Showing papers in "Advances in wound care in 2018"
TL;DR: The pathophysiology of both acute and chronic wounds and possible strategies to control the immune system to accelerate chronic wound closure and promote skin regeneration (scar-less healing) of acute wounds are discussed.
Abstract: Significance: The immune system plays a central role in orchestrating the tissue healing process. Hence, controlling the immune system to promote tissue repair and regeneration is an attractive approach when designing regenerative strategies. This review discusses the pathophysiology of both acute and chronic wounds and possible strategies to control the immune system to accelerate chronic wound closure and promote skin regeneration (scar-less healing) of acute wounds. Recent Advances: Recent studies have revealed the key roles of various immune cells and immune mediators in skin repair. Thus, immune components have been targeted to promote chronic wound repair or skin regeneration and several growth factors, cytokines, and biomaterials have shown promising results in animal models. However, these novel strategies are often struggling to meet efficacy standards in clinical trials, partly due to inadequate drug delivery systems and safety concerns. Critical Issues: Excess inflammation is a major culprit in...
300 citations
TL;DR: The results show the potential of using topically applied ADSC-derived exosomes containing MALAT1 for treating ischemic wounds and harnessing the power of stem cell paracrine signaling capabilities without applying the cells.
Abstract: Objective: Chronically ill patients heal recalcitrant ulcerative wounds more slowly. Human adipose-derived stem cells (hADSCs) play an important role in tissue regeneration and exosomes secreted by hADSC contribute to their paracrine signaling. In addition to cytokines, lipids and growth factors, hADSC secrete mRNA, miRNA, and long noncoding (lnc) RNA into exosomes. In this study we examined the role of lncRNA MALAT1 (metastasis-associated lung adenocarcinoma transcript 1), an abundant lncRNA in exosomes from conditioned media (CM), on cell migration and ischemic wound healing. Approach: CM and isolated exosomes from hADSC were applied to human dermal fibroblast (HDF) in scratch assays and electric cell-substrate impedance sensing (ECIS) assays. CM was also applied to a rat model of ischemic wound healing and wound closure was followed. Results: CM stimulated cell migration of HDFs in vitro by 48%. CM stimulated the closure of ischemic wounds in a rat model 50% faster than unconditioned media. The depletion of MALAT1 in adipose-derived stem cell (ADSC) CM significantly reduced cell migration. Since MALAT1 is secreted into exosomes, a purified population of exosomes was applied to HDF where they enhanced cell migration in a similar manner to FGF-2 or basic fibroblast growth factor (bFGF) in ECIS wound healing assays. The uptake of exosomes by HDF was shown using dynasore, an inhibitor that blocks clathrin- and caveolin-dependent endocytosis. Depletion of MALAT1 in hADSC with antisense oligonucleotides resulted in exosomes without MALAT1. These exosomes had an effect similar to the unconditioned, control media in ECIS assays. Innovation: Exosomes contain lncRNA MALAT1 and other factors that have the potential to stimulate HDF cell migration and angiogenesis involved in wound healing without applying stem cells to wounds. Conclusion: Our results show the potential of using topically applied ADSC-derived exosomes containing MALAT1 for treating ischemic wounds. This allows for harnessing the power of stem cell paracrine signaling capabilities without applying the cells.
112 citations
TL;DR: Bacterial aggregates were observed at the edges of acute epidermal wounds, indicating initiated establishment of a biofilm.
Abstract: Objective: The bacterial composition and distribution were evaluated in acute standardized epidermal wounds and uninjured skin by a molecular in situ technology benchmarked to conventional culturing This was done to reveal whether bacterial biofilm is present in acute wounds Approach: On the buttock of 26 healthy volunteers, 28 suction blisters were made and de-roofed Four wounds were biopsied immediately after wounding, whereas the remaining 24 wounds were treated daily with sterile deionized water and covered with a moisture-retaining dressing On day 4 post-wounding, swabs were obtained for culturing from the wounds and adjacent skin, and the wounds including adjacent skin were excised Tissue sections were stained with peptide nucleic acid (PNA) fluorescence in situ hybridization (FISH) probes, counterstained by 4′,6-diamidino-2-phenylindole, and evaluated by confocal laser scanning microscopy (CLSM) Results: No bacterial aggregates were detected at day 0 At day 4, coagulase-negative staphylococc
45 citations
TL;DR: Three-dimensional bioprinting is a layer-based approach to regenerative medicine, whereby cells and cell-based materials can be dispensed in fine spatial arrangements to mimic native tissue to repair skin tissue damage.
