Hemastyl(™) Wound Dressing

Hemastyl Wound Dressing is an amorphous hydrogel wound dressing containing silver chloride, cupric chloride, and ferric chloride as preservatives, along with hyaluronic acid and fish collagen. It is indicated for management of various wounds including burns, ulcers, lacerations, and surgical sites under prescription, and for minor cuts and abrasions over-the-counter.

The device uses a hydrogel gel composition with proprietary stabilized silver salt as a preservative during shelf life, incorporating silver, copper, and iron ions for antimicrobial action. It maintains a moist wound environment, provides moisture-donating and moisture-sequestering action depending on wound moisture level, and requires dressing changes within 24 hours.

ISO 10993-1 (Biological Evaluation of Medical Devices Part 1), BS EN ISO 10993-1, USP <51> (Antimicrobial Effectiveness Testing), and NIH Publication 99-4494 for biocompatibility and preservative assurance testing.

Hemastyl is substantially equivalent to the predicate AcryDerm Antimicrobial Silver Gel Wound Dressing Model #B because both devices are hydrogels with identical indications for use, same prescription/OTC status, comparable mechanisms using stabilized silver salt preservation, biocompatible non-sterile formulations, and equivalent moisture management principles. A porcine wound healing study showed no statistically significant differences in wound closure rates between the devices.