Arthroplasty, Knee ReplacementNCT02460172
Zip® Surgical Skin Closure Device vs. Staples for Skin Closure in Subjects Having Undergone Bilateral Knee Arthroplasty
A study testing Zip Surgical Skin Closure and Steel Staples in people with Arthroplasty, Knee Replacement and Wound Healing, run by ZipLine Medical Inc. at 1 site in United States.
Trial summary
Study designed to compare the Zip Surgical Skin Closure device vs. conventional staples for wound closure following bi lateral knee replacement surgery. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Arthroplasty, Knee Replacement, Wound Healing
- What is being tested?
- Zip Surgical Skin Closure and Steel Staples
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- May 2015to 15 Feb 2017
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients 18 years of age and older
- Patients requiring epidermal closure after bi lateral total or partial (unicompartmental) knee arthroplasty
- Patients willing to be evaluated at discharge, 2 weeks, and at the 6 to 8 week post op
Who cannot join
- Known bleeding disorder not caused by medication
- Known personal or family history of keloid formation or scar hypertrophy
- Known allergy or hypersensitivity to non-latex skin adhesives
- Atrophic skin deemed clinically prone to blistering
- Any skin disorder affecting wound healing
- Any other condition that in the opinion of the investigator would make a particular patient unsuitable for this study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Prospective, Randomized Controlled Post-market Study to Compare the Use of the Zip® Surgical Skin Closure Device Versus Conventional Staples for Skin Closure in Subjects Having Undergone Bilateral Knee Arthroplasty
Study designed to compare the Zip Surgical Skin Closure device vs. conventional staples for wound closure following bi lateral knee replacement surgery.
Read the detailed description
Prospective, randomized, within patient control study comparing the use of Zip Surgical Skin Closure device versus conventional staple placement when utilized for surgical wound closure after bi lateral unicompartmental or bi lateral total knee replacement. A total of up to 25 patients will be enrolled and followed for up to 8 weeks post surgery to evaluate wound healing and overall satisfaction of closure method.
- Conditions
- Arthroplasty, Knee Replacement, Wound Healing
- Being tested
- Zip Surgical Skin Closure, Steel Staples
- Keywords
- bi lateral, knee surgery, arthroplasty, orthopedics
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Zip Surgical Skin ClosureDevice
Also called Zip16, Zip 8i
Non invasive, reversible, skin closure device for closure of the skin layer following surgical incisions or laceration repair.
Steel StaplesDevice
Also called Conventional staples
Skin closure device for the closure of the skin layer following surgical incision
| Study group | Role | What they receive |
|---|---|---|
| Zip Surgical Skin Closure | Active comparator | Subject will be randomized to receive one knee (right or left) closed with Zip Surgical Skin Closure and the other knee closed with steel staples. Receives: Device: Zip Surgical Skin Closure |
| Steel Staples | Active comparator | Subject will be randomized to receive one knee (right or left) closed with steel staples and the other knee closed with Zip Surgical Skin Closure. Receives: Device: Steel Staples |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incision Appearance / Scar Cosmesis
Patient Scar Rating (0=Best to 10=Worst). A lower score means better scar rating.
Surgeon Scar Rating (0=Best to 10=Worst). A lower score means better scar rating.
Independent Plastic Surgeon Scar Rating by 8 week post op photos. (0=Best to 10=Worst). A lower score means better scar rating.
Measured: 6-8 weeks post surgery
Secondary outcomes (4)
Surgeon Closure Method Satisfaction
Closure method satisfaction will be collected by a 5 point satisfaction scale:
- Very Satisfied
- Satisfied
- Neither
- Dissatisfied
- Very Dissatisfied A lower score means more satisfaction with the closure method.
Measured: 6-8 weeks post op
Patient Pain - Incisional and General
Pain levels will be collected using a 10 point VAS scale.
