In-Vitro and Clinical Testing
OptMed performed extensive in vitro and in vivo animal studies in accordance with the FDA guidance on topical skin adhesives and with the requirements of ISO 10993 "Biological Evaluation of Medical Devices."
OptMed has conducted extensive in-vitro and in-vivo animal studies to demonstrate equivalence of its topical skin adhesive BondEase™ (now rebranded as SpectrumEX™) with cyanoacrylate-based skin adhesives on the market. Above: Porcine skin model.
BondEase® Topical Skin Adhesive was evaluated in a prospective, randomized clinical study compared to conventional wound closure devices in the same manner as Dermabond®, our predicate device. Types of wounds included traumatic lacerations and surgical incisions with and without deep dermal sutures.
PATIENTS WERE TREATED
PATIENTS RECEIVING BONDEASE®
PATIENTS RECEIVING CONVENTIONAL WOUND CLOSURE DEVICES (SUTURES)
1. The primary endpoint of the study was the incidence of 100% apposition of wound edges 10 days after wound closure which showed that BondEase® 100% closure rate was 77.1% versus 80.4 % for the conventional wound closure devices (CWCD) group.
2. The secondary efficacy endpoint was the incidence of wounds with an optimal cosmetic outcome at 28 days; the results for cosmesis showed that the proportion of subjects treated with BondEase® had an optimal cosmetic outcome that was 5% greater than that of the CWCD group.
The use of BondEase® is equivalent to sutures
Investigators found that the use of BondEase® was either good or excellent for all performance categories in nearly all subjects.
The use of BondEase® is safe for the closure of traumatic lacerations and surgical incisions.
There were no infections at the study wound site or signs of infection with BondEase®.
The signs of inflammation reported with BondEase® were minimal
SpectrumEX™ (formerly known as BondEase®) topical skin adhesive is positioned to deliver solid and reliable performance
SPEED AND COVERAGE
Fast drying time
High flexibility on skin
COMFORT & CONTROL
Great control of application