Wound ClosureSFXNCT03305887
Symmetric on Total Knee Arthroplasty (TKA)
A study testing "STRATAFIX™ Symmetric" Knotless Tissue, VICRYL® PLUS and "STRATAFIX Spiral" sutures in people with Wound Closure, run by Johnson & Johnson Medical, China at 7 sites in China.
Trial summary
A post-marketing prospective, multicenter, randomized controlled study to evaluate the wound closure efficiency of STRATAFIX™ Symmetric PDS™ Plus Knotless Tissue Control Device (STRATAFIX Symmetric PDS Plus) compared to conventional sutures in total knee arthroplasty (TKA) Read more about this study
- Who is it for?
- Ages 18 to 79 years
- Conditions the study is for
- Wound Closure
- What is being tested?
- "STRATAFIX™ Symmetric" Knotless Tissue, VICRYL® PLUS and "STRATAFIX Spiral" sutures
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 184 participants
- Where
- 7 sitesChina
- Study dates
- 12 Jun 2017to 21 May 2018
- 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 79 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient is ≥ 18 years and < 80 years of age;
- Patient with osteoarthritis is scheduled to undergo elective unilateral TKA;
- Patient is willing to participate in the study, comply with study requirements, follow-up schedule, and give written informed consent; and
- Patient agrees not to schedule any additional elective surgical procedures until participation in this study is complete.
Who cannot join
- Female patient who is pregnant or lactating at the time of screening;
- Patient has a Body Mass Index (BMI) > 40 kg/m2;
- Patient is not able to walk independently (inability to walk at least 10 consecutive meters without a walking aid);
- Patient has had a surgical intervention during the past 30 days for treatment of painful joint or its underlying etiology;
- Patient has had previous open surgeries on the affected joint other than arthroscopy;
- Patient has active infectious collagen diseases (i.e. scleroderma) or any other condition that would interfere with wound healing;
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- Patient is allergic to poly (p-dioxanone), triclosan (IRGACARE®* MP) or D\&C Violet No. 2;
- Patient has diabetes with poor control, defined as fasting plasma glucose (FPG) ≥ 10.0 mmol/L;
- Patient has a history of immunosuppressive drug use, including steroids, within the last 6 months;
- Patient has undergone chemotherapy or radiation within the last 6 months prior to study enrollment or is scheduled to do so during the study period;
- Patient has known personal or family history of keloid formation or hypertrophy;
- Patient has other dermatologic conditions known to impair wound healing;
- Patient is participating in any other investigational drug (within 30 days or 5 half-lives of an investigational drug) or device study;
- Patient has any physical or psychological condition which would impair study participation; and
- Patient is judged unsuitable for study participation by the investigator for any other reason.
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
China7 sites
Chinese PLA general hospital
Beijing, Beijing Municipality, 100000
Jilin University Chinese Japanese Friendship Hospital
Changchun, Jilin, 130033
NanFang Hospital
Guangzhou, Guangdong, 510000
The Second Affiliated Hospital of Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310009
Jiangsu province hospital
Nanjing, Jiangsu, 210000
Tongji Hospital affiliated Tongji medical college huazhonguniversity of science&technology
Wuhan, Hubei, 430000
second affiliated hospital of Xi'an Jiaotong university
Xi’an, Shanxi, 710004
About this study
Official title: A Prospective, Multicenter, Randomized Controlled Study to Evaluate the Wound Closure Efficiency of STRATAFIX™ Symmetric PDS™ Plus Knotless Tissue Control Device Compared to Conventional Sutures in Total Knee Arthroplasty (TKA)
A post-marketing prospective, multicenter, randomized controlled study to evaluate the wound closure efficiency of STRATAFIX™ Symmetric PDS™ Plus Knotless Tissue Control Device (STRATAFIX Symmetric PDS Plus) compared to conventional sutures in total knee arthroplasty (TKA)
Read the detailed description
The primary objective of this prospective, randomized controlled study is to evaluate the wound closure efficiency of STRATAFIX Symmetric PDS Plus compared to conventional sutures in patients undergoing TKA. For the purpose of this study, wound closure efficiency is defined as the total time required to close the surgical incisions in patients undergoing TKA procedures using STRATAFIX Symmetric PDS Plus compared to those using traditional sutures. Secondary objectives will include the evaluation of differences in overall surgical procedure time, operating room (OR) time, length of stay, procedure costs, quality of life measures including pain, and range of motion (ROM). In addition, the difference in the safety profiles for both wound closure procedures will be evaluated through the analysis of the incidence of wound complications including dehiscence, wound infections, and other adverse events.
