Status:
COMPLETED
A Study of Two Types of Absorbable Surgical Sutures in the Suturing of Thyroid Surgery Incision
Lead Sponsor:
Ethicon, Inc.
Conditions:
Sutures
Eligibility:
All Genders
18-69 years
Phase:
NA
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 ...
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 t...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
April 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 6 2020
Estimated Enrollment :
501 Patients enrolled
Trial Details
Trial ID
NCT03792737
Start Date
April 1 2019
End Date
January 6 2020
Last Update
April 5 2022
Active Locations (10)
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1
Fujian Medical University Union Hospital
Fuzhou, Fujian, China, 350001
2
Peking University Shenzhen Hospital
Shenzhen, Guangdong, China, 518035
3
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, China, 450052
4
Union Hospital Tongji Medical college Huazhong University of science and technologyUnion Hospital Tongji Medical college Huazhong University of science and technology
Wuhan, Hubei, China, 430022