A Single-Arm, Prospective Study of a Proprietary Synthetic Acellular Self-Assembling Peptide Wound Matrix, AC5® Advanced Wound System, for Treatment of Hard-to-Heal Wounds.

Abstract

Introduction: When wounds do not respond to standard treatments, advanced therapies are recommended. One such therapy, a proprietary synthetic peptide, self-assembles into a wound matrix when applied to a wound to provide a physical-mechanical barrier that mitigates contamination, modulates inflammation, and becomes a scaffold for cell proliferation and growth. This study evaluated the safety and performance of the AC5 ® Advanced Wound System (Arch Therapeutics Inc. Framingham, Massachusetts) in the management of long-duration, non-healing, and challenging acute and chronic wounds that failed prior therapy.

Materials and methods: Fifteen participants were assigned to receive treatment with AC5 ® weekly or every other week. AC5 ® was evaluated for ease of use, and participants were evaluated for wound condition, healing progress, and local and systemic adverse reactions.

Results: 64% of participants treated weekly had a >50% reduction in wound area at four weeks and 73% had a >60% reduction at eight weeks. For patients treated every other week, 25% achieved 50% wound area reduction at four weeks and 50% had a >50% reduction at eight weeks. The product was easy to apply contiguously to uneven wound geometry. There were no adverse events.

Conclusion: The synthetic self-assembling peptide wound matrix was shown to be safe, effective, and simple to use in the treatment of hard-to-heal wounds. Because AC5® is easy to apply, has an unusual ability to self-assemble into a wound matrix in vivo, and affixes itself contiguously to the interstices of the tissue, AC5 ® may be particularly useful for undermined and tunneled wounds, whether acute or chronic. The results of this study imply that a once-weekly application may result in the best outcome. Further studies are suggested to confirm optimal application frequency for different wound types.