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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Investigational group 1 | Experimental | 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. |
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| Investigational group 2 | Experimental | 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. |
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| Control group | Active Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Spiral PDS Plus | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Wound Healing Grade | Percentage of Participants with Grade A Healing of Surgical Incision | 5-7days |
| Measure | Description | Time Frame |
|---|---|---|
| Incision Closure Time | the time required from the first needle insertion for stitching ribbon muscles to the completion of intradermal suture (minutes) | during surgery, an average of around 12 Mins |
| Postoperative Incisional Pain Score (Visual Analogue Scale, VAS) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Hao Zhang | First Hospital of China Medical University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fujian Medical University Union Hospital | Fuzhou | Fujian | 350001 | China | ||
| Peking University Shenzhen Hospital |
one subject didn't participate screen visit and randomize, but receive IP(group 2) treatment by mistake. investigator collect his safety information. so in protocol enrollment plan is 501 subjects, but actually received screen and randomization is 500 patients.
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| ID | Title | Description |
|---|---|---|
| FG000 | Investigational Group 1 | Spiral PDS Plus |
| FG001 | Investigational Group 2 | Spiral MONOCRYL Plus |
| FG002 | Control groupEdit | PDS Plus or Monocryl Plus |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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Full Analysis Population(FAS): FAS consists of all the enrolled subjects who were randomized and at least post-baseline effectiveness endpoint evaluation.
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| ID | Title | Description |
|---|---|---|
| BG000 | Investigational Group 1 | Spiral PDS Plus |
| BG001 | Investigational Group 2 | Spiral MONOCRYL Plus |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Wound Healing Grade | Percentage of Participants with Grade A Healing of Surgical Incision | Posted | Number | 95% Confidence Interval | percentage | 5-7days |
|
35 days
AE is an untoward medical occurrence during the clinical study and which does not necessarily have a causal relationship with the study medical device.
one subject didn't participate screen visit and randomize, but receive IP(group 2) treatment by mistake. investigator collect his safety information. so the Number of Participants at Risk of group 2 is one more than other rows.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Investigational Group 1 | Spiral PDS Plus | 0 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Papillary thyroid cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | study protocol | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Productive cough | Respiratory, thoracic and mediastinal disorders | study protocol | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Xiaolei, Wang | Johnson & Johnson Medical Shanghai Ltd. | +86 21 33378749 | xwang183@its.jnj.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Sep 30, 2019 | Feb 1, 2022 | Prot_002.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jul 23, 2020 | Dec 11, 2020 | SAP_000.pdf |
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|
| Spiral MONOCRYL Plus | Device | 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. |
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| PDS Plus | Device | PDS Plus is a non-barbed antibacterial monofilament, synthetic absorbable suture. The suture contains triclosan, a broad spectrum antibacterial agent. |
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| MONOCRYL Plus | Device | MONOCRYL Plus is a non-barbed antibacterial monofilament, synthetic absorbable suture. The suture contains triclosan, a broad spectrum antibacterial agent. |
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| VICRYL Plus | Device | VICRYL Plus antibacterial suture is a non-barbed synthetic absorbable sterile, surgical suture. The suture contains triclosan, a broad spectrum antibacterial agent. |
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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. |
| 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 | 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 | 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. | 28-35 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. 100 is best and 0 is worst. | 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. | 28-35 Days after surgery |
| Shenzhen |
| Guangdong |
| 518035 |
| China |
| The First Affiliated Hospital of Zhengzhou University | Zhengzhou | Henan | 450052 | China |
| Union Hospital Tongji Medical college Huazhong University of science and technologyUnion Hospital Tongji Medical college Huazhong University of science and technology | Wuhan | Hubei | 430022 | China |
| Jiangsu Province Hospital | Nanjing | Jiangsu | 210029 | China |
| The First Hospital of China Medical University | Shenyang | Liaoning | 110001 | China |
| The First Affiliated Hospital of Xi'An Jiaotong University | Xi’an | Shanxi | 710061 | China |
| West China Hospital, Sichuan University | Chengdu | Sichuan | 610041 | China |
| The First Affiliated Hospital, Zhejiang University | Hangzhou | Zhejiang | 310006 | China |
| Beijing Friendship Hospital, Capital Medical University | Beijing | 100050 | China |
| BG002 |
| Control groupEdit |
PDS Plus or Monocryl Plus |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Number | Participants |
|
| Units | Counts |
|---|---|
| Participants |
|
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| Secondary | Incision Closure Time | the time required from the first needle insertion for stitching ribbon muscles to the completion of intradermal suture (minutes) | Posted | Mean | Standard Deviation | minutes | during surgery, an average of around 12 Mins |
|
|
|
| Secondary | 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. | Full Analysis Set | Posted | Mean | Standard Deviation | Units | 5-7 Days after Surgery and 28-35 Days after Surgery |
|
|
|
| Secondary | 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 | Posted | Mean | Standard Deviation | scores on a scale | 28-35 days |
|
|
|
| Secondary | 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 | Posted | Mean | Standard Deviation | scores on a scale | 5-7 days after surgery |
|
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | scores on a scale | 28-35 days after surgery |
|
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | scores on a scale | 5-7 Days after surgery |
|
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | scores on a scale | 28-35 Days after surgery |
|
|
|
| 162 |
| 4 |
| 162 |
| 44 |
| 162 |
| EG001 | Investigational Group 2 | Spiral MONOCRYL Plus | 0 | 161 | 4 | 161 | 46 | 161 |
| EG002 | Control groupEdit | PDS Plus or Monocryl Plus | 0 | 162 | 2 | 162 | 50 | 162 |
| Breast adenoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | study protocol | Systematic Assessment |
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| Haemangioma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | study protocol | Systematic Assessment |
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| Metastatic lymphoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | study protocol | Systematic Assessment |
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| Post procedural haemorrhage | Injury, poisoning and procedural complications | study protocol | Systematic Assessment |
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| Supraventricular tachycardia | Cardiac disorders | study protocol | Systematic Assessment |
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| Asthenia | Gastrointestinal disorders | study protocol | Systematic Assessment | General disorders and administration site conditions |
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| Skin oedema | Skin and subcutaneous tissue disorders | study protocol | Systematic Assessment |
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| Hypocalcaemia | Metabolism and nutrition disorders | study protocol | Systematic Assessment |
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| Cough | Respiratory, thoracic and mediastinal disorders | study protocol | Systematic Assessment |
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The disclosure restriction on the principal investigator(PI) is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than or equal to 60 days from the time submitted to the sponsor for review. The sponsor cannot require changes to the communication and cannot extend the embargo.
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