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3,146 result(s) for "negative pressures"
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A Prospective, Controlled, Randomised, Clinical Study of Negative Pressure Device Without Foam or Gauze for Skin and Soft Tissue Defects
All common negative pressure wound therapy (NPWT) systems include a filler material usually foam or gauze at the wound/device interface. The filler material distributes the negative pressure evenly to all parts of the wound. The foam or gauze may fragment contributing to foreign material being retained in the wound, becoming colonised with bacteria over time, and painful dressing changes. To mitigate these, negative aspects, an impermeable embossed single‐layer NPWT membrane dressing has been developed. The dressing has been coined Negative Pressure—Platform Wound Device (NP‐PWD) and a foam or gauze is not required to deliver negative pressure. Rather, the pressure is permeated via the spaces between the embossed pyramids and the wrinkles in the membrane. The purpose of this study was to compare the NP‐PWD to the standard of care (SOC) NPWT system in the treatment of skin and soft tissue defects. This was a prospective, randomised, controlled clinical trial. The wounds were treated with the NP‐PWD or SOC NPWT system. The randomised treatment was applied for 2 days to up to 9 days after the initial application. Follow‐up data were collected at each dressing change/removal and included photographs, and assessments for wound healing, infection, and adverse events. In total 24 subjects (12 NP‐PWD and 12 SOC) completed the study. The NP‐PWD was easy to use and fast to apply and the patients tolerated it well. The transparency of the NP‐PWD allowed the provider to see the wound without removing the dressing which is an improvement over traditional NPWT. In terms of wound healing, inflammation, pain, and infection, no differences were observed between the NP‐PWD and the SOC NPWT system. The NP‐PWD is a simplified, single component NPWT system eliminating the use of the filler material that commonly causes challenges during treatment.
Novel cell culture system for monitoring cells during continuous and variable negative‐pressure wound therapy
Background Although the clinical efficacy of negative‐pressure wound therapy (NPWT) is well known, many of its molecular biological mechanisms remain unresolved, mainly due to the difficulty and paucity of relevant in vitro studies. We attempted to develop an in vitro cell culture system capable of real‐time monitoring of cells during NPWT treatment. Materials and methods A novel negative‐pressure cell culture system was developed by combining an inverted microscope, a stage‐top incubator, a sealed metal chamber for cell culture, and an NPWT treatment device. Human keratinocytes, PSVK‐1, were divided into ambient pressure (AP), continuous negative‐pressure (NPc), and intermittent negative‐pressure (NPi) groups and cultured for 24 h with scratch assay using our real‐time monitoring system and device. Pressure inside the device, medium evaporation rate, and the residual wound area were compared across the groups. Results Pressure in the device was maintained at almost the same value as set in all groups. Medium evaporation rate was significantly higher in the NPi group than in the other two groups; however, it had negligible effect on cell culture. Residual wound area after 9 h evaluated by the scratch assay was significantly smaller in the NPc and NPi groups than in the AP group. Conclusion We developed a negative‐pressure cell culture device that enables negative‐pressure cell culture under conditions similar to those used in clinical practice and is able to monitor cells under NPWT. Further experiments using this device would provide high‐quality molecular biological evidence for NPWT.
