ZIPS Study - Zip Incision aPproximation vs. Suture

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.