Abstract: Significance: Skin tissue damage is a major challenge and a burden on healthcare systems, from burns and other trauma to diabetes and vascular disease. Although the biological complexities are relatively well understood, appropriate repair mechanisms are scarce. Three-dimensional bioprinting is a layer-based approach to regenerative medicine, whereby cells and cell-based materials can be dispensed in fine spatial arrangements to mimic native tissue. Recent Advances: Various bioprinting techniques have been employed in wound repair-based skin tissue engineering, from laser-induced forward transfer to extrusion-based methods, and with the investigation of the benefits and shortcomings of each, with emphasis on biological compatibility and cell proliferation, migration, and vitality. Critical issues: Development of appropriate biological inks and the vascularization of newly developed tissues remain a challenge within the field of skin tissue engineering. Future Directions: Progress within bioprinting requires close interactions between material scientists, tissue engineers, and clinicians. Microvascularization, integration of multiple cell types, and skin appendages will be essential for creation of complex skin tissue constructs.
35 citations
TL;DR: This data indicates that noncoding RNAs are critical regulators in processes such as angiogenesis and cutaneous cell migration and proliferation, including classically described biological pathways previously attributed to mostly protein constituents.
Abstract: Significance: Wound healing requires a highly orchestrated coordination of processes that are not yet fully understood. Therefore, available clinical therapies are thus far limited in their efficacy in preventing and treating both chronic wounds and scars. Current gene-based therapeutics is largely based on our understanding of the protein-coding genome and proteins involved in known wound healing pathways. Recent Advances: Noncoding RNAs such as microRNAs and long noncoding RNAs have recently been found to be significant modulators of gene expression in diverse cellular pathways. Research has now implicated noncoding RNAs in nearly every stage of the wound healing process, suggesting that they may serve as clinical therapeutic targets. Noncoding RNAs are critical regulators in processes such as angiogenesis and cutaneous cell migration and proliferation, including classically described biological pathways previously attributed to mostly protein constituents. Critical Issues: The complexity and diversity ...
35 citations
TL;DR: This observational study discusses the importance of reporting at the population level, specific wound etiology level, a risk-stratified level, and to then overlay the effect of treatment adherence on those outcomes to provide clinicians with a comprehensive understanding of when to prescribe an advanced modality such as hyperbaric oxygen.
Abstract: Objective: The goal of this research was to identify a population of diabetic foot ulcer patients who demonstrate a significant response to hyperbaric oxygen therapy (HBOT) using a large sample size to provide guidance for clinicians when treating these complicated patients. Approach: The effect of HBOT on diabetic foot ulcers, Wagner grades 3 and 4, was evaluated using a retrospective observational real-world data set. The study reported on the overall healing rate, (74.2%) at the population level, for >2 million wounds. Results: When a subgroup of patients of only foot ulcers with a Wagner grade 3 or 4 were considered, the healing rate was only 56.04%. The use of HBOT, without filtering for the number of treatments received, improved the healing rate to 60.01% overall. Healing rates for this same subgroup, however, were improved to 75.24% for patients who completed the prescribed number of hyperbaric treatments. Innovation: This observational study discusses the importance of reporting at the population level, specific wound etiology level, a risk-stratified level, and to then overlay the effect of treatment adherence on those outcomes to provide clinicians with a comprehensive understanding of when to prescribe an advanced modality such as hyperbaric oxygen. Conclusion: The authors provide healing outcomes data from several prior HBOT studies as well as other advanced modalities that have been used in diabetic foot ulcer care for comparison and context.
28 citations
TL;DR: Clinical recurrence of CLI is associated with a high rate of nonhealing ulcer recurrence, major amputation, and death, and Dialysis and impaired glycemic control were independent predictors of CLI relapse after endovascular treatment.
