Affiliated Hospital, Zhejiang University
🇨🇳Hangzhou, Zhejiang, China
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
Jiangsu Province Hospital
🇨🇳Nanjing, Jiangsu, 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 Hospital of China Medical University
🇨🇳Shenyang, Liaoning, China
The First Affiliated Hospital of Xi'An Jiaotong University
🇨🇳Xi'an, Shanxi, China