WoundZIPSNCT02213510

ZIPS Study - Zip Incision aPproximation vs. Suture

A study testing Zip Surgical Skin Closure Device and Standard Suture Closure in people with Wound and Cardiac Arrhythmia, run by University of California, San Diego at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Wound, Cardiac Arrhythmia
What is being tested?: Zip Surgical Skin Closure Device and Standard Suture Closure
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 40 participants
Where: 1 siteUnited States
Study dates: Aug 2014to Jun 2015
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
No healthy volunteers
Adult, Older adult

Who may be able to join

Patients 18 years of age and older;
Patients requiring suture closure for epidermal closure (after placement of cardiac implantable electronic devices; including de novo and re implant generator changes);
Patients willing and able to complete study protocol
Life expectancy greater than 1 year

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 subject unsuitable for this study.
Pregnancy

Trial locations and contacts

1 site in 1 country.

United States1 site

UCSD Sulpizio Cardiovascular Center
La Jolla, California, 92037

Other trials in United States

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 Versus Conventional Sutures for Skin Closure in Subjects Who Undergo a CIED Procedure.

ZipLine Medical, Inc. has developed a novel, non-invasive skin closure device called "Zip Surgical Skin Closure" to replace sutures, staples and glue for closure of the skin layer for surgical incisions or laceration repair. The study will be comparing the Zip Surgical Skin Closure to standard sutures in patients undergoing cardiovascular implantable electronic device (CIED) procedures on outcomes including closure time, cosmetic appearance of resulting scar, and overall cosmetic appearance of scar. The study will be following participants for 3 months following CIED procedure.

Read the detailed description

ZipLine Medical, Inc. has developed a novel, non-invasive skin closure device called "Zip Surgical Skin Closure" to replace sutures, staples and glue for closure of the skin layer for surgical incisions or laceration repair. The device is designed to provide closure speed superior to sutures, while resulting in a suture-like cosmetic outcome.The ZIPS study is a randomized, clinical trial comparing outcomes of procedures that use the Zip Surgical Skin Closure device with the outcomes of procedures that use stitches. The Zip Surgical Skin Closure is not an investigational device and is currently used in hospital across the United States. The Zip Surgical Skin Closure is a non-invasive (in other words, does not pierce the skin or enter into the wound) device to hold skin closed while healing can occur. It adheres to the skin close to the incision and uses adjustable straps to hold the incision closed. It is typically worn on the skin for 7-14 days and is removed by peeling from the skin. Patients will be randomized to either Zip Surgical Skin Closure or sutures, in addition to dissolvable sutures for the deeper layers, for surgical procedures for cardiovascular implantable electronic devices (CIED) i.e. pacemakers or defibrillators. Both of these closure techniques are considered standard of care at this facility and are not themselves experimental. However, the goal of this experimental study is to see if there are any significant differences between the two closure methods, in a controlled study environment.

Since the Zip Surgical Skin Closure device is relatively new to the market, there is a limited amount of information available describing the experience of patients and doctors using the device. In this study, the investigators will be looking to compare the Zip Surgical Skin Closure and stitches methods for the time necessary for the surgeon to close the incision, cosmetic appearance of the resulting scar, and satisfaction of you and your surgeon. The investigators will also be monitoring both study groups for occurrence of any adverse (unfavorable) events. Patients will be followed for a total of 3 months for this study. All study visits align with standard of care follow up for post-implantation of CIED. Non-identifiable pictures will be obtained of the scar during follow up and both patients and surgeons will complete questionnaires indicating their experience and satisfaction with the either skin closure method.

Conditions: Wound, Cardiac Arrhythmia
Being tested: Zip Surgical Skin Closure Device, Standard Suture Closure
Keywords: pacemaker, implantable cardioverter defibrillator, ICD, surgical wound closure, sutures, Zipline, Zips, CIED, cardiovascular implantable electronic devices, arrhythmia
Medical subject headings: Wounds and Injuries, Arrhythmias, Cardiac

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Zip Surgical Skin Closure DeviceDevice
Also called Wound closure device
The Zip Surgical Skin Closure device is a single use, sterile medical device that replaces sutures, staples, and glue for closure of the skin layer for surgical incisions or laceration repair. The device will applied by the surgeon at the end of the CIED procedure and be worn until the two week post-operative wound check.
Standard Suture ClosureDevice
The surgeon will perform standard suture closure for the skin layer following CIED procedure.

Study groups in NCT02213510
Study group	Role	What they receive
Zip Surgical Skin Closure device	Experimental	The Zip Surgical Skin Closure device is a single use, sterile medical device that replaces sutures, staples, and glue for closure of the skin layer for surgical incisions or laceration repair. The device will applied by the surgeon at the end of the CIED procedure and be worn until the two week post-operative wound check. Receives: Device: Zip Surgical Skin Closure Device
Standard Suture Closure	Active comparator	The surgeon will perform standard suture closure for the skin layer following CIED procedure. Receives: Device: Standard Suture Closure

What is being measured

The primary outcome is the main question the study is designed to answer.