Abstract: Objective: To establish the rate of clinical recurrence of critical limb ischemia (CLI) in diabetic patients with ischemic foot ulcers (DFUs) treated by percutaneous transluminal angioplasty (PTA). Approach: The study group was composed of 304 patients with ischemic DFUs treated by PTA. We evaluated the rate of clinical recurrence of CLI requiring a second PTA (repeated PTA [rePTA]), the factors related to CLI relapse, and the outcomes of rePTA patients. The follow-up was 12.5 ± 6.6 months. Results: Seventy-four of 304 patients (24.3%) needed rePTA. The mean time to rePTA was 3.5 ± 0.64 months. rePTA group in comparison with no rePTA group had lower rate of healing (28.5% vs. 71.9% p = 0.0001), higher rate of ulcer recurrence (20% vs. 10.3% p = 0.03), major amputation (24.3% vs. 4.3% p = 0.0005), and death (33.3% vs. 7.9% p = 0.002). Glycated hemoglobin, type A1C (HbA1c; 2.2 [1.9-2.7] p = 0.02) and dialysis (1.5 [1.4-3.6] p = 0.006) were independently associated to clinical recurrence of CLI after PTA. Innovation: To identify the outcomes of patients with clinical recurrence of CLI and the clinical factors involved to reduce the rate of restenosis after endovascular treatment and improve the rate of limb salvage. Conclusions: Clinical recurrence of CLI is associated with a high rate of nonhealing ulcer recurrence, major amputation, and death. Dialysis and impaired glycemic control were independent predictors of CLI relapse after endovascular treatment.
20 citations
TL;DR: This study evidenced that this device manages to harvest FTSGs with minimal associated pain, and future research will need to evaluate other aspects of the procedure as well as long-term outcomes at the donor and recipient areas.
Abstract: Background: Despite the development of numerous wound treatment alternatives, 25% to 50% of leg ulcers and >30% of foot ulcers are not fully healed after 6 months of treatment. Autologous skin graf...
17 citations
TL;DR: A new highly diluted acetylcholine (Ach) formulation obtained through a sequential kinetic activation (SKA) method is evaluated to verify the hypothesis that a low dose of Ach could be a more physiological stimulus for healing, by stimulating muscarinic and nicotinic receptors and their related intracellular pathways.
Abstract: Objective: Wound healing is a dynamic, interactive, and complex process that involves a series of events, including inflammation, migration, proliferation, granulation tissue formation, and matrix ...
15 citations
TL;DR: VACi showed its effectiveness in timely infection eradication before spinal hardware instrumentation and with postoperative spine hardware salvage, demonstrating that VACi can provide infection eradications both preoperatively in high-risk surgical sites, facilitating necessary hardware implementation and post operatively in situations of hardware salvage.
Abstract: Objective: Infection prevention in spinal surgeries involving implantation of hardware is of utmost priority. Furthermore, successful eradication of infection in hardware salvage is likewise critical in maintaining the long-term retention of the spinal hardware construct. Approach: We report a retrospective case series of three cases where the utilization of a VAC with instillation (VACi) in conjunction with surgical debridement aided in infection control and eradication for both preimplantation and hardware salvage spine patients. Results: Three patients were included. In case 1, VACi was utilized in conjunction with surgical debridement and IV antibiotics in the setting of acute preoperative infection to eradicate infection and enable necessary spinal hardware implementation. Cases 2 and 3 are representative of VACi for salvage of exposed spinal hardware in both the early and delayed infection presentation settings. In both cases, patients developed postoperative infections following spinal instrumentation VACi was utilized in conjunction with surgical debridement and IV antibiotics. Hardware removal was avoided in both cases. All three patients healed completely without residual evidence of infection. Innovation: VACi showed its effectiveness in timely infection eradication before spinal hardware instrumentation and with postoperative spine hardware salvage. Conclusion: This case series demonstrates that VACi can provide infection eradication both preoperatively in high-risk surgical sites, facilitating necessary hardware implementation and postoperatively in situations of hardware salvage.
15 citations
TL;DR: The results presented here show that functional attributes, indications, and patient results are not always dictated by dressing substrates, and support the author's assertion that evidence-based wound management requires guidelines and recommendations that categorize advanced dressings based upon how they function in real-life settings, rather than upon their base substrate.
