Clinical Data

Healing of a Complex Surgical Wound using a Novel Self-Assembling Peptide-based Advanced Wound Dressing (poster #CS-027)

Dan Kapp, MD (Chief of Surgery, Palm Beach Gardens Medical Center) and Terrence Norchi, MD (Arch Therapeutics)

Presented at SAWC Fall Virtual 2020 in November 2020

Conclusion: AC5 Advanced Wound System, a novel self-assembling peptide-based advanced wound dressing, quickly restarted the previously stalled healing process in this complex surgical wound. The results indicate that the use of this dressing may obviate the need for continued costly treatments and procedures, thus reducing the total cost of lower extremity wound care, while improving patient’s quality of life.

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Healing of a Chronic Refractory Burn Wound with a Novel Self-Assembling Peptide-based Advanced Wound Dressing (poster #CS-026)

Randall Wolcott, MD (Wound & Burn Specialist, Southwest Regional Wound Care Center) and Kalpana Kamath, PhD (Arch Therapeutics)

Presented at SAWC Fall Virtual 2020 in November 2020

Conclusion: The aggressive debridement made possible by the application of AC5 Advanced Wound System, the novel self-assembling peptide-based advanced dressing, facilitated the removal of the infected granulation tissue. This reduction in the wound bioburden likely helped address one of the major stimuli contributing to the chronicity and severity of these types of wounds. Subsequently, the advanced wound dressing appears to have not only enabled accelerated healing of this stalled refractory burn wound, but it also provided a marked improvement in the patient’s quality-of-life.

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Enabling Aggressive Surgical Debridement and Healing in a 10-year-old Decubitus Ulcer with a Novel Self-Assembling Peptide-based Advanced Wound Dressing (poster #CS-022)

Randall Wolcott, MD (Wound & Burn Specialist, Southwest Regional Wound Care Center, Terrence Norchi, MD (Arch Therapeutics) and Daniel Wadsworth (Arch Therapeutics)

Presented at SAWC Fall Virtual 2020 in November 2020

Conclusion: Concomitant use of debridement and the novel self-assembling peptide-based AC5 Advanced Wound System, which formed a clear conforming dressing over the wound surface, allowed for a more aggressive procedure with bleeding control in a low acuity clinic setting and without the need for thrombin or sutures. In addition, the nanofiber network appeared to cohesively seal the wound bed surface after debridement made the wound devoid of biofilm and senescent host cells. The resulting scaffold allowed for the adhesion, migration, and proliferation of healthy host cells and favorable wound healing outcomes.

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Self-Assembling Peptide Barrier Hemostatic Device

The tested device is known as AC5 Advanced Wound System in the USA and AC5 Topical Hemostat in Europe, respectively, where it has received marketing authorizations.)

Randomized, blinded safety study of 46 patients undergoing cutaneous surgery, including 10 patients on antiplatelet therapy (blood thinner). Each patient underwent shave excision of 2 lesions, which were randomized to AC5® or control treatment.

AC5® met the primary safety and secondary performance endpoints

  • Safety profiles similar between AC5®- and control-treated wounds (30-day follow up)
  • No serious adverse effects noted
  • 41% statistically significant improvement in median time to hemostasis (TTH) with AC5® vs control
  • TTH ≤30 seconds in groups of AC5®-treated wounds (+/- antiplatelet therapy)

Rahmani G et al. Dermatol Surg. 2018;44:939–948.

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