Overall Closure Time
Duration of time starting when suture needle (control) or Zip device touches the skin until final suture knot is cut or Zip device application is complete (e.g., top liner is removed.)
Measured: 2 weeks
Wound Healing as Determined by the CVAS (Cosmetic Visual Analogue Scale)
Based on photographs taken of scars taken at 3 months following CIED procedure. The CVAS scale is measured from 0mm (representing best scar) to 100 mm (representing worst scar).
Measured: 3 Months

Secondary outcomes (9)

Surgeon Wound Evaluation Scale (WES)
At 2 weeks post-procedure, the Wound Evaluation Scale was measured. The scale is based from 0 (representing normal skin) to 100 (representing a poor scar).
Measured: 2 weeks
Surgeon Evaluation Based on the Wound Evaluation Scale (WES)
The surgeon will complete an assessment of the following:
1. Closure Method Satisfaction
2. Scar Satisfaction
3. Wound Healing as judged by Wound Evaluation Scale
Scale rated on 1 (least favorable) to 6 (most favorable)
Please note that only 18 patients were evaluated (of 19) in the Standard Suture Closure due to one patient withdrawing from the trial.
Measured: 3 Months
Surgeon Satisfaction With Scar
At 3 months post-procedure, the surgeon evaluated their satisfaction on a scale from 1 to 5, 5 being the least favorable.
Please note that only 18 patients were evaluated (of 19) in the Standard Suture Closure due to one patient withdrawing from the trial.
Measured: 3 months
Patient Comfort
At 2 weeks post-procedure, patient comfort was evaluated with a scale 1 (most favorable) to 5 (least favorable).
Measured: 2 weeks
Patient Satisfaction With Scar
Patient will complete questionnaires that includes assessments of the following:
1. Pain
2. Closure Method Comfort
3. Closure Method Satisfaction
4. Scar Satisfaction
Scar Satisfaction was measured on a scale from 1 (most satisfied) to 5 (least satisfied)
Please note that only 18 patients were evaluated (of 19) in the Standard Suture Closure due to one patient withdrawing from the trial.
Measured: 3 months
Patient Rating of Scar
At 3 months post-procedure, patients were asked to rate their scar. Scale was measured from 0 (best scar) - 10 (worst scar)
Please note that only 18 patients were evaluated (of 19) in the Standard Suture Closure due to one patient withdrawing from the trial.
Measured: 3 months
Patient Incision Pain
At the discharge visit, patients evaluated their level of pain at the incision site based on a scale 1 (least pain) through 10 (worst pain).
Measured: 1 day (discharge)
Patient Incision Pain
At 2 week post-procedure, incision pain was evaluated on a scale 0 to 10 (worst pain).
Measured: 2 weeks
Patient Incision Pain
Incision pain experienced by the patient was evaluated at 3 months post-procedure. This was evaluated on a scale of 0 (least pain) to 10 (worst pain).
Measured: 3 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Aug 2014Jun 2015

First posted11 Aug 2014 (estimated)
Study startAug 2014
Primary completionJun 2015
Study completionJun 2015

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 WoundStudies 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
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 40 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02213510
Sponsor's protocol ID: 140718
Acronym: ZIPS
Status last verified: May 2016
First submitted: 7 Aug 2014
Last updated: 30 May 2016
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 30 May 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 Versus Conventional Sutures for Skin Closure in Subjects Who Undergo a CIED Procedure.
ClinicalTrials.gov ID: NCT02213510
Acronym / sponsor ID: ZIPS / 140718
Conditions: Wound, Cardiac Arrhythmia
Keywords: pacemaker, implantable cardioverter defibrillator, ICD, surgical wound closure, sutures, Zipline, Zips, CIED
Study type: Interventional
Recruitment status: Completed
Enrolment: 40 participants (actual)
Lead sponsor: University of California, San DiegoUniversity, hospital or other
Collaborators: ZipLine Medical Inc.
Study start: Aug 2014
Primary completion: Jun 2015 (actual)
Study completion: Jun 2015 (actual)
First posted: 11 Aug 2014 (estimated)
Results: Posted 30 May 2016

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

ZipLine Medical, Inc. has developed a novel, non-invasive skin closure device called "Zip Surgical Skin Closure" to replace sutures, staples and glue for closure of the skin layer for surgical incisions or laceration repair. The study will be comparing the Zip Surgical Skin Closure to standard sutures in patients undergoing cardiovascular implantable electronic device (CIED) procedures on outcomes including closure time, cosmetic appearance of resulting scar, and overall cosmetic appearance of scar. The study will be following participants for 3 months following CIED procedure.

