First safety and performance evaluation of T45K, a self-assembling peptide barrier hemostatic device, after skin lesion excision
Dermatologic Surgery : Official Publication for American Society for Dermatologic Surgery [Et Al.]. 2018;44((7):):939-948
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.This is an open-access article distributed under the terms of the Creative Commons Attribution-Non Commercial-No Derivatives License 4.0 (CCBY-NC-ND), where it is permissible to download and share the work provided it is properly cited. The work cannot be changed in any way or used commercially without permission from the journal.
Photographic evaluation of different adrenaline-containing tumescent solutions on skin graft donor site bleeding: A prospective randomised trial
Burns : journal of the International Society for Burn Injuries. 2018;44((8):):2018-2025.
BACKGROUND Tumescent infiltration is a technique to reduce skin graft donor site bleeding, however there are no studies comparing tumescent solutions with different concentrations of adrenaline on donor site blood loss. We sought to evaluate the effect on skin donor site bleeding of different adrenaline concentrations in adrenaline-containing tumescent solutions in a prospective randomised trial. METHODS Donor sites were marked into thirds and each segment randomised to receive tumescent infiltration containing no adrenaline, adrenaline 1:500,000, or adrenaline 1:250,000. Donor sites were photographed 10s after skin graft harvest. A laparotomy sponge was then placed onto the wound for a further 20s and photographed. These photographs were divided into their corresponding thirds and each scored on a scale of 0 (no bleeding) to 5 (severe bleeding) by a blinded independent panel of plastic surgeons. RESULTS 11 patients (15 donor sites) were recruited. Donor site segments infiltrated with adrenaline 1:250,000 had significantly lower wound bleeding and sponge staining mean rank scores compared with segments infiltrated with adrenaline 1:500,000 (9.47 vs 21.57; p=0.035 and 9.63 vs 21.37; p<0.043 respectively). Segments infiltrated with adrenaline 1:500,000 had significantly lower wound bleeding and sponge staining mean rank scores compared with segments that were not infiltrated with adrenaline (21.5 7 vs 37.97; p=0.002 and 21.37 vs 38; p<0.002 respectively). There were no local or systemic complications. CONCLUSIONS We demonstrate that donor site infiltration with different adrenaline-containing tumescence solutions cause significantly different photographic bleeding scores. Adrenaline 1:250,000 tumescence resulted in significantly lower bleeding scores than lower concentrations of adrenaline without compromising safety or wound healing. These findings suggest that adrenaline tumescence reduces donor site blood loss in a dose-dependent manner.