SuturesNautilusNCT03792737
A Study of Two Types of Absorbable Surgical Sutures in the Suturing of Thyroid Surgery Incision
A study testing Spiral PDS Plus, Spiral MONOCRYL Plus and PDS Plus in people with Sutures, run by Ethicon, Inc. at 10 sites in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 69 years
- Conditions the study is for
- Sutures
- What is being tested?
- Spiral PDS Plus, Spiral MONOCRYL Plus and PDS Plus
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 501 participants
- Where
- 10 sitesChina
- Study dates
- 1 Apr 2019to 6 Jan 2020
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 69 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
Show all 15Show fewer
- 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.
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
China10 sites
Beijing Friendship Hospital, Capital Medical University
Beijing, 100050
West China Hospital, Sichuan University
Chengdu, Sichuan, 610041
Fujian Medical University Union Hospital
Fuzhou, Fujian, 350001
The First Affiliated Hospital, Zhejiang University
Hangzhou, Zhejiang, 310006
Jiangsu Province Hospital
Nanjing, Jiangsu, 210029
The First Hospital of China Medical University
Shenyang, Liaoning, 110001
Peking University Shenzhen Hospital
Shenzhen, Guangdong, 518035
Union Hospital Tongji Medical college Huazhong University of science and technologyUnion Hospital Tongji Medical college Huazhong University of science and technology
Wuhan, Hubei, 430022
The First Affiliated Hospital of Xi'An Jiaotong University
Xi’an, Shanxi, 710061
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, 450052
About this study
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
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.
Read the 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.
- Conditions
- Sutures
- Being tested
- Spiral PDS Plus, Spiral MONOCRYL Plus, PDS Plus, MONOCRYL Plus, VICRYL Plus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Spiral PDS PlusDevice
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.
Spiral MONOCRYL PlusDevice
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.
PDS PlusDevice
PDS Plus is a non-barbed antibacterial monofilament, synthetic absorbable suture. The suture contains triclosan, a broad spectrum antibacterial agent.
MONOCRYL PlusDevice
MONOCRYL Plus is a non-barbed antibacterial monofilament, synthetic absorbable suture. The suture contains triclosan, a broad spectrum antibacterial agent.
VICRYL PlusDevice
VICRYL Plus antibacterial suture is a non-barbed synthetic absorbable sterile, surgical suture. The suture contains triclosan, a broad spectrum antibacterial agent.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Spiral PDS Plus; Device: MONOCRYL Plus; Device: VICRYL Plus |
| 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. Receives: Device: Spiral MONOCRYL Plus; Device: PDS Plus; Device: VICRYL Plus |
| 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. Receives: Device: PDS Plus; Device: MONOCRYL Plus; Device: VICRYL Plus |
What is being measured
The primary outcome is the main question the study is designed to answer.
Wound Healing Grade
Percentage of Participants with Grade A Healing of Surgical Incision
Measured: 5-7days
Secondary outcomes (7)
Incision Closure Time
the time required from the first needle insertion for stitching ribbon muscles to the completion of intradermal suture (minutes)
Measured: 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.
Measured: 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
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 28-35 Days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jan 2019
- Study start1 Apr 2019
- Primary completion12 Dec 2019
- Study completion6 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for SuturesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 501 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ethicon, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Hao Zhang, Principal investigator, First Hospital of China Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03792737
- Sponsor's protocol ID
- ESC-201702
- Acronym
- Nautilus
- Status last verified
- Feb 2022
- First submitted
- 29 Nov 2018
- Last updated
- 5 Apr 2022
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03792737
- Acronym / sponsor ID
- Nautilus / ESC-201702
- Conditions
- Sutures
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 501 participants (actual)
- Lead sponsor
- Ethicon, Inc.Industry (pharma, biotech, devices)
- Study start
- 1 Apr 2019 (actual)
- Primary completion
- 12 Dec 2019 (actual)
- Study completion
- 6 Jan 2020 (actual)
- First posted
- 3 Jan 2019 (actual)
- Results
- Posted 29 Jan 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Investigational group 1 | Experimental | Device: Spiral PDS Plus, Device: MONOCRYL Plus, Device: VICRYL PlusInvestigational 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. |
| Investigational group 2 | Experimental | Device: Spiral MONOCRYL Plus, Device: PDS Plus, Device: VICRYL PlusInvestigational 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. |
| Control group | Active comparator | Device: PDS Plus, Device: MONOCRYL Plus, Device: VICRYL PlusControl 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. |
Who may qualify
- Ages
- 18 to 69 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (15 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Spiral PDS PlusThe 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. | Device | Investigational group 1 |
| Spiral MONOCRYL PlusThe 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. | Device | Investigational group 2 |
| PDS PlusPDS Plus is a non-barbed antibacterial monofilament, synthetic absorbable suture. The suture contains triclosan, a broad spectrum antibacterial agent. | Device | Control group, Investigational group 2 |
| MONOCRYL PlusMONOCRYL Plus is a non-barbed antibacterial monofilament, synthetic absorbable suture. The suture contains triclosan, a broad spectrum antibacterial agent. | Device | Control group, Investigational group 1 |
| VICRYL PlusVICRYL Plus antibacterial suture is a non-barbed synthetic absorbable sterile, surgical suture. The suture contains triclosan, a broad spectrum antibacterial agent. | Device | Control group, Investigational group 1, Investigational group 2 |
Primary outcome
Wound Healing Grade
Time frame: 5-7days
Percentage of Participants with Grade A Healing of Surgical Incision
7 secondary outcomes
Incision Closure Time
Time frame: during surgery, an average of around 12 Mins
Postoperative Incisional Pain Score (Visual Analogue Scale, VAS)
Time frame: 5-7 Days after Surgery and 28-35 Days after Surgery
Modified Hollander Wound Evaluation Scale - FAS
Time frame: 28-35 days
Health Related Quality of Life Scale (EQ-5D-5L)
Time frame: 5-7 days after surgery
Health Related Quality of Life Scale (EQ-5D-5L)
Time frame: 28-35 days after surgery
Summary of EQ-5D VAS Score
Time frame: 5-7 Days after surgery
Summary of EQ-5D VAS Score
Time frame: 28-35 Days after surgery
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Apr 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Sutures
Recruiting
Permanent Versus Slowly Dissolving Stitches for Non-Mesh (Shouldice) Groin Hernia Repair
Inguinal Hernia
Recruiting
Duramesh Versus Minimally Invasive IPOM for High-Risk Umbilical Hernia Repairs
Umbilical Hernia, Ventral Hernia
Recruiting
Comparing a Suture-based System for the Removal of Arterial and Veinous ECMO Cannulas to the Standard Approach
VA-ECMO
RecruitingObservational study
Novosyn® CHD vs Polyglactin 910 Suture to Close Wounds After Emergency or Elective Laparotomy or Laparoscopic Surgery
Surgical Site Infection
Recruiting
Comparing Two Laparoscopic Techniques for Hernia Repair in Children
Inguinal Hernia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hao Zhang principal investigator
First Hospital of China Medical University
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Spiral PDS Plus, Spiral MONOCRYL Plus and PDS Plus in people with Sutures, run by Ethicon, Inc. at 10 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 29 Jan 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Wound Healing Grade (time frame: 5-7days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Apr 2022.