Abstract: Objective: Wound management recommendations usually group dressings by base substrate material or reimbursement codes, even when functional differences are vast (e.g., honey-containing alginates, super-absorbent hydrogels). Polymeric membrane dressings (PMDs) diverge dramatically from conventional foam dressings in functional attributes, indications, and patient results, providing an opportunity to demonstrate the evidence for categorizing dressings based upon functional differences. Approach: A search of ALL published literature describing the use of PMDs, with no date or language limits, was conducted. Documents simply listing a PMD brand name (e.g., PolyMem) as one of many "foam" dressings were eliminated. The subset of evidence evaluating PMDs for tissue damage resulting from pressure (pressure ulcers, pressure injuries, henceforth: PUs) was summarized. Results: Studies of PMDs, primarily from independent clinician-researchers, have accumulated into a significant evidence base over the past 30 years. PMDs actively cleanse and debride wounds, balance moisture, relieve pain, and limit inflammation: all functions not shared by conventional foams. Innovation: This article supports a paradigm shift for wound management guidance materials to embrace a more evidence-based, patient-centered method of classifying products. The results presented here, using PMDs for PUs as an example, show that functional attributes, indications, and patient results are not always dictated by dressing substrates. Rather than being comparable with conventional foam dressings, PMDs have substantially enhanced functions and results. Conclusion: These results strongly support the author's assertion that evidence-based wound management requires guidelines and recommendations that categorize advanced dressings based upon how they function in real-life settings, rather than upon their base substrate.
TL;DR: Splinting full-thickness cutaneous wounds in mice has allowed for a humanized model of wound healing, and delineating the epithelial edge and assessing time to closure of these healing wound...
Abstract: Objective: Splinting full-thickness cutaneous wounds in mice has allowed for a humanized model of wound healing. Delineating the epithelial edge and assessing time to closure of these healing wound...
TL;DR: DFO-TDDS significantly accelerates healing of murine SCUs by chelation of excessive free iron and is currently manufactured in an FDA-compliant facility to be translated for treating human SCUs.
Abstract: Objective: Sickle cell ulcers (SCUs) are a devastating comorbidity affecting patients with sickle cell disease (SCD). SCUs form over the medial or lateral malleoli of the lower extremity, are slow ...
TL;DR: Pro-lymphangiogenic therapies that aim at the acceleration of tissue healing should focus on the controlled administration of VEGF-C to increase their capillary specificity, whereas regeneration of collecting vessels might benefit from balanced maturation and differentiation of pre-existing lymphatics.
Abstract: Significance: Growth of distinctive blood vessels of granulation tissue is a central step in the post-developmental tissue remodeling. Even though lymphangiogenesis is a part of the regeneration process, the significance of the controlled restoration of lymphatic vessels has only recently been recognized. Recent Advances: Identification of lymphatic markers and growth factors paved the way for the exploration of the roles of lymphatic vessels in health and disease. Emerging pro-lymphangiogenic therapies use vascular endothelial growth factor (VEGF)-C to combat fluid retention disorders such as lymphedema and to enhance the local healing process. Critical Issues: The relevance of recently identified lymphatic functions awaits verification by their association with pathologic conditions. Further, despite a century of research, the complete etiology of secondary lymphedema, a fluid retention disorder directly linked to the lymphatic function, is not understood. Finally, the specificity of pro-lymphangiogenic...
TL;DR: Both CCO and silver-containing products promote significant reduction in DFU area over 6 weeks of treatment with no clinically relevant safety concerns.
Abstract: Objective: To compare outcomes of diabetic foot ulcers (DFUs) treated with clostridial collagenase ointment (CCO) or silver-containing products, both in combination with sharp debridement as needed. Approach: One hundred two subjects with qualifying DFUs were randomized to daily treatment with either CCO or a silver-containing product for 6 weeks followed by a 4 -week follow-up period. The primary outcome was the mean percent reduction in DFU area. A secondary outcome was the incidence of ulcer infections between groups. Results: At the end of treatment, the mean percent reduction in area from baseline of DFUs treated with CCO was 62% (p < 0.0001) and with silver was 40% (p < 0.0001). The difference between groups—22%—was not statistically significant (p = 0.071). Among ulcers closed by the end of treatment, the mean time to closure was 31.1 ± 9.0 days versus 37.1 ± 7.7 days, respectively (not statistically significant). There was a numerically greater incidence of target ulcer infections in the silver gr...
TL;DR: This study evaluated the efficacy of a concentrated surfactant-based wound dressing on wound repair, by investigating their ability to enhance human dermal fibroblast proliferation and viability and a direct cytotoxicity assay and a 3D keratinocyte-fibroblast model were employed.
