ZipLine Medical, Inc. tells us about positive results from a randomized, prospective clinical study comparing Zip® surgical skin closure with sutures for lacerations.
Conducted at the Karolinska University Hospital in Stockholm, Sweden the study demonstrated both clinical and economic benefits of the Zip® Surgical Skin Closure device when used in an emergency medicine setting for lacerations. A poster presenting these results was presented at the Swedish Emergency Medicine Talks conference in Stockholm, Sweden from March 13 to 15. The poster was selected to receive the Best Poster Award.
In the study, 13 pediatric and 13 adult patients presenting to the emergency department with a laceration were randomized to receive Zip Surgical Skin Closure or nylon sutures for laceration closure. The primary outcome was total procedure time, with patient pain as a secondary outcome, both measured using the Visual Analog Scale. Patient satisfaction, pain and adverse events were recorded via phone interview 10 and 30 days post-treatment.
Average total treatment time in the pediatric and adult cohorts using Zip closure was reduced by 59 percent (p=0.004) and 62 percent (p=0.010), respectively, when compared to sutures. All patients reported 69 percent less pain during closure (mean VAS 12.8 and 40.9, respectively), 31 percent less pain during closure removal, and 54 percent less pain when assessing overall scar pain (mean VAS 9.7 and 20.8, respectively) with the Zip device versus sutures. Patients treated with the Zip device reported 66 percent less fear or anxiety during wound closure compared to sutures (mean VAS 11.8 and 34.6, respectively). In addition to procedure time savings, the majority of patients receiving the Zip device removed the device at home, while the suture cohort required an additional visit to a local primary care provider for suture removal.
In addition to the surgery-focused Zip device used for the study, ZipLine Medical, Inc. is seeing significant growth in sales of the ZipStitch™ Laceration Kit, which is based on the same technology as the surgical Zip device. It is optimized for, and sold directly to, consumers for at-home or on-the-go treatment of minor cuts and lacerations.
“Lacerations represent a large portion of injuries presenting to the emergency department and can be a significant time and cost burden,” said Pia Malmquist, MD, Principal Investigator of the study and Function Unit Manager of the Pediatric Emergency Ward, Karolinska University Hospital. “Our study results with the Zip device for both pediatric and adult lacerations demonstrated a promising solution for reducing procedure time and healthcare cost, while improving patient satisfaction.”
“We are also seeing significant interest in ZipStitch from the utility and construction industries, as they see this as a better way to treat minor on-the-job injuries compared to what they currently carry in their field first aid kits,” said John Tighe, President and CEO of ZipLine Medical. “The ZipStitch Laceration Kit has all you need to close and cover a minor cut or laceration, whether it occurs at home, at play or on the job.”
Source: ZipLine Medical, Inc.