Wounds and InjuriesZIPS3NCT03201536
ZipLine Incision Approximation Verses Suture:ZIPS3 Physician Preference Study
A study testing conventional Suture and Zip3 in people with Wounds and Injuries, run by ZipLine Medical Inc. at 3 sites in United States.
Trial summary
Zipline incision approximation vs. Suture -- zips 3 study. A prospective, multi-site, non-blinded, randomized controlled, study designed to evaluate user preferences associated with use of the zipline 3 system versus conventional suturing for incision closure. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Wounds and Injuries
- What is being tested?
- conventional Suture and Zip3
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 3 sitesUnited States
- Study dates
- Oct 2012to Oct 2012
- Phase
- Interventional
- 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 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients between 18 and 75 years of age
- In generally good health
- Willing to be evaluated in 5-14 days and 3-months post op
- Patient requiring a non-emergent skin incision or biopsy
- Maximum excision size 1.5x3.0 cm
- Requiring 4-0 or smaller suture for closure
- In area of body trunk or extremities with low mobility and tension
Who cannot join
- Facial Incisions or incisions in high stress or tension areas
- Previously diagnosed peripheral vascular disease
- Insulin-dependent diabetes mellitus
- Known bleeding diathesis
- Known personal or family history of keloid formation or scar hypertrophy
- Known allergy or hypersensitivity to adhesives
Show all 11Show fewer
- Presently taking steroids, immune stimulants, beta blockers, or anticoagulants
- Atrophic skin deemed clinically prone to blistering
- Any skin disorder affecting wound healing
- Incisions requiring dermal sutures
- Any other condition that in the opinion of the investigator would make a particular patient unsuitable for this study
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Palo Alto Medical Foundation
Palo Alto, California, 94301
Plastic Surgery Institute of Northern California
San Francisco, California, 94114
California Pacific Medical Center
San Francisco, California, 94115
About this study
Official title: ZipLine Incision Approzimation Vs. Suture:Zips3 Physician Preference Study
Zipline incision approximation vs. Suture -- zips 3 study. A prospective, multi-site, non-blinded, randomized controlled, study designed to evaluate user preferences associated with use of the zipline 3 system versus conventional suturing for incision closure.
Read the detailed description
The objective of this study is to evaluate user preferences associated with the ZipLine 3 system versus conventional suture placement.
- Conditions
- Wounds and Injuries
- Being tested
- conventional Suture, Zip3
- Keywords
- ZipLine3 device vs. conventional sutures
- Medical subject headings
- Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
conventional SutureDevice
Also called stitches,PeriStrips
Sutures
Zip3Device
wound closure device
| Study group | Role | What they receive |
|---|---|---|
| sutures | Active comparator | zipLine3 device verses conventional sutures Receives: Device: conventional Suture |
| Zip3 Device | Active comparator | Not described Receives: Device: Zip3 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Wound healing
Wound healing as judged by the CVAS (Cosmetic Visual Analogue Scale) wound healing scale
Measured: 3-month
Secondary outcomes (1)
time of procedure
Time it takes to use device
Measured: immediately
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2017
- Study startOct 2012
- Primary completionOct 2012
- Study completionOct 2012
Why it stopped: Lack of enrollment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Wounds and InjuriesStudies 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
- 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
- Brian M Parret, MD, Principal investigator, Plastic Surgery Institute of Northern CaliforniaLandon Clark, MD,MPH, Principal investigator, Palo Alto Medical FoundationStanley P Leong, MD,FACS, Principal investigator, California Pacific Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03201536
- Sponsor's protocol ID
- 100-002-12
- Acronym
- ZIPS3
- Status last verified
- Jun 2017
- First submitted
- 21 May 2012
- Last updated
- 28 Jun 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ZipLine Incision Approzimation Vs. Suture:Zips3 Physician Preference Study
- ClinicalTrials.gov ID
- NCT03201536
- Acronym / sponsor ID
- ZIPS3 / 100-002-12
- Conditions
- Wounds and Injuries
- Keywords
- ZipLine3 device vs. conventional sutures
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Lack of enrollment
- Enrolment
- 0 participants (actual)
- Lead sponsor
- ZipLine Medical Inc.Industry (pharma, biotech, devices)
- Study start
- Oct 2012
- Primary completion
- Oct 2012 (actual)
- Study completion
- Oct 2012 (actual)
- First posted
- 28 Jun 2017 (actual)
- 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.
Zipline incision approximation vs. Suture -- zips 3 study. A prospective, multi-site, non-blinded, randomized controlled, study designed to evaluate user preferences associated with use of the zipline 3 system versus conventional suturing for incision closure.
Detailed description
The objective of this study is to evaluate user preferences associated with the ZipLine 3 system versus conventional suture placement.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| sutures | Active comparator | Device: conventional SuturezipLine3 device verses conventional sutures |
| Zip3 Device | Active comparator | Device: Zip3 |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Patients between 18 and 75 years of age
- Patient requiring a non-emergent skin incision or biopsy
Key exclusion criteria (11 listed)
- Facial Incisions or incisions in high stress or tension areas
- Previously diagnosed peripheral vascular disease
- Insulin-dependent diabetes mellitus
- Known bleeding diathesis
- Known personal or family history of keloid formation or scar hypertrophy
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 |
|---|---|---|
| conventional SutureAlso: stitches,PeriStripsSutures | Device | sutures |
| Zip3wound closure device | Device | Zip3 Device |
Primary outcome
Wound healing
Time frame: 3-month
Wound healing as judged by the CVAS (Cosmetic Visual Analogue Scale) wound healing scale
1 secondary outcome
time of procedure
Time frame: immediately
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 28 Jun 2017.
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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.
Brian M Parret, MD principal investigator
Plastic Surgery Institute of Northern California
Landon Clark, MD,MPH principal investigator
Palo Alto Medical Foundation
Stanley P Leong, MD,FACS principal investigator
California Pacific Medical Center
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing conventional Suture and Zip3 in people with Wounds and Injuries, run by ZipLine Medical Inc. at 3 sites 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 7 inclusion and 11 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 28 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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?
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?
Wound healing (time frame: 3-month). 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 28 Jun 2017.