Abstract: Objective: This study was set up to evaluate the efficacy of a concentrated surfactant-based wound dressing (with and without silver sulfadiazine [SSD]) on wound repair, by investigating their ability to enhance human dermal fibroblast proliferation and viability. In addition, the wound dressings were evaluated for their ability to suppress biofilms in a three-dimensional (3D) in vitro wound biofilm model and modulate the inflammatory cytokine interleukin-6 (IL-6) and tumor necrosis factor-alpha (TNFα). Approach: Problematic biofilms are well known to affect fibroblast and keratinocyte viability. To assess wound repair and inflammatory cytokine modulation, a direct cytotoxicity assay and a 3D keratinocyte-fibroblast model were employed. Results: At 1 and 7 days posttreatment, the non-antimicrobial dressing was noncytotoxic and the antimicrobial dressing was moderately cytotoxic to adult human dermal fibroblasts cells. Within the 3D wound model, the biofilm demonstrated a decelerating effect on wound closu...
TL;DR: An overview of comparative effectiveness research (CER) methodology and the challenges of health economics and outcomes research (HEOR) in wound care are discussed and several CER approaches in observational studies provide sufficiently detailed information to help decision-makers make informed choices about wound care products regarding efficacy in the real-world setting.
Abstract: Objective: To provide an overview of comparative effectiveness research (CER) methodology and discuss the challenges of health economics and outcomes research (HEOR) in wound care. Approach: Narrative description of HEOR methodology with supporting references. Results: With the increasing costs of clinical trials, the use of observational studies in a real-world setting will be essential. Wound care clinicians should understand the importance of proper methods for conducting CER studies. Propensity score methods and marginal structural modeling can create a "quasi-randomized" environment for measuring wound closure and can help drive informed decision-making. In wound care, a paucity of HEOR information is available with great reluctance to use this information by payers, the Food and Drug Administration, the Centers for Medicare & Medicaid Services, and other agencies. Furthermore, a limited amount of high-quality retrospective data to measure wound care outcomes exist. The U.S. Wound Registry is one of few data sources that accurately reports on outcomes for all wound types and is a Qualified Clinical Data Registry. Innovation and Conclusions: Several CER approaches in observational studies provide sufficiently detailed information to help decision-makers make informed choices about wound care products regarding efficacy in the real-world setting. Using CER and cost-effectiveness studies succinctly needs to be incorporated if progress is to be made in improving wound care outcomes and reducing cost.
TL;DR: The longer the application time, the better for organization and aggregation of collagen fibers in the rat tendon, according to the results of this study.
Abstract: Objective: The aim of this study was to evaluate the organization of collagen fibers in the healing process of rat Achilles tendon rupture using different times of ultrasound therapy (TUS). Approac...
TL;DR: Fetuses early in gestation heal skin wounds without forming scars by using fibroblasts, which are cells known to be intimate cells that communicate with each other.
Abstract: Objective: Fetuses early in gestation heal skin wounds without forming scars. The biological mechanisms behind this process are largely unknown. Fibroblasts, however, are cells known to be intimate...
TL;DR: The results show that the "true" cost-to-heal DFUs strongly depend on the method used to calculate the costs, and the reimbursement-based costing method may not accurately reflect real costs.
Abstract: Objective: The aim of the study was to illustrate the differences in the cost-to-heal wounds using two methods: (1) reimbursement-based costing and (2) activity-based costing (ABC). Approach: A sma...
TL;DR: Wound care practitioners can participate in a QCDR for MIPS credit, which enables them to optimize their MIPS score, particularly if they transmit data directly from their EHR, and utilize structured data for comparative effectiveness research.
