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
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 501
- 试验地点
- 10
- 主要终点
- Wound Healing Grade
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 69 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
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.
干预措施: Spiral PDS Plus (Device)
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.
干预措施: MONOCRYL Plus (Device)
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.
干预措施: VICRYL Plus (Device)
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.
干预措施: Spiral MONOCRYL Plus (Device)
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.
干预措施: PDS Plus (Device)
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.
干预措施: VICRYL Plus (Device)
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.
干预措施: PDS Plus (Device)
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.
干预措施: MONOCRYL Plus (Device)
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.
干预措施: VICRYL Plus (Device)
结局指标
主要结局
Wound Healing Grade
时间窗: 5-7days
Percentage of Participants with Grade A Healing of Surgical Incision
次要结局
- Postoperative Incisional Pain Score (Visual Analogue Scale, VAS)(5-7 Days after Surgery and 28-35 Days after Surgery)
- Health Related Quality of Life Scale (EQ-5D-5L)(28-35 days after surgery)
- Incision Closure Time(during surgery, an average of around 12 Mins)
- Modified Hollander Wound Evaluation Scale - FAS(28-35 days)
- Summary of EQ-5D VAS Score(28-35 Days after surgery)
- Health Related Quality of Life Scale (EQ-5D-5L)(5-7 days after surgery)
- Summary of EQ-5D VAS Score(5-7 Days after surgery)