Particulate Evacuation Under NPWT: Bench Evaluation of a Multilayer Foam Prototype Versus Commercial Dressings in a Simulated Exudate Model
Negative pressure wound therapy (NPWT) is widely used to facilitate healing by improving local perfusion, reducing edema and controlling exudate. The porous foam dressing is central to NPWT effectiveness, however, its performance in viscous, particle‐rich exudates remains challenging. Standard industry tests often rely on protein‐free aqueous solutions, which overlook the complex rheology and particulate load of real wounds. This study reports a bench evaluation of a multilayer foam prototype compared with three commercial dressings under NPWT, using a simulated viscous exudate with suspended particles. We recorded 60‐min drainage curves and quantified effluent turbidity as a simple, interpretable proxy for particulate transport, summarised as percentage of input turbidity recovered. The mass‐based endpoint (percent solid matter recovered) showed the same ranking as turbidity. At −75 mmHg, the prototype recovered 31.6% of input turbidity, exceeding commercial foams (≤ 9.7%). At −125 mmHg, particulate recovery decreased across all dressings (≤ 9.1%). A matrix‐only control indicated that commercial effluents, particularly at −75 mmHg, clustered near background level, whereas the prototype evacuated substantially more particulate while maintaining robust fluid drainage. These findings suggest that moderate negative pressure and multilayer architecture can help preserve channel patency and reduce clogging in complex exudates. We highlight the need for test methodologies that incorporate viscosity and particulate content, and for practical guidance that links dressing architecture and pressure settings to exudate characteristics. Prospective validation, including larger‐sample confirmation, particle‐size distributions and ultimately clinical endpoints, is warranted. Summary Clinical selection of NPWT pressure and dressing should reflect exudate properties, and industrial standards should measure viscosity and particulate load instead of using protein‐free aqueous surrogates to ensure accurate, clinically relevant testing. This study evaluates a multilayer foam prototype against three commercial dressings under NPWT, using an innovative simulated viscous exudate with suspended particles to characterise drainage behaviour via time‐volume curves and a simple, interpretable endpoint (percent of input turbidity recovered; confirmed by percent solid matter recovered). Findings show that particulate evacuation depends on pressure and dressing architecture: at −75 mmHg the prototype evacuates substantially more particulate (31.6%) than commercial foams (≤ 9.7%), whereas at −125 mmHg particulate recovery decreases across all dressings (≤ 9.1%), consistent with compression‐induced pore narrowing and filter‐cake formation that limit particle transport.
Incisional negative pressure wound therapy for the prevention of surgical site complications in Paediatric patients with non‐idiopathic scoliosis: A randomized clinical trial
Surgical wound complications are adverse events with important repercussions for the health of patients and health system. Surgical site infections and wound dehiscences are among the most important surgical wound complications, with a high incidence in paediatric patients undergoing surgery for non‐idiopathic scoliosis. Incisional negative pressure wound therapy for surgical incisions is used as a preventive measure against surgical wound complications in adults; however, there has been scant evidence for using it in children. The purpose of this study is to evaluate the cost‐effectiveness of incisional negative pressure wound therapy in preventing surgical wound complications in paediatric patients undergoing surgery to treat non‐idiopathic scoliosis. Randomized clinical trial. Children younger than 18 years of age undergoing surgery for non‐idiopathic scoliosis were randomly assigned into two groups to receive one of two different types of dressings for the first 7 days after surgery. One group were treated with a postoperative hydrofibre and hydrocolloid dressing with silver for wounds (control group), and the other group received a single‐use incisional negative pressure wound therapy system (intervention group). The wounds were assessed after removal of the dressings at 7 days after surgery and again at 30, 90, and 180 days after surgery. Surgical wound complications, sociodemographic variables, variables related to the procedure and postoperative period, economic costs of treatment of surgical wound complications, and time to healing of the surgical wound were recorded. Per protocol and per intention to treat analysis was made. The per protocol incidence of surgical wound complications was 7.7% in the intervention group versus 38.5% in the control group (p = 0.009; Fisher exact test. RR = 0.20 IC95%: 0.05–0.83). Surgical wound dehiscence, surgical site infections, seroma, and fibrin were the most common surgical wound complications. The type of surgery, duration of surgery, and patients' age were associated with a higher risk for surgical wound complications. Postoperative hydrofibre and hydrocolloid dressing with silver for wounds were found to be associated with a longer time to healing. Initial costs for dressings in the group receiving incisional negative pressure wound therapy were higher, but the total postoperative costs were higher for those receiving postoperative hydrofibre and hydrocolloid dressing with silver for wounds. It was found that for each US $1.00 of extra costs for using incisional negative pressure wound therapy, there was a benefit of US$ 12.93 in relation to the cost of complications prevented. Incisional negative pressure wound therapy is cost‐effective in the prevention of surgical wound complications in children undergoing surgery for non‐idiopathic scoliosis.
