The self-assembling peptide barrier T45K (SAPB-T45K) is an oligopeptide that rapidly forms a biocompatible hemostatic barrier when applied to wounds.
Evaluate safety and performance of SAPB-T45K in cutaneous surgery.
In this single-blind study, after sequential shave excision of 2 lesions, wounds were randomized (intrapatient) to SAPB-T45K or control treatment. Safety was assessed at treatment, Day 7, and Day 30. Performance was evaluated using time to hemostasis (TTH) and ASEPSIS wound scores, with a subgroup analysis for patients with or without antiplatelet therapy.
Each of 46 patients (10 [22%] with antiplatelet therapy) received randomized SAPB-T45K or control treatment for 2 wounds. Safety assessments were similar, and ASEPSIS scores reflected normal healing in both wound groups. SAPB-T45K demonstrated significantly faster median TTH (24.5 [range, 7–165] seconds) compared with control (44 [10–387] seconds), for a 41% median TTH reduction (18 [95% confidence interval, 7–35] seconds, p < .001). SAPB-T45K provided an identical median TTH of 24 seconds, regardless of antiplatelet therapy. Control median TTH was 90 and 40 seconds for patients taking or not taking antiplatelet therapy, respectively.
SAPB-T45K provided significantly faster median TTH versus control, especially with antiplatelet therapy, and safety profiles were similar.
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*Department of Plastic and Reconstructive Surgery, Galway University Hospitals, Galway, Republic of Ireland;
†Arch Therapeutics, Inc., Framingham, MA;
‡HRB Clinical Research Facility, National University of Ireland, Galway, Republic of Ireland;
§Galway University Hospital, Galway, Republic of Ireland
Address correspondence and reprint requests to: Jack Kelly, MB, MD, FRCS (Plast), Galway University Hospital, Newcastle Road, Galway, Ireland H91 YR71, or e-mail: firstname.lastname@example.org
This study was sponsored by Arch Therapeutics, Inc., with partial funding from Science Foundation Ireland.
J. Kelly was Principal Investigator for the AC5-1 study and has been a Scientific Advisor for Arch Therapeutics, J. Woods and G. Rahmani were study investigators, and V. McInerney was the study manager. T. Norchi, S. Kates, and J. Prats are employees of Arch Therapeutics, Inc., and may own equity in the company.
Clinicaltrials.gov identifier: NCT02704104.