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

Abstract

Background: The self-assembling peptide barrier T45K (SAPB-T45K) is an oligopeptide that rapidly forms a biocompatible hemostatic barrier when applied to wounds.

Objective: Evaluate safety and performance of SAPB-T45K in cutaneous surgery.

Materials and methods: 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.

Results: 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.

Conclusions: SAPB-T45K provided significantly faster median TTH versus control, especially with antiplatelet therapy, and safety profiles were similar.

Figures

Figure 1.

Appearance of gelled SAPB-T45K after contact with charged surface.

Figure 2.

Cryo–scanning electron micrograph (SEM) of self-assembled nanofiber network. SAPB-T45K was freshly prepared with deionized water and thoroughly mixed to obtain a clear solution, which was further diluted 1:1 in phosphate buffered saline. The sample (30 µL) was kept at room temperature for 4 hours and then flash-frozen with liquid nitrogen before loading in the cryo-SEM sample holder. The cryo-SEM instrument was cooled to −190°C. Water was sublimed from the sample at −80°C for 2 hours, then the sample was platinum coated for 15 seconds before examination. Spherical objects are artifacts, not SAPB-T45K.

Figure 3.

Study schematic.

Figure 4.

Representative SAPB-T45K- and control-treated wounds from 1 patient: (1) SAPB-T45K-treated (right mid-back, 1.5 cm2) and (2) control-treated wounds (left lower back, 2.0 cm2) at the time of treatment (A), Day 7 (B), and Day 30 (C).