Sutures
Conditions
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.
Interventions
DEVICESpiral PDS Plus
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.
DEVICESpiral MONOCRYL Plus
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.
DEVICEPDS Plus
PDS Plus is a non-barbed antibacterial monofilament, synthetic absorbable suture. The suture contains triclosan, a broad spectrum antibacterial agent.
DEVICEMONOCRYL Plus
MONOCRYL Plus is a non-barbed antibacterial monofilament, synthetic absorbable suture. The suture contains triclosan, a broad spectrum antibacterial agent.
DEVICEVICRYL Plus
VICRYL Plus antibacterial suture is a non-barbed synthetic absorbable sterile, surgical suture. The suture contains triclosan, a broad spectrum antibacterial agent.
Sponsors
Ethicon, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 69 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Wound Healing Grade | 5-7days | Percentage of Participants with Grade A Healing of Surgical Incision |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incision Closure Time | during surgery, an average of around 12 Mins | the time required from the first needle insertion for stitching ribbon muscles to the completion of intradermal suture (minutes) |
| Postoperative Incisional Pain Score (Visual Analogue Scale, VAS) | 5-7 Days after Surgery and 28-35 Days after Surgery | 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. |
| Modified Hollander Wound Evaluation Scale - FAS | 28-35 days | 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 |
| Health Related Quality of Life Scale (EQ-5D-5L) | 5-7 days after surgery | 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 |
| Summary of EQ-5D VAS Score | 5-7 Days after surgery | 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. |
Countries
China
Participant flow
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| Investigational Group 1 Spiral PDS Plus | 162 |
| Investigational Group 2 Spiral MONOCRYL Plus | 160 |
| Control groupEdit PDS Plus or Monocryl Plus | 162 |
| Total | 484 |
Baseline characteristics
| Characteristic | Investigational Group 1 | Investigational Group 2 | Control groupEdit | Total |
|---|---|---|---|---|
| Age, Continuous | 40.1 years STANDARD_DEVIATION 10.66 | 41.2 years STANDARD_DEVIATION 10.84 | 40.3 years STANDARD_DEVIATION 11.32 | 40.5 years STANDARD_DEVIATION 10.93 |
| Race/Ethnicity, Customized Han | 158 Participants | 157 Participants | 155 Participants | 470 Participants |
| Race/Ethnicity, Customized Other | 4 Participants | 3 Participants | 7 Participants | 14 Participants |
| Sex: Female, Male Female | 107 Participants | 118 Participants | 111 Participants | 336 Participants |
| Sex: Female, Male Male | 55 Participants | 42 Participants | 51 Participants | 148 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 162 | 0 / 161 | 0 / 162 |
| other Total, other adverse events | 44 / 162 | 46 / 161 | 50 / 162 |
| serious Total, serious adverse events | 4 / 162 | 4 / 161 | 2 / 162 |
Outcome results
Primary
Wound Healing Grade
Percentage of Participants with Grade A Healing of Surgical Incision
Time frame: 5-7days
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Investigational group1 | Wound Healing Grade | 99.35 percentage |
| Investigational group2 | Wound Healing Grade | 98.73 percentage |
| Control Group | Wound Healing Grade | 99.36 percentage |
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
Time frame: 5-7 days after surgery
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Investigational group1 | Health Related Quality of Life Scale (EQ-5D-5L) | 0.8627 scores on a scale | Standard Deviation 0.11007 |
| Investigational group2 | Health Related Quality of Life Scale (EQ-5D-5L) | 0.8537 scores on a scale | Standard Deviation 0.11843 |
| Control Group | Health Related Quality of Life Scale (EQ-5D-5L) | 0.8489 scores on a scale | Standard Deviation 0.11648 |
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.
Time frame: 28-35 days after surgery
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Investigational group1 | Health Related Quality of Life Scale (EQ-5D-5L) | 0.9159 scores on a scale | Standard Deviation 0.10566 |
| Investigational group2 | Health Related Quality of Life Scale (EQ-5D-5L) | 0.9024 scores on a scale | Standard Deviation 0.10738 |
| Control Group | Health Related Quality of Life Scale (EQ-5D-5L) | 0.9230 scores on a scale | Standard Deviation 0.10489 |
Secondary
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Investigational group1 | Incision Closure Time | 11.285 minutes | Standard Deviation 3.2635 |
| Investigational group2 | Incision Closure Time | 11.198 minutes | Standard Deviation 3.1298 |
| Control Group | Incision Closure Time | 11.634 minutes | Standard Deviation 3.4327 |
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
Time frame: 28-35 days
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Investigational group1 | Modified Hollander Wound Evaluation Scale - FAS | 0.2 scores on a scale | Standard Deviation 0.53 |
| Investigational group2 | Modified Hollander Wound Evaluation Scale - FAS | 0.1 scores on a scale | Standard Deviation 0.38 |
| Control Group | Modified Hollander Wound Evaluation Scale - FAS | 0.1 scores on a scale | Standard Deviation 0.45 |
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.
Time frame: 5-7 Days after Surgery and 28-35 Days after Surgery
Population: Full Analysis Set
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Investigational group1 | Postoperative Incisional Pain Score (Visual Analogue Scale, VAS) | VAS Scale-Visit 4 (5-7 Days after Surgery) | 1.5 Units | Standard Deviation 1.49 |
| Investigational group1 | Postoperative Incisional Pain Score (Visual Analogue Scale, VAS) | VAS Scale-Visit 5 (28-35 Days after Surgery) | 0.45 Units | Standard Deviation 0.775 |
| Investigational group2 | Postoperative Incisional Pain Score (Visual Analogue Scale, VAS) | VAS Scale-Visit 4 (5-7 Days after Surgery) | 1.5 Units | Standard Deviation 1.61 |
| Investigational group2 | Postoperative Incisional Pain Score (Visual Analogue Scale, VAS) | VAS Scale-Visit 5 (28-35 Days after Surgery) | 0.63 Units | Standard Deviation 0.991 |
| Control Group | Postoperative Incisional Pain Score (Visual Analogue Scale, VAS) | VAS Scale-Visit 4 (5-7 Days after Surgery) | 1.4 Units | Standard Deviation 1.39 |
| Control Group | Postoperative Incisional Pain Score (Visual Analogue Scale, VAS) | VAS Scale-Visit 5 (28-35 Days after Surgery) | 0.66 Units | Standard Deviation 1.319 |
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.
Time frame: 28-35 Days after surgery
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Investigational group1 | Summary of EQ-5D VAS Score | 91.2 scores on a scale | Standard Deviation 8.95 |
| Investigational group2 | Summary of EQ-5D VAS Score | 91.7 scores on a scale | Standard Deviation 7.83 |
| Control Group | Summary of EQ-5D VAS Score | 92.3 scores on a scale | Standard Deviation 7.88 |
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.
Time frame: 5-7 Days after surgery
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Investigational group1 | Summary of EQ-5D VAS Score | 88.1 scores on a scale | Standard Deviation 10.02 |
| Investigational group2 | Summary of EQ-5D VAS Score | 87.7 scores on a scale | Standard Deviation 10.32 |
| Control Group | Summary of EQ-5D VAS Score | 88.3 scores on a scale | Standard Deviation 9.45 |