The efficacy of a lysine-based dendritic hydrogel does not differ from those of commercially available tissue sealants and adhesives: an ex vivo study.

BACKGROUND: Hemostatic agents, tissue adhesives and sealants may contribute to a reduction in hemorrhage-associated morbidity and mortality. Towards this end, we have recently developed a lysine-based dendritic hydrogel (PEG-LysNH2) that can potentially be used in the management of severe trauma and/or intraoperative bleeding. As a first step in demonstrating the potential utility of this approach, our objective was to ascertain the ability of the PEG-LysNH2 to adhere to and seal injured tissues, as well as to maintain the seal under physiological conditions. METHODS: The efficacy of the PEG-LysNH2 in sealing injured tissues was evaluated using an ex-vivo pressure testing system. A 2.5 mm incision was made on intact ex-vivo tissues and then sealed with the PEG-LysNH2. Application of the PEG-LysNH2 was followed by 1) step-wise pressure increase to a maximum of 250 mmHg and 2) fluctuating pressures, between 100-180 mmHg with a rate of 3 Hz, over a 24-hour period. The performance of the PEG-LysNH2 was compared to those of commercially available sealants and adhesives. RESULTS: During gradual pressure increase, mean pressures at 30 seconds (P30) ranged between 206.36 - 220.17 mmHg for the sealants, and they were greater than control and suture groups (p < 0.01 and p = 0.013, respectively). Additionally, all products held under fluctuating pressures: mean pressures ranged between 135.20 - 160.09 mmHg, and there were no differences observed between groups (p = 0.96). CONCLUSIONS: The efficacy of the PEG-LysNH2 was significantly superior to conventional injury repair methods (sutures) and did not differ from those of commercially available products when sealing small incisions.