- Conditions
- Wound Closure
- Being tested
- "STRATAFIX™ Symmetric" Knotless Tissue, VICRYL® PLUS, "STRATAFIX Spiral" sutures, DERMABOND™ Advance™ Skin Closure System
- Keywords
- TKA, Barbed suture, Surgical time
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
"STRATAFIX™ Symmetric" Knotless TissueDevice
Also called STRATAFIX Symmetric
This devices will be used in deep and intermediate layers of barbed suture group.
VICRYL® PLUSDevice
Also called Polyglactin 910
This devices will be used in deep and intermediate layers of conventional suture group.
"STRATAFIX Spiral" suturesDevice
Also called Spiral
This devices will be used in intradermal layer of both barbed suture and conventional suture group.
DERMABOND™ Advance™ Skin Closure SystemDevice
Also called DERMABOND
This devices will be used in skin layer of both barbed suture and conventional suture group.
| Study group | Role | What they receive |
|---|---|---|
| Barbed suture group | Experimental | The deep layer and the intermediate layer will be repaired and closed by using one "STRATAFIX™ Symmetric" Knotless Tissue suture respectively. STRATAFIX Spiral sutures will be used to close the intradermal layer and the DERMABOND™ Advance™ Skin Closure System, a topical skin adhesive (TSA) will be applied to the skin surface to tissue approximation. Receives: Device: "STRATAFIX™ Symmetric" Knotless Tissue; Device: "STRATAFIX Spiral" sutures; Device: DERMABOND™ Advance™ Skin Closure System |
| Conventional suture group | Active comparator | VICRYL® Plus sutures will be used to close the deep and the intermediate layers with interrupted suturing manner. STRATAFIX Spiral sutures will be used to close the intradermal layer and the DERMABOND™ Advance™ Skin Closure System, a topical skin adhesive (TSA) will be applied to the skin surface to tissue approximation. Receives: Device: VICRYL® PLUS; Device: "STRATAFIX Spiral" sutures; Device: DERMABOND™ Advance™ Skin Closure System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Suturing Time
The total time required to close the surgical incisions between treatment groups.
Measured: During Surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2017
- Study start12 Jun 2017
- Primary completion13 Apr 2018
- Study completion21 May 2018
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 Wound ClosureStudies 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 184 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johnson & Johnson Medical, China
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Second Affiliated Hospital of Xi'an Jiaotong University, Second Affiliated Hospital, Zhejiang University, School of Medicine, China-Japan Union Hospital, Jilin University, Nanfang Hospital, Southern Medical University, Tongji Hospital, Chinese PLA General Hospital, The First Affiliated Hospital with Nanjing Medical University
- Responsible party
- Sponsor
- Investigators
- Patty Schleckser, Study director, Ethicon, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03305887
- Sponsor's protocol ID
- ESC-16-001
- Acronym
- SFX
- Status last verified
- Dec 2019
- First submitted
- 13 Jan 2017
- Last updated
- 13 Jan 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Multicenter, Randomized Controlled Study to Evaluate the Wound Closure Efficiency of STRATAFIX™ Symmetric PDS™ Plus Knotless Tissue Control Device Compared to Conventional Sutures in Total Knee Arthroplasty (TKA)
- ClinicalTrials.gov ID
- NCT03305887
- Acronym / sponsor ID
- SFX / ESC-16-001
- Conditions
- Wound Closure
- Keywords
- TKA, Barbed suture, Surgical time
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 184 participants (actual)
- Lead sponsor
- Johnson & Johnson Medical, ChinaIndustry (pharma, biotech, devices)
- Collaborators
- Second Affiliated Hospital of Xi'an Jiaotong University, Second Affiliated Hospital, Zhejiang University, School of Medicine, China-Japan Union Hospital, Jilin University, Nanfang Hospital, Southern Medical University, Tongji Hospital, Chinese PLA General Hospital, The First Affiliated Hospital with Nanjing Medical University
- Study start
- 12 Jun 2017 (actual)
- Primary completion
- 13 Apr 2018 (actual)
- Study completion
- 21 May 2018 (actual)
- First posted
- 10 Oct 2017 (actual)
- Results
- Posted 13 Jan 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A post-marketing prospective, multicenter, randomized controlled study to evaluate the wound closure efficiency of STRATAFIX™ Symmetric PDS™ Plus Knotless Tissue Control Device (STRATAFIX Symmetric PDS Plus) compared to conventional sutures in total knee arthroplasty (TKA)
