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.
“Lacerations represent a large portion of injuries presenting to the emergency department and can be a significant time and cost burden,” said Pia Malmquist, M.D., 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.”
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.
“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.”
ZipLine Medical develops cost-effective, non-invasive wound closure products that address the need for better clinical outcomes and reduction in overall healthcare cost. Zip Surgical Skin Closure devices have been used in more than 600,000 cases and in over 30 countries worldwide. The PreLoc Wound Closure provides non-invasive, delayed primary closure for chronic and hard-to-close wounds such as diabetic ulcers and dehisced incisions. The award-winning ZipStitch laceration kit offers consumers a hospital-grade wound closure at home or in the field. ZipLine Medical was founded by Amir Belson, Md., and is headquartered in Campbell, Calif.