October 10, 2016 — ZipLine Medical Inc. recently announced results from a study recently published online in Pacing and Clinical Electrophysiology (PACE) showing significant efficiencies when Zip Surgical Skin Closure is used following cardiac implantable electronic device (CIED) implantation. The Zip also demonstrated greater uniformity in closure technique, with no compromise in cosmetic outcomes or patient safety.
The paper reports on the first randomized, controlled, prospective study of the Zip in CIED implantation in 40 patients. In the study, the Zip demonstrated significantly shorter overall closure time (78 ± 6.6 versus 216 ± 21.5 sec.; p < 0.001) and average incision closure time per cm (18 ± 2 versus 50.1 ± 6.7 sec/cm; p < 0.001), with less variance (standard error 2.08 versus 6.72, p < 0.001) when compared to absorbable running subcuticular sutures. Scar cosmesis was equivalent to suturing, and neither group experienced a closure-related adverse event. The article is entitled “Cardiac Device Implant Skin Closure with a Novel Adjustable, Coaptive Tape-Based Device.”
“The significant time savings and reduced variability associated with the Zip device may also improve overall procedure cost and scheduling efficiency,” said Ulrika Birgersdotter-Green, M.D., director, pacemaker and ICD services for the University of California, San Diego School of Medicine and the study’s principal investigator. “Because the device eliminates suturing for the skin closure, this task may potentially be delegated from the operator to further improve workflow efficiency in the procedure lab.”
According to the PACE study authors, closure of the superficial skin layer of surgical incisions has traditionally relied on methods that puncture intact, healthy tissue or introduce a foreign body that is gradually absorbed by the patient’s body. Additionally, suturing requires considerable training and practice, with relatively high inter-surgeon variability for both closure speed and cosmetic outcome. Metal skin staples have been shown to provide a similar time savings versus sutures, but at the cost of puncture scars, increased patient pain and infection risk from additional skin punctures.
The Zip is a non-invasive and easy-to-use device providing protected, secure and well-approximated wound closure with uniformly distributed force along the length of the incision. Clinicians can adjust the tension of the device at any time peri- or post-procedure. Because closure and removal are simple, clinicians can delegate the task to a physician assistant or nurse, and patients may remove it at home, if appropriate. The flexible design is not only comfortable for patients, but often enables them to make quicker progress in their recovery. Because there are no skin punctures with the Zip, scarring is minimal and there are no added channels for infection to enter.
Zip Surgical Skin Closure devices are classified by the U.S. Food and Drug Administration (FDA) as Class I, 510(k) Exempt and have received the CE Mark.
For more information: www.ziplinemedical.com