Detailed description

ZipLine Medical, Inc. has developed a novel, non-invasive skin closure device called "Zip Surgical Skin Closure" to replace sutures, staples and glue for closure of the skin layer for surgical incisions or laceration repair. The device is designed to provide closure speed superior to sutures, while resulting in a suture-like cosmetic outcome.The ZIPS study is a randomized, clinical trial comparing outcomes of procedures that use the Zip Surgical Skin Closure device with the outcomes of procedures that use stitches. The Zip Surgical Skin Closure is not an investigational device and is currently used in hospital across the United States. The Zip Surgical Skin Closure is a non-invasive (in other words, does not pierce the skin or enter into the wound) device to hold skin closed while healing can occur. It adheres to the skin close to the incision and uses adjustable straps to hold the incision closed. It is typically worn on the skin for 7-14 days and is removed by peeling from the skin. Patients will be randomized to either Zip Surgical Skin Closure or sutures, in addition to dissolvable sutures for the deeper layers, for surgical procedures for cardiovascular implantable electronic devices (CIED) i.e. pacemakers or defibrillators. Both of these closure techniques are considered standard of care at this facility and are not themselves experimental. However, the goal of this experimental study is to see if there are any significant differences between the two closure methods, in a controlled study environment.

Study design

Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Zip Surgical Skin Closure device	Experimental	Device: Zip Surgical Skin Closure DeviceThe Zip Surgical Skin Closure device is a single use, sterile medical device that replaces sutures, staples, and glue for closure of the skin layer for surgical incisions or laceration repair. The device will applied by the surgeon at the end of the CIED procedure and be worn until the two week post-operative wound check.
Standard Suture Closure	Active comparator	Device: Standard Suture ClosureThe surgeon will perform standard suture closure for the skin layer following CIED procedure.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

Patients 18 years of age and older;
Patients requiring suture closure for epidermal closure (after placement of cardiac implantable electronic devices; including de novo and re implant generator changes);
Patients willing and able to complete study protocol
Life expectancy greater than 1 year

Key exclusion criteria (7 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 Closure DeviceAlso: Wound closure deviceThe Zip Surgical Skin Closure device is a single use, sterile medical device that replaces sutures, staples, and glue for closure of the skin layer for surgical incisions or laceration repair. The device will applied by the surgeon at the end of the CIED procedure and be worn until the two week post-operative wound check.	Device	Zip Surgical Skin Closure device
Standard Suture ClosureThe surgeon will perform standard suture closure for the skin layer following CIED procedure.	Device	Standard Suture Closure

Primary outcome

Overall Closure Time
Time frame: 2 weeks
Duration of time starting when suture needle (control) or Zip device touches the skin until final suture knot is cut or Zip device application is complete (e.g., top liner is removed.)
Wound Healing as Determined by the CVAS (Cosmetic Visual Analogue Scale)
Time frame: 3 Months
Based on photographs taken of scars taken at 3 months following CIED procedure. The CVAS scale is measured from 0mm (representing best scar) to 100 mm (representing worst scar).

9 secondary outcomes

Surgeon Wound Evaluation Scale (WES)
Time frame: 2 weeks
Surgeon Evaluation Based on the Wound Evaluation Scale (WES)
Time frame: 3 Months
Surgeon Satisfaction With Scar
Time frame: 3 months
Patient Comfort
Time frame: 2 weeks
Patient Satisfaction With Scar
Time frame: 3 months
Patient Rating of Scar
Time frame: 3 months
Patient Incision Pain
Time frame: 1 day (discharge)
Patient Incision Pain
Time frame: 2 weeks
Patient Incision Pain
Time frame: 3 months

Results and safety

Results posted to the registry on 30 May 2016, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Zip Surgical Skin Closure Device	21	20
Standard Suture Closure	19	18

Primary outcome: Overall Closure Time

Time frame: 2 weeks. Mean (Standard Deviation). Unit: seconds

Measure	Zip Surgical Skin Closure Device n = 21	Standard Suture Closure n = 19
Value	78 (30.36)	216 (93.71)

Zip Surgical Skin Closure Device vs Standard Suture Closure: p <0.001, t-test, 2 sided

Primary outcome: Wound Healing as Determined by the CVAS (Cosmetic Visual Analogue Scale)

Time frame: 3 Months. Mean (Standard Deviation). Unit: mm

Measure	Zip Surgical Skin Closure Device n = 21	Standard Suture Closure n = 18
Value	35.8 (40.6)	40.6 (21.7)

Zip Surgical Skin Closure Device vs Standard Suture Closure: p = 0.655, t-test, 2 sided

Population analysed: Please note that only 18 patients were evaluated (of 19) in the Standard Suture Closure due to one patient withdrawing from the trial.

9 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Zip Surgical Skin Closure Device	0 of 21 (0%)	0 of 21 (0%)	Not reported
Standard Suture Closure	0 of 19 (0%)	0 of 19 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 30 May 2016.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
ZipLine Medical WebsiteLink provided by the sponsor.

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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.

Ulrika Birgersdotter-Green, MD principal investigator

University of California, San Diego

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 Device and Standard Suture Closure in people with Wound and Cardiac Arrhythmia, run by University of California, San Diego 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 4 inclusion and 7 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 30 May 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.

Are results available for this study?

Yes. Results are posted in the registry (first posted 30 May 2016). 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?

Overall Closure Time (time frame: 2 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02213510.

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 30 May 2016.