Abstract: Significance: Wound care practitioners have no professional society to promote participation in a Qualified Clinical Data Registry (QCDR), which is essential to thrive under the Merit-Based Incentive Payment System (MIPS), and until recently have lacked relevant quality measures to report. Practitioners can now participate in the nonprofit U.S. Wound Registry (USWR) QCDR for MIPS credit, which can receive data from any certified electronic health record (EHR) and, in so doing, generate data useful for comparative effectiveness research. Recent Advances: For 2018, the Centers for Medicare and Medicaid Services (CMS) has approved 12 wound care and hyperbaric medicine-relevant quality measures and several clinical practice Improvement Activities, which can be reported for MIPS credit through the USWR. Several QCDR measures have met the CMS 3-year reporting criteria to establish national benchmark rates, likely enabling practitioners to achieve higher quality scores than possible with standard MIPS measures. The structured registry data generated have been harnessed to evaluate adherence to evidence-based clinical practice guidelines, understand real-world patient healing rates, and demonstrate the comparative effectiveness of wound therapies. Critical Issues: Wound care practitioners can participate in a QCDR for MIPS credit, which enables them to optimize their MIPS score, particularly if they transmit data directly from their EHR. Utilizing structured data for comparative effectiveness research may help ensure patient access to advanced therapeutics. Future Directions: By 2019, to overcome technological barriers to participation, USWR quality measures will be available as "apps" for EHRs that support the interface required to achieve the next stage of EHR certification as part of the open Application Programming Initiative.
TL;DR: Examining expression profiles of fetal and postnatal wounds utilizing updated gene annotations and pathway analysis to further delineate between repair and regeneration recognizes hundreds of possible genes as candidates for regulators of scarless versus scarring wound repair.
Abstract: Objective: In early gestation, fetal wounds heal without fibrosis in a process resembling regeneration. Elucidating this remarkable mechanism can result in tremendous benefits to prevent scarring. ...
TL;DR: Impaired initiation of wound repair by oligodendrocyte precursor cells or oligodENDrocytes may play a role in MS, and a lack of inhibition of the proliferative phase in wound healing may explain the pathophysiology involved in Pso.
Abstract: Significance: Better understanding of wound healing could lead to improved treatment(s) of multiple sclerosis (MS) and psoriasis (Pso). Recent Advances: New concepts in the events of wound healing, such as the roles of the innate and adaptive immune systems, have generated targets for treating these debilitating diseases. Innovation: That in MS and Pso defective wound healing is responsible for the diseases' progression has not been hypothesized to date. Conclusion: Impaired initiation of wound repair by oligodendrocyte precursor cells or oligodendrocytes may play a role in MS, and a lack of inhibition of the proliferative phase in wound healing may explain the pathophysiology involved in Pso.
TL;DR: A national network of electronic health records can effectively identify a large number of patients with sickle cell ulcers to support analysis of epidemiology, healing patterns, and health care utilization.
Abstract: Objective: Sickle cell ulcers affect as many as 15% of patients with sickle cell disease in the United States and severely impact quality of life. An understanding of baseline healing patterns is important to inform study design for future trials that test therapies for this disease. Approach: In this study, an electronic wound management system was leveraged to analyze retrospective data on 133 unique sickle cell patients who were treated across 114 wound healing centers, and to describe their characteristics and healing patterns as compared with those of venous ulcer patients. The data included 198 care episodes for 427 wounds. Results: Patients with sickle cell ulcers were younger and had fewer comorbid diseases than those with venous ulcers. Larger size and longer duration were predictors of poor healing. Between the first and fourth assessments, mean change in area for sickle cell ulcers showed a 58% increase, compared with a 13% decrease for venous ulcers. Kaplan-Meier curves showed poorer healing in sickle cell ulcers than in venous ulcers across all categories of size and duration. Patients with sickle cell ulcers had longer care episodes and were more likely to re-present for care. Innovation: This study reports on the largest data set of sickle cell ulcer patients analyzed to date in the published literature to provide a more detailed understanding of wound healing patterns of this disease. Conclusion: A national network of electronic health records can effectively identify a large number of patients with sickle cell ulcers to support analysis of epidemiology, healing patterns, and health care utilization.
TL;DR: The value of using a team to obtain adequate and correct reimbursement and the wisdom of engaging reimbursement strategy experts, key opinion leaders, professional medical specialty societies, Medical Advisory Boards, and revenue cycle personnel early in the development cycle of new products and in the creation of outpatient wound care businesses are described.
Abstract: Wound care manufacturers, hospital outpatient wound care provider-based departments, physicians, and other qualified health care professionals often underestimate the time and energy that should be devoted toward the components of reimbursement (coding, payment, and coverage) that pertain to their technology and their businesses. In addition, they often attempt to leap the reimbursement hurdles by themselves. This article (1) describes the value of using a team to obtain adequate and correct reimbursement and (2) emphasizes the wisdom of engaging reimbursement strategy experts, key opinion leaders, professional medical specialty societies, Medical Advisory Boards, and revenue cycle personnel early in the development cycle of new products and in the creation of outpatient wound care businesses.