Cost-effectiveness analysis of single use negative pressure wound therapy dressings (sNPWT) compared to standard of care in reducing surgical site complications (SSC) in patients undergoing coronary artery bypass grafting surgery
Background There is a growing interest in using negative pressure wound therapy in closed surgical incision to prevent wound complications which continue to persist following surgery despite advances in infection measures. Objectives To estimate the cost-effectiveness of single use negative pressure wound therapy (sNPWT) compared to standard of care in patients following coronary artery bypass grafting surgery (CABG) procedure to reduce surgical site complications (SSC) defined as dehiscence and sternotomy infections. Method A decision analytic model was developed from the Germany Statutory Health Insurance payer’s perspective over a 12-week time horizon. Baseline data on SSC, revision operations, length of stay, and readmissions were obtained from a prospective observational study of 2621 CABG patients in Germany. Effectiveness data for sNPWT was taken from a randomised open label trial conducted in Poland which randomised 80 patients to treatment with either sNPWT or standard care. Cost data (in Euros) were taken from the relevant diagnostic related groups and published literature. Results The clinical study reported an increase in wounds that healed without complications 37/40 (92.5%) in the sNPWT compared to 30/40 (75%) patients in the SC group p  = 0.03. The model estimated sNPWT resulted in 0.989 complications avoided compared to 0.952 and the estimated quality adjusted life years were 0.8904 and 0.8593 per patient compared to standard care. The estimated mean cost per patient was €19,986 for sNPWT compared to €20,572 for SC resulting in cost-saving of €586. The findings were robust to a range of sensitivity analyses. Conclusion The sNPWT can be considered a cost saving intervention that reduces surgical site complications following CABG surgery compared to standard care. We however recommend that additional economic studies should be conducted as new evidence on the use of sNPWT in CABG patients becomes available to validate the results of this economic analysis.
Negative pressure wound therapy versus usual care in patients with surgical wound healing by secondary intention in the UK (SWHSI-2): an open-label, multicentre, parallel-group, randomised controlled trial
Surgical wound healing by secondary intention (SWHSI) presents a substantial management and financial challenge. Negative pressure wound therapy (NPWT) has increasingly been used as a treatment despite an absence of comparative evidence of effectiveness. We evaluated the effectiveness of NPWT compared with usual care for improving time to wound healing in patients with an SWHSI. We did a pragmatic, open-label, multicentre, parallel-group, randomised controlled trial in 29 UK National Health Service Trusts. Participants aged 16 years or older with an SWHSI appropriate for both study treatments (NPWT or usual care) were randomly assigned (1:1) by a centralised web-based system. Randomisation was stratified by wound location, wound area, and study centre. Participants were followed up for 12 months. Participants and clinical and research teams could not be masked to treatment. Assessors masked to treatment reviewed wound photography to verify the outcome. The primary outcome was time to wound healing (days from randomisation to complete epithelial cover), analysed via intention to treat using Kaplan–Meier survival curves and a proportional hazards Cox regression model. The trial was registered with ISRCTN, ISRCTN26277546. Between May 15, 2019, and Jan 13, 2023, 686 participants with an SWHSI were randomly assigned to receive NPWT (n=349) or usual care (n=337). All participants were included in the primary analysis. Most participants were diabetic (n=549, 80·0%) and had a single SWHSI (n=622, 90·7%), located on the foot or leg (n=620, 90·4%), arising after vascular surgery (n=619, 90·2%). There was no clear evidence that NPWT reduced the time to wound healing compared with usual care (hazard ratio 1·08 [95% CI 0·88–1·32], p=0·47). There were 448 adverse events, of which 14 were serious (nine participants in the NPWT group and five participants in the usual care group); 124 were deemed potentially related to treatment. NPWT was found not to be cost-effective compared with usual care. In patients with a lower limb SWHSI, including those with complications of diabetes, there is no clear evidence that NPWT reduced the time to wound healing compared with standard dressings. These findings do not support the use of NPWT to augment SWHSI healing. National Institute for Health Research Health Technology Assessment Programme.
