Search

To assess the safety and efficacy of antimicrobial peptide PL-5 (Peceleganan) spray in the treatment of wound infections.Antimicrobial peptide PL-5 spray is a novel topical antimicrobial agent.We conducted a multicenter, open-label, randomized, controlled phase IIb clinical trial to evaluate the efficacy and safety of PL-5 spray, as compared with silver sulfadiazine, in patients with skin wound infections. The primary efficacy outcome was the clinical efficacy rate on the first day after ending the treatment (D8). The secondary efficacy outcome was the clinical efficacy rate on the fifth day posttreatment (D5), the bacteria clearance rate, and the overall efficacy rate at the mentioned 2 time points. The safety outcomes included adverse reactions and pharmacokinetic analysis posttreatment.A total of 220 patients from 27 hospitals in China were randomly assigned to 4 groups. On D8, the efficacy rate was 100.0%, 96.7%, 96.7% for the 1‰ PL-5, 2‰ PL-5, 4‰ PL-5 groups, respectively, as compared with 87.5% for the control group. The efficacy rate among the 4 groups was significantly different (P0.05). On D5, the efficacy rate was 100.0%, 93.4%, 98.3% for the 1‰ PL-5, 2‰ PL-5, 4‰ PL-5 groups, respectively, as compared with 82.5% for the control group. The efficacy rate among the 4 groups was significantly different (P0.05). The blood concentration of PL-5 was not detectable in pharmacokinetic analysis. No severe adverse event related to the application of PL-5 was reported.Antimicrobial peptide PL-5 spray is safe and effective for the treatment of skin wound infections.ChiCTR2000033334.

Background Autologous fat grafts have been widely in use for reconstruction, contour abnormalities, and cosmetic surgeries. However, the grafted fat one-year survival rate is unpredictable and always low (20%–80%). Standardizing the existing transplantation technology is difficult due to the limiting conditions. Scaffold materials or drugs are unsuitable to employ because of legal restrictions, complex production, and undetermined hazards. Therefore, a simpler and more effective approach to improve grafted fat survival rate is using commercial products as additives. Earlier studies proved that porcine acellular dermal matrix (PADM), a biomaterial clinically used for wound repair, could work as a scaffold for lipo-implantation. This study aimed at investigating the hitherto unclear effect of PADM on transplanted fat survival. Methods Thirty-two 8-week-old female nude mice were divided into two groups. Control mice received a 300 μl fat injection, while the PADM group mice were injected with a 300 μl PADM-fat mixture. After a 4-week treatment, fat weight and liquefaction ratio were assessed. Histological changes were quantified via hematoxylin & eosin (H&E) staining. Macrophage infiltration and vascular regeneration were revealed using an anti-CD34 antibody. Mouse and human mRNA expression levels were gauged via RNA-sequencing. On the third day post implantation, the mRNA expression levels of inflammatory genes Mcp-1 and Tnf-α were measured by qRT-PCR. Results The weight of surviving grafted fat did not differ between the control and the PADM group. However, adding PADM significantly decreased fat liquefaction. H&E-stained sections showed that PADM decreased fat necrosis, increased fat tissue regeneration, and raised CD34 levels in the regenerated tissue. RNA-sequencing showed that, compared to controls, fats from PADM-added group expressed more mouse-related mRNA but less human-related mRNA. The following GO and KEGG analysis showed that added PADM increased extracellular matrix (ECM) genes expression levels. The qRT-PCR showed that adding PADM increased Mcp-1 and Tnf-α mRNA expression levels. Conclusions In summary, PADM addition increased fat survival rate by reducing fat liquefaction through an increased macrophage infiltration, ECM regeneration, and revascularization. Therefore, PADM addition is a workable application in autologous fat grafting. No Level Assigned This journal requires that authors assign a level of evidence to each article. For a full description of these Evidence-Based Medicine ratings, please refer to the Table of Contents or the online Instructions to Authors www.springer.com/00266.

Background: Antimicrobial Peptide PL-5 (Peceleganan) Spray is a novel topical antimicrobial agent targeted on the treatment of skin wound infections. Methods: We conducted a multicenter, open-label, randomized, controlled phase IIb clinical trial to evaluate the efficacy and safety of PL-5 Spray, as compared with silver sulfadiazine, in patients with skin wound infections. The primary efficacy outcome was the clinical efficacy rate on the first day after ending the treatment (D8). The secondary efficacy outcome was the clinical efficacy rate on the fifth day post-treatment (D5), the bacteria clearance rate and the overall efficacy rate at the mentioned two timepoints. The safety outcomes included adverse reactions and pharmacokinetic analysis post-treatment. Findings: Between Jul 29, 2020, and May 10, 2021, a total of 220 patients from 27 hospitals in China were randomly assigned to 4 groups. On D8, the efficacy rate was 91·6%, 83·6%, 85·0% for the 1 ‰ PL-5, 2 ‰ PL-5, 4 ‰ PL-5 groups respectively, as compared with 60% for the control group. The efficacy rate between each PL-5 group and the control group was significantly different (P

Inspired from the sophisticated bilayer structures of natural dermis, here, we reported collagen/chitosan based two-compartment and bi-functional dermal scaffolds. Two functions refer to mediating rapid angiogenesis based on recombinant human vascular endothelial growth factor (rhVEGF) and antibacterial from gentamicin, which were encapsulated in PLGA microspheres. The gentamicin and rhVEGF encapsulated PLGA microspheres were further combined with collagen/chitosan mixtures in low (lower layer) and high (upper layer) concentrations, and molded to generate the two-compartment and bi-functional scaffolds. Based on morphology and pore structure analyses, it was found that the scaffold has a distinct double layered porous and connective structure with PLGA microspheres encapsulated. Statistical analysis indicated that the pores in the upper layer and in the lower layer have great variations in diameter, indicative of a two-compartment structure. The release profiles of gentamicin and rhVEGF exceeded 28 and 49 days, respectively. In vitro culture of mouse fibroblasts showed that the scaffold can facilitate cell adhesion and proliferation. Moreover, the scaffold can obviously inhibit proliferation of Staphylococcus aureus and Serratia marcescens, exhibiting its unique antibacterial effect. The two-compartment and bi-functional dermal scaffolds can be a promising candidate for skin regeneration.

To observe the effects of respiratory support with high frequency jet ventilation (HFJV) in severely burned patients with inhalation injury during early postburn stage.Twenty severely burned patients with TBSA of 79.6 +/- 29.3% and inhalation injury were enrolled in the study. Nineteen cases received tracheostomy after admission and only one received nasal intubation. All the patients underwent HFJV to correct hypoxia. The changes in blood gas analysis, respiratory rate and pulse were recorded before and 11 days after the ventilation.Tracheostomy was performed on 2.7 +/- 2.4 postburn days (PBDs), and HFJV was given during 4.4 +/- 2.9 PBDs. PaO(2) was evidently higher during 1 - 3 days after HFJV than that before the ventilation (P0.01) and remained at high level for 1 week after HFJV. There was no change in PaCO(2), respiratory rate and pulse during the ventilation.HFJV was beneficial in improving oxygenation and without any obvious side effects during the early management of severely burned patients with inhalation injury. This might be an optimal respiratory support pattern.

As an initial factor, sepsis and multiple organ dysfunction syndrome (MODS) caused by sepsis are the principal causes of death in burned patients. In this report, we measured the levels of tumor necrosis factor (TNF)-α, interleukin (IL)-6 and IL-8 in severely burned patients with sepsis after the initiation of continuous vein-vein hemodiafiltration (CVVHDF) to evaluate the clinical usefulness of CVVHDF on the removal of key mediators. The vital sign indices, such as the heart rate (HR), respiration (R) and central venous pressure (CVP), were recorded at 0 and 42 h in each group. Further, the laboratory examinations indexes, such as the white blood cell count, blood sugar, serum sodium, blood urea nitrogen and serum creatinine, were detected in venous blood samples. Twenty-two severely burned patients suffering from sepsis were randomized into the control group (A, n = 11) and the experimental group (B, n = 11). The patients in group A underwent conventional treatment, and those in group B received conventional+CVVHDF treatment. The vital signs, such as the HR, R, and CVP, and laboratory examination indices, such as the blood cell count, blood sugar, serum sodium, blood urea nitrogen, and serum creatinine, dropped significantly in group B compared with those in group A at 42 h (P < 0.05). The plasma levels of TNF-α, IL-6 and IL-8 were measured at 0, 12, 18, 24, 36 and 42 h after the start of CVVHDF and at the same time points after the patients were diagnosed with sepsis in group A. The plasma levels of TNF-α in group B decreased by 32% at 18 h after the start of CVVHDF and decreased by 43% at 42 h after the start of CVVHDF; however, these levels were increased compared with the normal values (P < 0.01). The plasma levels of IL-6 decreased at 18 h after the start of CVVHDF (0.274 ± 0.137 ng/ml). Following a brief increase at 24 h, the plasma levels of IL-6 again decreased continuously until the end of the investigation (0.192 ± 0.119 ng/ml). The plasma levels of IL-8 in group B decreased by 56% at 18 h after the start of CVVHDF, but they were increased compared with the normal values (P < 0.01). The plasma levels of IL-8 in group B decreased by 70% at 42 h after the start of CVVHDF, but they were increased compared with the normal values (P < 0.01). The MODS incident was 4 of 11 in group A compared with 1 of 11 in group B (P < 0.01). In conclusion, CVVHDF can effectively reduce the levels of TNF-α, IL-6 and IL-8 as well as the MODS incidence in patients with serious burns.