TL;DR: Quantitative parameters of dermal wound healing, obtained from noninvasive fine-sampled photographic data, identify topical FGF-1 as an effective therapeutic to treat the senescence of Dermal healing present in aged female BALB/cByJ mice.
Abstract: Objective: To determine quantitative parameters of dermal wound healing senescence in aged BALB/cByJ mice (an important animal model of aging) and to evaluate the potential for therapeutic intervention by fibroblast growth factor-1 (FGF-1). Approach: Utilize a novel noninvasive fine-sampled photographic methodology to quantify wound healing parameters for healing phases from wounding through to wound closure. Results: Parameters associated with key healing phases were quantified and compared between nonaged and aged cohorts of both genders. The results identify a sexual dimorphism in dermal wound healing, with nonaged females exhibiting a greater overall healing efficiency than males. This enhanced healing in females, however, senesces with age such that healing parameters for aged males and females are statistically indistinguishable. Topical application of FGF-1 was identified as an effective therapeutic intervention to treat dermal healing senescence in aged females. Innovation: The FGF intervention is being analyzed using a new recently published model. This approach significantly increases the amount of preclinical animal data obtainable in wound healing studies, minimizes cohort number compared with (lethal) histological studies, and permits a direct statistical comparison between different healing studies. Conclusion: Quantitative parameters of dermal wound healing, obtained from noninvasive fine-sampled photographic data, identify topical FGF-1 as an effective therapeutic to treat the senescence of dermal healing present in aged female BALB/cByJ mice.
TL;DR: This study suggests that the use of a SBD increases the tolerability of nylon sutures in porcine acute skin wound closures allowing for prolonged mechanical support of the wound for slow healing wounds.
Abstract: Objective: To compare the tolerability and mechanical tensile strength of acute skin wounds closed with nylon suture plus a novel suture bridge device (SBD) with acute skin wounds closed with nylon suture in a porcine model. Approach: Four Yucatan pigs each received 12 4.5 cm full-thickness incisions that were closed with 1 of 4 options: Suture bridge with nylon, suture bridge with nylon and subdermal polyglactin, nylon simple interrupted, and nylon simple interrupted with subdermal polyglactin. Epithelial reaction, inflammation, and scarring were examined histologically at days 10 and 42. Wound strength was examined mechanically at days 10 and 42 on ex vivo wounds from euthanized pigs. Results: Histopathology in the suture entry/exit planes showed greater dermal inflammation with a simple interrupted nylon suture retained for 42 days compared with the SBD retained for 42 days (p < 0.03). While tensile wound strength in the device and suture groups were similar at day 10, wounds closed with the devices we...
TL;DR: The strategy and activities that companies should undertake before applying for a new HCPCS code, and key milestones in theHCPCS coding process, are addressed.
Abstract: Obtaining an appropriate Healthcare Common Procedure Coding System (HCPCS) code for a new product is the first step in a successful reimbursement strategy. However, applying for a new HCPCS code ca...
TL;DR: Researchers and developers should simultaneously plan for FDA clearance and reimbursement from the product's inception and seek the help and guidance of professional medical associations to navigate the Current Procedural Terminology.
Abstract: Every day products and their accompanying procedures are delivered to the marketplace and touted to aid physicians and other qualified health care professionals (QHPs) in taking care of patients who have chronic wounds. Some of these products/procedures have been developed with the patient in mind and with a serious regulatory and reimbursement strategy, and other products/procedures make physicians, other QHPs, and payers scratch their heads about the true purpose of the product/procedure. Researchers and developers often only focus on gaining Food and Drug Administration (FDA) clearance and often plunge into the marketplace unaware of the reimbursement stumbling blocks that can prevent the expected market acceptance. Researchers and developers should simultaneously plan for FDA clearance and reimbursement from the product's inception. If a product/procedure requires a new procedure code, researchers and manufacturers should seek the help and guidance of professional medical associations to navigate the Current Procedural Terminology (CPT®; CPT is a registered trademark of the American Medical Association), to make available useful new products/procedures for appropriate patients and to adequately reimburse the physician and other QHPs.