Arthroplasty, Replacement, KneePhase 4ZIPSNCT02255877
ZIPS Study - Zip Incision Approximation vs. STAPLE
A Phase 4 study testing Zip Surgical Skin Closure and Steel Staples in people with Arthroplasty, Replacement, Knee, run by ZipLine Medical Inc. at 1 site in United States.
Trial summary
Study designed to evaluate the Zip Surgical Skin Closure device versus conventional steel staple placement when utilized for surgical wound closure after bi lateral unicompartmental or bi later total knee replacement. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Arthroplasty, Replacement, Knee
- 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
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2014to Sep 2014
- Phase
- Phase 4
- Are there results?
- None posted in the registry
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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients requiring epidermal closure after bi lateral total or partial (unicompartmental) knee arthroplasty;
- Patients willing to be evaluated at discharge and 6-weeks 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.
United States1 site
Orthopaedic Research Foundation
Indianapolis, Indiana, 46278
About this study
Official title: A Prospective, Non Blinded, Randomized Controlled Post Market Study Designed to Compare the Use of the Zip Surgical Skin Closure Device vs. Conventional Steel Staples for Skin Closure in Subjects Who Undergo a bi Lateral Knee Arthroplasty
Study designed to evaluate the Zip Surgical Skin Closure device versus conventional steel staple placement when utilized for surgical wound closure after bi lateral unicompartmental or bi later total knee replacement.
Read the detailed description
This is a randomized, within patient control study aiming to enroll up to 25 subjects requiring bi lateral knee arthroplasty (unicompartmental or toal) at a single study center. Subjects will be followed for up for 6 weeks post surgery to evaluate wound healing and overall satisfaction of closure methods.
- Conditions
- Arthroplasty, Replacement, Knee
- Being tested
- Zip Surgical Skin Closure, Steel Staples
- Keywords
- Bi lateral knee surgery, uni compartmental
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 Zip 16, Zip 8i
Non invasive skin closure device for closure of the skin layer for surgical incisions or laceration repair.
Steel StaplesDevice
Skin Closure device for the closure of the skin layer for surgical incisions.
| Study group | Role | What they receive |
|---|---|---|
| Zip Surgical Skin Closure | Active comparator | Subjects randomized to receive one knee (left or right) closed with ZipSurgical Skin Closure and the other knee closed with standard staples Receives: Device: Zip Surgical Skin Closure; Device: Steel Staples |
| Steel Staples | Active comparator | Subjects randomized to receive one knee (left or right) closed with Staples and the other knee closed with ZipSurgical Skin Closure Receives: Device: Zip Surgical Skin Closure; Device: Steel Staples |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effectiveness Outcome - Wound Healing
Wound healing as judged by the Cosmetic Visual Analogue Scale - Photos taken at 6 weeks post surgery will be judged by panel of Plastic Surgeons blinded to the treatment assignments.
Measured: 6 weeks post surgery
Secondary outcomes (3)
Surgeon Satisfaction with the Closure Method
Closure Method satisfaction (Zip and Staple) will be collected with a 5 point satisfaction scale (from very satisfied to very dissatisfied)
Measured: At Discharge, 1-3 days post surgery
Patient Pain
General post operative and incisional pain levels will be collected using a 10 point VAS scale
Measured: Throughout 6 week study period (Discharge, 2 week follow up and 6 week follow up (exit) visits.)
Patient Satisfaction of Scars
Scar satisfaction (Zip and Staple) will be collected with a 5 point satisfaction scale (from very satisfied to very dissatisfied) and with a 10 point VAS scale
Measured: At 6 week Follow up (exit) visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2014 (estimated)
- Study startSep 2014
- Primary completionSep 2014
- Study completionSep 2014
Why it stopped: Change in research plan
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Arthroplasty, Replacement, KneeStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- ZipLine Medical Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Eric Storne, Study director, VP Marketing
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02255877
- Sponsor's protocol ID
- 005
- Acronym
- ZIPS
- Status last verified
- Oct 2016
- First submitted
- 26 Sep 2014
- Last updated
- 24 Oct 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Non Blinded, Randomized Controlled Post Market Study Designed to Compare the Use of the Zip Surgical Skin Closure Device vs. Conventional Steel Staples for Skin Closure in Subjects Who Undergo a bi Lateral Knee Arthroplasty
- ClinicalTrials.gov ID
- NCT02255877
- Acronym / sponsor ID
- ZIPS / 005
- Conditions
- Arthroplasty, Replacement, Knee
- Keywords
- Bi lateral knee surgery, uni compartmental
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Change in research plan
- Enrolment
- 0 participants (actual)
- Lead sponsor
- ZipLine Medical Inc.Industry (pharma, biotech, devices)
- Study start
- Sep 2014
- Primary completion
- Sep 2014 (actual)
- Study completion
- Sep 2014 (actual)
- First posted
- 3 Oct 2014 (estimated)
- Results
- Not posted in the source record
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 evaluate the Zip Surgical Skin Closure device versus conventional steel staple placement when utilized for surgical wound closure after bi lateral unicompartmental or bi later total knee replacement.
Detailed description
This is a randomized, within patient control study aiming to enroll up to 25 subjects requiring bi lateral knee arthroplasty (unicompartmental or toal) at a single study center. Subjects will be followed for up for 6 weeks post surgery to evaluate wound healing and overall satisfaction of closure methods.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Zip Surgical Skin Closure | Active comparator | Device: Zip Surgical Skin Closure, Device: Steel StaplesSubjects randomized to receive one knee (left or right) closed with ZipSurgical Skin Closure and the other knee closed with standard staples |
| Steel Staples | Active comparator | Device: Zip Surgical Skin Closure, Device: Steel StaplesSubjects randomized to receive one knee (left or right) closed with Staples and the other knee closed with ZipSurgical Skin Closure |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients requiring epidermal closure after bi lateral total or partial (unicompartmental) knee arthroplasty;
- Patients willing to be evaluated at discharge and 6-weeks 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: Zip 16, Zip 8iNon invasive skin closure device for closure of the skin layer for surgical incisions or laceration repair. | Device | Steel Staples, Zip Surgical Skin Closure |
| Steel StaplesSkin Closure device for the closure of the skin layer for surgical incisions. | Device | Steel Staples, Zip Surgical Skin Closure |
Primary outcome
Effectiveness Outcome - Wound Healing
Time frame: 6 weeks post surgery
Wound healing as judged by the Cosmetic Visual Analogue Scale - Photos taken at 6 weeks post surgery will be judged by panel of Plastic Surgeons blinded to the treatment assignments.
3 secondary outcomes
Surgeon Satisfaction with the Closure Method
Time frame: At Discharge, 1-3 days post surgery
Patient Pain
Time frame: Throughout 6 week study period (Discharge, 2 week follow up and 6 week follow up (exit) visits.)
Patient Satisfaction of Scars
Time frame: At 6 week Follow up (exit) visit
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Oct 2016.
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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.
Eric Storne study director
VP Marketing
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Zip Surgical Skin Closure and Steel Staples in people with Arthroplasty, Replacement, Knee, 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 2 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: withdrawn, as of the sponsor's last update on 24 Oct 2016. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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?
Effectiveness Outcome - Wound Healing (time frame: 6 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 24 Oct 2016.