Detailed description
The primary objective of this prospective, randomized controlled study is to evaluate the wound closure efficiency of STRATAFIX Symmetric PDS Plus compared to conventional sutures in patients undergoing TKA. For the purpose of this study, wound closure efficiency is defined as the total time required to close the surgical incisions in patients undergoing TKA procedures using STRATAFIX Symmetric PDS Plus compared to those using traditional sutures. Secondary objectives will include the evaluation of differences in overall surgical procedure time, operating room (OR) time, length of stay, procedure costs, quality of life measures including pain, and range of motion (ROM). In addition, the difference in the safety profiles for both wound closure procedures will be evaluated through the analysis of the incidence of wound complications including dehiscence, wound infections, and other adverse events.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Barbed suture group | Experimental | Device: "STRATAFIX™ Symmetric" Knotless Tissue, Device: "STRATAFIX Spiral" sutures, Device: DERMABOND™ Advance™ Skin Closure SystemThe deep layer and the intermediate layer will be repaired and closed by using one "STRATAFIX™ Symmetric" Knotless Tissue suture respectively. STRATAFIX Spiral sutures will be used to close the intradermal layer and the DERMABOND™ Advance™ Skin Closure System, a topical skin adhesive (TSA) will be applied to the skin surface to tissue approximation. |
| Conventional suture group | Active comparator | Device: VICRYL® PLUS, Device: "STRATAFIX Spiral" sutures, Device: DERMABOND™ Advance™ Skin Closure SystemVICRYL® Plus sutures will be used to close the deep and the intermediate layers with interrupted suturing manner. STRATAFIX Spiral sutures will be used to close the intradermal layer and the DERMABOND™ Advance™ Skin Closure System, a topical skin adhesive (TSA) will be applied to the skin surface to tissue approximation. |
Who may qualify
- Ages
- 18 to 79 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patient is ≥ 18 years and < 80 years of age;
- Patient with osteoarthritis is scheduled to undergo elective unilateral TKA;
- Patient is willing to participate in the study, comply with study requirements, follow-up schedule, and give written informed consent; and
- Patient agrees not to schedule any additional elective surgical procedures until participation in this study is complete.
Key exclusion criteria (15 listed)
- Female patient who is pregnant or lactating at the time of screening;
- Patient has a Body Mass Index (BMI) > 40 kg/m2;
- Patient is not able to walk independently (inability to walk at least 10 consecutive meters without a walking aid);
- Patient has had a surgical intervention during the past 30 days for treatment of painful joint or its underlying etiology;
- Patient has had previous open surgeries on the affected joint other than arthroscopy;
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 |
|---|---|---|
| "STRATAFIX™ Symmetric" Knotless TissueAlso: STRATAFIX SymmetricThis devices will be used in deep and intermediate layers of barbed suture group. | Device | Barbed suture group |
| VICRYL® PLUSAlso: Polyglactin 910This devices will be used in deep and intermediate layers of conventional suture group. | Device | Conventional suture group |
| "STRATAFIX Spiral" suturesAlso: SpiralThis devices will be used in intradermal layer of both barbed suture and conventional suture group. | Device | Barbed suture group, Conventional suture group |
| DERMABOND™ Advance™ Skin Closure SystemAlso: DERMABONDThis devices will be used in skin layer of both barbed suture and conventional suture group. | Device | Barbed suture group, Conventional suture group |
Primary outcome
Suturing Time
Time frame: During Surgery
The total time required to close the surgical incisions between treatment groups.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
Patty Schleckser study director
Ethicon, Inc.
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing "STRATAFIX™ Symmetric" Knotless Tissue, VICRYL® PLUS and "STRATAFIX Spiral" sutures in people with Wound Closure, run by Johnson & Johnson Medical, China at 7 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 4 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 13 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 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 13 Jan 2020). 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?
Suturing Time (time frame: During Surgery). 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 13 Jan 2020.