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ZIPS Study - Zip Incision aPproximation vs. Suture

NCT ID: NCT02213510

Last Updated: 2016-05-30

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-08-31

Study Completion Date

2015-06-30

Brief Summary

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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

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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

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Wound Cardiac Arrhythmia

Keywords

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pacemaker implantable cardioverter defibrillator ICD surgical wound closure sutures Zipline Zips CIED cardiovascular implantable electronic devices arrhythmia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

NONE

Study Groups

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Zip Surgical Skin 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.

Group Type EXPERIMENTAL

Zip Surgical Skin Closure Device

Intervention Type 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 Closure

The surgeon will perform standard suture closure for the skin layer following CIED procedure.

Group Type ACTIVE_COMPARATOR

Standard Suture Closure

Intervention Type DEVICE

The surgeon will perform standard suture closure for the skin layer following CIED procedure.

Interventions

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Zip Surgical Skin 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.

Intervention Type DEVICE

Standard Suture Closure

The surgeon will perform standard suture closure for the skin layer following CIED procedure.

Intervention Type DEVICE

Other Intervention Names

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Wound closure device

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

1. Known bleeding disorder not caused by medication;
2. Known personal or family history of keloid formation or scar hypertrophy;
3. Known allergy or hypersensitivity to non-latex skin adhesives;
4. Atrophic skin deemed clinically prone to blistering;
5. Any skin disorder affecting wound healing;
6. Any other condition that in the opinion of the investigator would make a particular subject unsuitable for this study.
7. Pregnancy
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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ZipLine Medical Inc.

INDUSTRY

Sponsor Role collaborator

University of California, San Diego

OTHER

Sponsor Role lead

Responsible Party

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Ulrika Birgersdotter-Green

Clinical Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ulrika Birgersdotter-Green, MD

Role: PRINCIPAL_INVESTIGATOR

University of California, San Diego

Locations

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UCSD Sulpizio Cardiovascular Center

La Jolla, California, United States

Site Status

Countries

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United States

Related Links

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http://www.ziplinemedical.com/

ZipLine Medical Website

Other Identifiers

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140718

Identifier Type: -

Identifier Source: org_study_id