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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
501
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.
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.
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
Wound Healing Grade
Percentage of Participants with Grade A Healing of Surgical Incision
Time frame: 5-7days
Incision Closure Time
the time required from the first needle insertion for stitching ribbon muscles to the completion of intradermal suture (minutes)
Time frame: during surgery, an average of around 12 Mins
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.
Time frame: 5-7 Days after Surgery and 28-35 Days after Surgery
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
Time frame: 28-35 days
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
Time frame: 5-7 days after surgery
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.
Time frame: 28-35 days after surgery
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PDS Plus is a non-barbed antibacterial monofilament, synthetic absorbable suture. The suture contains triclosan, a broad spectrum antibacterial agent.
MONOCRYL Plus is a non-barbed antibacterial monofilament, synthetic absorbable suture. The suture contains triclosan, a broad spectrum antibacterial agent.
VICRYL Plus antibacterial suture is a non-barbed synthetic absorbable sterile, surgical suture. The suture contains triclosan, a broad spectrum antibacterial agent.
Union Hospital Tongji Medical college Huazhong University of science and technologyUnion Hospital Tongji Medical college Huazhong University of science and technology
Wuhan, Hubei, China
Jiangsu Province Hospital
Nanjing, Jiangsu, China
The First Hospital of China Medical University
Shenyang, Liaoning, China
The First Affiliated Hospital of Xi'An Jiaotong University
Xi’an, Shanxi, China
West China Hospital, Sichuan University
Chengdu, Sichuan, China
The First Affiliated Hospital, Zhejiang University
Hangzhou, Zhejiang, China
Beijing Friendship Hospital, Capital Medical University
Beijing, China
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.
Time frame: 5-7 Days after surgery
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.
Time frame: 28-35 Days after surgery