CAMPBELL, Calif. and DALLAS — November 3, 2017 — ZipLine® Medical, Inc. today announced results from the first study to assess Zip® Surgical Skin Closure versus surgical staples for closure in the same patients. Results were presented today as a poster at the American Academy of Hip and Knee Surgery Annual Meeting (AAHKS) by Rodney Benner, MD, of the Shelbourne Knee Center in Indianapolis.
“Zip closure in knee replacement provided some clear benefits in our study,” said Dr. Benner. “Patients reported less pain, improved cosmetic outcomes, and even improved early function by improving range of motion. All in all, Zip closure improved the patient experience, and consequently, I have changed my practice to include Zip closure in all knee arthroplasties.”
The randomized, controlled, prospective study encompassed 25 patients that underwent simultaneous bilateral total knee arthroplasty (TKA), with Zip Surgical Skin Closure used to close one knee and surgical staples to close the other on each patient. Patient follow-up occurred at hospital discharge, two weeks and eight weeks post-operatively.
The study found that:
- 72 percent of patients had greater range of motion on the Zip-closed knee (p = .002), with 44 percent of these patients demonstrating a more than five-degree difference between the Zip-closed and staple-closed knees
- Patients reported less pain on the Zip-closed knee vs. staples at discharge (p = 0.03), at two-week follow-up (p= 0.03), and during device (Zip and staple) removal (p = 0.003)
- Both physicians and patients rated scar quality better on the Zip-closed knee
- 92 percent of patients indicated preference for the Zip vs. staples
The Zip is a non-invasive and easy to use skin closure device that replaces sutures, staples, and glue for surgical incisions and lacerations. Clinical studies have demonstrated significant time savings, fewer wound complications and the ability to reduce post discharge healthcare costs. A patented force distribution design results in secure wound closure, excellent scar quality and high patient satisfaction. Unlike staples or sutures, there are no skin punctures with the Zip that can create pathways for bacteria. Benefits of the Zip have been demonstrated in clinical studies in orthopedic total joint arthroplasty, foot and ankle, pediatric cardiothoracic, electrophysiology, dermatology, and plastic and reconstructive surgery.
ABOUT ZIPLINE MEDICAL
ZipLine Medical is an innovator in cost-effective, non-invasive surgical skin closure devices that deliver high patient satisfaction and surgeon efficiency. Zip Surgical Skin Closure devices have been used in more than 100,000 cases and in over 30 countries worldwide. ZipLine Medical was founded by Amir Belson, M.D. and is headquartered in Campbell, CA. For more information, visit www.ziplinemedical.com.
Zip® Surgical Skin Closure devices are classified by the U.S. FDA as ‘Class I, 510(k) Exempt’ and have received the CE Mark and CFDA approval.