Comparison of Single Use and Traditional Negative Pressure Wound Therapy Devices in Lower Extremity Ulcers: A US Real‐World Evidence Analysis of NetHealth Data
Annually, 49 million people worldwide are impacted by lower extremity ulcers (LEUs). Diabetic foot ulcers (DFUs) and venous leg ulcers (VLUs) are the most common LEUs. Negative pressure wound therapy (NPWT) has emerged as an effective intervention for complex wounds, offering numerous favourable wound healing outcomes. The objective of this study was to evaluate the effectiveness of single‐use NPWT (sNPWT) versus traditional NPWT (tNPWT) for wound closure in LEUs. Real‐world data was obtained from the US‐based Net Health outpatient database between January 2014 and October 2020 and included patients with LEUs (DFU or VLU) who had been treated with sNPWT or tNPWT. The rate of wound closure and time to wound closure were selected as endpoints. The wound closure rate was significantly higher for all LEUs (p = 0.039), VLUs alone (p = 0.003) and there was no difference for DFU (p = 0.90) that were treated with sNPWT versus tNPWT. The median time to wound closure was significantly shorter for sNPWT (114 days) compared to tNPWT (140 days, p < 0.01). Using sNPWT was associated with significantly higher wound closure rates and shorter time to wound closure. The results provide supportive evidence for using sNPWT for LEUs, demonstrating the opportunity to directly decrease the clinical burden of LEUs on patients. Subgroup analysis revealed a significant difference in wound closure rates for VLU, while no significant difference was observed for DFU. The overall LEU findings may be attributed to differences in the mechanisms of action between the two devices.
Negative pressure wound therapy promotes wound healing by down-regulating miR-155 expression in granulation tissue of diabetic foot ulcers
Our study aims to investigate the effect of negative pressure wound therapy (NPWT) on microRNA-155 (miR-155) in the granulation tissue of patients suffering from diabetic foot ulcers (DFUs) and its correlation with wound healing. A total of sixty patients diagnosed with DFUs were randomly assigned to either the NPWT group ( n  = 40) or the Non-NPWT group ( n  = 20) in a 2:1 ratio. After debridement, the NPWT group received NPWT treatment for one week, while the Non-NPWT group underwent routine dressing therapy. The expression of miR-155 in DFU granulation tissues was evaluated by qRT-PCR before and after treatment for one week. Following termination, wound healing rates were assessed in the NPWT group, and the correlation between variations in miR-155 expression (ΔmiR-155) and wound healing was analyzed pre and post NPWT treatment. In vitro experiments were conducted to investigate the effects of negative pressure on variations of miR-155 expression, as well as proliferation, migration, and apoptosis in normal human dermal fibroblasts (NHDFs). The NPWT group showed a decrease in miR-155 expression in wound granulation tissue compared with pre-treatment [4.12 (1.22, 14.85) vs. 6.83 (2.15, 15.72), P  < 0.05]. Conversely, there was no statistically significant difference in miR-155 expression in wound granulation tissue between pre-treatment and post-treatment in the Non-NPWT group ( P  > 0.05). However, analysis revealed a positive correlation between ΔmiR-155 and wound healing rate after 4 weeks in the NPWT group (χ 2  = 4.829, P  = 0.028). The in vitro experiments showed a significant decrease in miR-155 expression in NHDFs under negative pressure measured at -125 mmHg ( P  < 0.05). This reduction in miR-155 expression, in turn, enhanced the proliferation and migration ability while decreasing the apoptosis rate of NHDFs by targeting the upregulation of fibroblast growth factor 7 (FGF7) gene expression ( P  < 0.05). It is concluded that NPWT promotes DFU healing by reducing the expression of miR-155 in granulation tissue and the efficacy of NPWT correlated with altered miR-155 expression in wound tissue.
