First Safety and Performance Evaluation of T45K, a Self-Assembling Peptide Barrier Hemostatic Device, After Skin Lesion Excision

Abstract

BACKGROUNDThe self-assembling peptide barrier T45K (SAPB-T45K) is an oligopeptide that rapidly forms a biocompatible hemostatic barrier when applied to wounds.OBJECTIVEEvaluate safety and performance of SAPB-T45K in cutaneous surgery.MATERIALS AND METHODSIn 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.RESULTSEach 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.CONCLUSIONSSAPB-T45K provided significantly faster median TTH versus control, especially with antiplatelet therapy, and safety profiles were similar.

Multifunctional Self-Assembled Peptide Hydrogels for Biomedical Applications

“…Bleeding small blood vessels in cardiac surgery RADA16 Hemostatic agent [323] SAPB-T45K Skin lesion excision T45K Hemostatic agent+ Faster wound healing [324] Purastat Endoscopic submucosal dissection RADA16 Hemostatic agent [325] PuraMatrix Peritoneal effusion RADA16 Hemostatic agent+ Faster wound healing [326] Funding: This research received no external funding.…”

Synthetic extracellular matrices with function-encoding peptides

“…Similarly, a chiral version of EAK16 (Sciobio) is used to treat severe bedsore and chronic diabetic ulcers, and to promote wound healing 216 . Other peptide-based systems that have been tested in clinical trials are available on the market, including the mineralizing peptide P11-4 (Curolox) for the treatment of dental caries 217 , and T45K (AC5) 218 for haemostatic control in patients undergoing antiplatelet therapy. Of note, clinical trials investigating peptide hydrogels are currently mainly focused on the treatment of dental caries, tooth diseases, haemorrhages and skin diseases.…”

Self-assembling peptide scaffolds in the clinic

“…Later on, in a prospective, randomized clinical trial, the same SAP was demonstrated to be effective, and significantly better than standard treatments, in regenerating decayed enamel, favoring the formation of novel hydroxyapatite at the bottom of early carious lesions 42 . Recently, another SAP, named T45K, was tested for safety and efficacy as hemostat solution for small-size skin wounds in a blind clinical trial 43 . Authors showed that with T45K, if compared to control treatment, a faster time to hemostasis and superior wound healing could be achieved also in patients undergoing antiplatelet therapy.…”