ZIPS Study - Zip Incision aPproximation vs. Suture

Cardiac Arrhythmia Clinical Trial

— ZIPS  

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02213510
• Other study ID #: 140718
• Status: Completed
• Phase: N/A
• First received: August 7, 2014
• Last updated: June 17, 2015
• Start date: August 2014
• Est. completion date: June 2015

Study information

• Verified date: June 2015
• Source: University of California, San Diego
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: June 2015
• Est. primary completion date: June 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Arrhythmias, Cardiac
• Cardiac Arrhythmia
• Wound

Intervention

Device:
• 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.
• Standard Suture Closure
The surgeon will perform standard suture closure for the skin layer following CIED procedure.

Locations

Country	Name	City	State
United States	UCSD Sulpizio Cardiovascular Center	La Jolla	California

Sponsors (2)

Lead Sponsor	Collaborator
University of California, San Diego	ZipLine Medical Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time of procedure	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.)	1 day	No
Primary	Wound healing as determined by the CVAS (Cosmetic Visual Analogue Scale)	Based on photographs taken of scars taken at 2 weeks and 3 months following CIED procedure	3 Months	No
Primary	Incidence and severity of adverse events		3 months	Yes
Secondary	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	3 Months	No
Secondary	Patient experience	Patient will complete questionnaires that includes assessments of the following: Pain; Closure Method Comfort; Closure Method Satisfaction; Scar Satisfaction	3 months	No

External Links

•   ZipLine Medical Website