Integrative cardiovascular dose–response to graded lower‐body negative pressure
Lower‐body negative pressure (LBNP) has been posited as a potential spaceflight countermeasure to counteract the physiological deconditioning related to fluid shifts in microgravity. However, open questions remain regarding the magnitude of LBNP that should be applied. We systematically characterized the cardiovascular effects of LBNP and quantified the effect size of varied LBNP doses across different parts of the cardiovascular system. Twenty‐four subjects (12 male and 12 female) were exposed to graded LBNP, increasing from 0 to −50 mmHg in 10 mmHg increments, in both supine (0°) and 15° head‐down tilt postures. At each pressure level, subjects first underwent a 6 min stabilization period to reach a steady‐state cardiovascular response. We then assessed a wide range of variables, including those related to the systemic circulation, cardiovascular control, and haemodynamics of the eyes and neck. Building on the experimental data, dose–response curves were constructed using a Bayesian multivariate hierarchical modelling framework to quantify the effect size of every variable considered when subjected to LBNP. The methodology allows direct comparison of the variables and the underlying structural relationships between them. Furthermore, we demonstrated the potential for LBNP to reduce jugular venous flow stagnation, which is considered one of the major health risks during human spaceflight. The dose–response curves and effect sizes generated from this research effort establish the most comprehensive framework available to date that characterizes physiological responses to LBNP. These results directly inform the development of countermeasures to mitigate the negative effects of spaceflight, including cardiovascular deconditioning, spaceflight‐associated neuro‐ocular syndrome and venous thromboembolism events. What is the central question of this study? This study evaluates lower‐body negative pressure (LBNP) as a countermeasure for spaceflight risks, including cardiovascular deconditioning, spaceflight‐associated neuro‐ocular syndrome, and venous thromboembolism events. The central question focuses on determining the LBNP dose required to mitigate these risks. What is the main finding and its importance? Using supine and 15° head‐down tilt positions, we generated LBNP dose–response curves to assess haemodynamics, autonomic, ocular, and neck responses across various LBNP levels. A Bayesian multivariate framework revealed significant inter‐variable relationships and effect size differences. Key findings highlight the potential of LBNP to reduce jugular venous flow stagnation during microgravity. This comprehensive analysis informs countermeasure development to address spaceflight‐induced physiological challenges.
Prophylactic Negative Pressure Wound Therapy Reduces Superficial Surgical Site Infection Risk of Emergency Surgery Patients: Results of a Multicenter Randomised Prospective Clinical Trial
Despite modern aseptic precautions, surgical site infection remains a significant problem. Although the benefits of negative pressure wound therapy in the treatment of chronic wounds are well established, high‐level evidence is still lacking on the potential role of negative pressure in the prevention of surgical site infections. We conducted a multicenter, randomised, prospective trial of closed incision vacuum therapy. A total of 90 general surgery patients undergoing emergency laparotomy were enrolled and randomised, 45 cases in the treatment group and 45 cases in the control group. Our aim was to show a significant difference in the rate of surgical site infection between the two groups. In the study group, laparotomy wounds were treated with a single 5‐day course of prophylactic vacuum therapy, whereas the control group underwent conventional postoperative wound management with sterile gauze dressings. Ten of the 45 patients in the study group developed a surgical site infection compared to 20 of 45 in the control group (22.2% vs. 44.4% p = 0.025). Upon further analysis, the proportion of superficial SSIs was found to be significantly lower in the ciNPWT group (40% vs. 20% p = 0.038), whereas the difference in deep SSI rates was not statistically significant (4.4% vs. 4.4% p = 1.0). In conclusion, negative pressure wound therapy is not only an effective way to heal chronic wounds, but it's prophylactic use may reduce the overall rate of surgical site infections. Trial Registration: Clinicaltrials.gov: NCT03716687