ZIPS Study - Zip Incision aPproximation vs. Suture

Study Overview
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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.

Official Title
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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.

Conditions
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Wound, Cardiac Arrhythmia

Intervention / Treatment
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* Device: Zip Surgical Skin Closure Device
* Device: Standard Suture Closure


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Zip Surgical Skin Closure device<br>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. | Device: Zip Surgical Skin Closure Device<br>* 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.<br>* Other names: Wound closure device;|
| Active Comparator: Standard Suture Closure<br>The surgeon will perform standard suture closure for the skin layer following CIED procedure. | Device: Standard Suture Closure<br>* The surgeon will perform standard suture closure for the skin layer following CIED procedure.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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.) | 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). | 3 Months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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). | 2 weeks | 
| Surgeon Evaluation Based on the Wound Evaluation Scale (WES) | The surgeon will complete an assessment of the following: Closure Method Satisfaction Scar Satisfaction 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. | 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. | 3 months | 
| Patient Comfort | At 2 weeks post-procedure, patient comfort was evaluated with a scale 1 (most favorable) to 5 (least favorable). | 2 weeks | 
| Patient Satisfaction With Scar | Patient will complete questionnaires that includes assessments of the following: Pain Closure Method Comfort Closure Method Satisfaction 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. | 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. | 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). | 1 day (discharge) | 
| Patient Incision Pain | At 2 week post-procedure, incision pain was evaluated on a scale 0 to 10 (worst pain). | 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). | 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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pacemaker, implantable cardioverter defibrillator, ICD, surgical wound closure, sutures, Zipline, Zips, CIED, cardiovascular implantable electronic devices, arrhythmia