Clinical trial NCT03792737: A Study of Two Types of Absorbable Surgical Sutures in the Suturing of Thyroid Surgery Incision
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sutures
Lead sponsor: Ethicon, Inc.
Sponsor class: INDUSTRY
First posted: 2019-01-03
Enrollment: 501
Sex: ALL
Minimum age (years): 18
Maximum age (years): 69
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Wound Healing Grade
timeFrame: 5-7days
Secondary outcomes:
measure: Incision Closure Time
timeFrame: during surgery, an average of around 12 Mins
measure: Postoperative Incisional Pain Score (Visual Analogue Scale, VAS)
timeFrame: 5-7 Days after Surgery and 28-35 Days after Surgery
measure: Modified Hollander Wound Evaluation Scale - FAS
timeFrame: 28-35 days
measure: Health Related Quality of Life Scale (EQ-5D-5L)
timeFrame: 5-7 days after surgery
measure: Health Related Quality of Life Scale (EQ-5D-5L)
timeFrame: 28-35 days after surgery
measure: Summary of EQ-5D VAS Score
timeFrame: 5-7 Days after surgery
measure: Summary of EQ-5D VAS Score
timeFrame: 28-35 Days after surgery
Other outcomes:
Locations:
city: Fuzhou
country: China
facility: Fujian Medical University Union Hospital
state: Fujian
city: Shenzhen
country: China
facility: Peking University Shenzhen Hospital
state: Guangdong
city: Zhengzhou
country: China
facility: The First Affiliated Hospital of Zhengzhou University
state: Henan
city: Wuhan
country: China
facility: Union Hospital Tongji Medical college Huazhong University of science and technologyUnion Hospital Tongji Medical college Huazhong University of science and technology
state: Hubei
city: Nanjing
country: China
facility: Jiangsu Province Hospital
state: Jiangsu
city: Shenyang
country: China
facility: The First Hospital of China Medical University
state: Liaoning
city: Xi'an
country: China
facility: The First Affiliated Hospital of Xi'An Jiaotong University
state: Shanxi
city: Chengdu
country: China
facility: West China Hospital, Sichuan University
state: Sicuan Province
city: Hangzhou
country: China
facility: The First Affiliated Hospital, Zhejiang University
state: Zhejiang
city: Beijing
country: China
facility: Beijing Friendship Hospital, Capital Medical University
Study officials:
affiliation: First Hospital of China Medical University
name: Hao Zhang
role: PRINCIPAL_INVESTIGATOR
References: