RESUMEN
We applied a market-leading, single-use negative pressure wound therapy device to a robotic venous leg ulcer system and compared its fluid handling performance with that of standard of care, superabsorbent and foam dressings and compression therapy. For each tested product, we determined a metrics of retained, residual, evaporated and (potential) leaked fluid shares, for three exudate flow regimes representing different possible clinically relevant scenarios. The single-use negative pressure wound therapy system under investigation emerged as the leading treatment option in the aspects of adequate fluid handling and consistent delivery of therapeutic-level wound-bed pressures. The superabsorbent dressing performed reasonably in fluid handling (resulting in some pooling but no leakage), however, it quickly caused excessive wound-bed pressures due to swelling, after less than a day of simulated use. The foam dressing exhibited the poorest fluid handling performance, that is, pooling in the wound-bed as well as occasional leakage, indicating potential inflammation and peri-wound skin maceration risks under real-world clinical use conditions. These laboratory findings highlight the importance of advanced robotic technology as contemporary means to simulate patient and wound behaviours and inform selection of wound care technologies and products, in ways that are impossible to achieve if relying solely on clinical trials and experience.
RESUMEN
BACKGROUND: Lower limb ulcers not responding to standard treatments after 8 weeks are defined as chronic wounds, and they are a significant medical problem. Blue light (410-430 nm) proved to be effective in treating wounds, but there is a lack of data on chronic wounds in clinical practice. The aim of the study was to determine if blue light photobiomodulation with EmoLED (Emoled Srl, Sesto Fiorentino, Florence, Italy) medical device in addition to standard of care is more effective compared to standard of care alone in promoting re-epithelialization of chronic wounds of lower limbs in 10 weeks. METHODS: Ninety patients affected by multiple or large area ulcers were enrolled. To minimize all variabilities, each patient has been used as control of himself. Primary endpoint was the comparison of the re-epithelialization rate expressed as a percentage of the difference between the initial and final area. Secondary endpoints were: treatment safety, pain reduction, wound area reduction trend over time, healing rate. RESULTS: At week 10, the wounds treated with EmoLED in addition to standard care showed a smaller residual wound area compared to the wounds treated with standard of care alone: 42.1% vs. 63.4% (P=0.029). The difference is particularly evident in venous leg ulcers, 33.3% vs. 60.1% (P=0.007). 17 treated wounds and 12 controls showed complete healing at week 10. Patients showed a significant reduction in pain (P=2×10-7). CONCLUSIONS: Blue light treatment in addition to standard of care accelerates consistently the re-epithelialization rate of chronic wounds, especially venous leg ulcers and increases the chances of total wound healing in 10 weeks.
Asunto(s)
Terapia por Luz de Baja Intensidad , Úlcera Varicosa , Humanos , Dolor , Úlcera , Úlcera Varicosa/radioterapia , Cicatrización de HeridasRESUMEN
BACKGROUND: Concentrated Growth Factors (CGF) is a concentration of second generation autologous growth factors compared to platelet rich plasma (PRP) and represents a multifactorial stimulation system that can be used for the management and treatment of chronic skin ulcers. AIM: The aim of this work is to evaluate the additional benefits of the CGF compared to the standard of dressing and its effects on the dynamics of the healing process. METHODS: Autologous CGFs were obtained from 100 patients with chronic mixed ulcers (venous ulcers in patients with II stage claudication) of the lower limbs in a multicentric controlled randomized study. RESULTS: The results showed a significant advantage in the use of CGF in association with cleansing and selective compression in the healing time and stabilization of mixed ulcers of the lower extremities. CONCLUSIONS: These results support the CGF's clinical use for improving clinical outcomes in mixed ulcers of the legs.
RESUMEN
OBJECTIVE: This study was designed to clinically evaluate the efficacy of a bacteria- and-fungi-binding mesh (BFBM) dressing to modify the bacterial load of pressure ulcers (PUs) of categories 3 and 4, when used as a wound contact layer (WCL) during negative pressure wound therapy (NPWT). METHODS: This was an observational single-centre study in patients with PUs of categories 3 or 4, who were treated with NPWT. Patients were observed for 7 days and received NPWT at -80 mm Hg with the BFBM dressing as the WCL. Wound biopsies were performed at inclusion (B0), at 48 hours (B1), and at day 7 (B7). Bacteria- and fungi-binding mesh dressings were examined for bacterial load at 48 hours (D1) and at 7 days (D7). The primary endpoint was the changes in bacterial loads. RESULTS: Fifty patients were enrolled; 43 (86%) of their PUs were on the sacrum. At B0, 3 groups of wounds were identified by the bioburden level: group A had negative results (28%) to bacterial loads from 102 to 5 x 103 colony forming units (CFU) CFU/mL (18%); group B had 104 to 105 CFU/mL (18%); and group C with ≥ 106 CFU/mL (36%). The authors did not find any significant difference in bacterial loads in group A, but significant differences were found in group B at B1 and B7 (P = 0.04 and P = 0.0067) and in group C at B1 and B7 (P < 0.00001). There was no significant difference on the bacterial loads of the dressing at D1 and D7 (P = 0.823). No device-related adverse events were reported. CONCLUSION: The BFBM dressing seems to be at the origin of a statistically significant reduction of bacterial burden in wounds with moderate or high levels of colonization. The authors' findings suggest BFBM dressings may be a WCL of choice during the treatment of chronic wounds with NPWT.