Measured: Throughout 8 week study period (Discharge, 2 wk follow up and 8 wk exit visit)
Surgeon and Patient Scar Satisfaction
Scar Satisfaction (both Zip and Staple sides) will be collected using a 5 point scale:
Very Satisfied Satisfied Neither Dissatisfied Very Dissatisfied
Measured: 6 to 8 wk follow up visit
Range of Motion
Knee Range of Motion for each knee will be measured in degrees
Measured: 2 weeks and 6-8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2015 (estimated)
- Study startMay 2015
- Primary completion15 Feb 2017
- Study completion15 Feb 2017
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 Arthroplasty, Knee ReplacementStudies 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
- Outcomes assessor
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- ZipLine Medical Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Rodney Benner, MD, Principal investigator, Study Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02460172
- Sponsor's protocol ID
- 006
- Status last verified
- Feb 2019
- First submitted
- 28 May 2015
- Last updated
- 5 Mar 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Randomized Controlled Post-market Study to Compare the Use of the Zip® Surgical Skin Closure Device Versus Conventional Staples for Skin Closure in Subjects Having Undergone Bilateral Knee Arthroplasty
- ClinicalTrials.gov ID
- NCT02460172
- Acronym / sponsor ID
- 006
- Conditions
- Arthroplasty, Knee Replacement, Wound Healing
- Keywords
- bi lateral, knee surgery, arthroplasty, orthopedics
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- ZipLine Medical Inc.Industry (pharma, biotech, devices)
- Study start
- May 2015 (actual)
- Primary completion
- 15 Feb 2017 (actual)
- Study completion
- 15 Feb 2017 (actual)
- First posted
- 2 Jun 2015 (estimated)
- Results
- Posted 5 Mar 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Study designed to compare the Zip Surgical Skin Closure device vs. conventional staples for wound closure following bi lateral knee replacement surgery.
Detailed description
Prospective, randomized, within patient control study comparing the use of Zip Surgical Skin Closure device versus conventional staple placement when utilized for surgical wound closure after bi lateral unicompartmental or bi lateral total knee replacement. A total of up to 25 patients will be enrolled and followed for up to 8 weeks post surgery to evaluate wound healing and overall satisfaction of closure method.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Zip Surgical Skin Closure | Active comparator | Device: Zip Surgical Skin ClosureSubject will be randomized to receive one knee (right or left) closed with Zip Surgical Skin Closure and the other knee closed with steel staples. |
| Steel Staples | Active comparator | Device: Steel StaplesSubject will be randomized to receive one knee (right or left) closed with steel staples and the other knee closed with Zip Surgical Skin Closure. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients 18 years of age and older
- Patients requiring epidermal closure after bi lateral total or partial (unicompartmental) knee arthroplasty
- Patients willing to be evaluated at discharge, 2 weeks, and at the 6 to 8 week post op
Key exclusion criteria (6 listed)
- Known bleeding disorder not caused by medication
- Known personal or family history of keloid formation or scar hypertrophy
- Known allergy or hypersensitivity to non-latex skin adhesives
- Atrophic skin deemed clinically prone to blistering
- Any skin disorder affecting 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 |
|---|---|---|
| Zip Surgical Skin ClosureAlso: Zip16, Zip 8iNon invasive, reversible, skin closure device for closure of the skin layer following surgical incisions or laceration repair. | Device | Zip Surgical Skin Closure |
| Steel StaplesAlso: Conventional staplesSkin closure device for the closure of the skin layer following surgical incision | Device | Steel Staples |
Primary outcome
Incision Appearance / Scar Cosmesis
Time frame: 6-8 weeks post surgery
Patient Scar Rating (0=Best to 10=Worst). A lower score means better scar rating. Surgeon Scar Rating (0=Best to 10=Worst). A lower score means better scar rating. Independent Plastic Surgeon Scar Rating by 8 week post op photos. (0=Best to 10=Worst). A lower score means better scar rating.
4 secondary outcomes
Surgeon Closure Method Satisfaction
Time frame: 6-8 weeks post op
Patient Pain - Incisional and General
Time frame: Throughout 8 week study period (Discharge, 2 wk follow up and 8 wk exit visit)
Surgeon and Patient Scar Satisfaction
Time frame: 6 to 8 wk follow up visit
Range of Motion
Time frame: 2 weeks and 6-8 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2019.
- 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.
Rodney Benner, MD principal investigator
Study Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Zip Surgical Skin Closure and Steel Staples in people with Arthroplasty, Knee Replacement and Wound Healing, run by ZipLine Medical Inc. at 1 site in United States.
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 3 inclusion and 6 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 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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 5 Mar 2019). 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?
Incision Appearance / Scar Cosmesis (time frame: 6-8 weeks post 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 5 Mar 2019.