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Objective: To identify how cellular and/or tissue-based products (CTPs) relate to value in terms of cost per quality-adjusted life years (QALYs) in wound care in comparison with treatments in other medical fields. Approach: This is a cross-sectional study and a cost-effectiveness analysis. Payment limits for each CTP were obtained via the Healthcare Common Procedure Coding System Q codes and formulated as cost inputs into a cost-utility model published for treatment of Wagner 1 diabetic foot ulcers using dehydrated human amnion and chorion allograft versus standard of care (SOC). Additional changes to cap the number of CTP applications and adjustments for recent inflation were made. The literature was searched for other cost-utility models in other diabetes-related diseases as a comparison. Results: When the payment limit was ≤$140 per square centimeter, interventions were dominant (less costly, better outcomes) compared with SOC. When the limit exceeded $430 per square centimeter, the cost-effectiveness threshold of $100,000/QALY was exceeded. Newer Q codes are generally much more expensive and likely to not be cost-effective, similar to the results for many other chronic diabetes-related diseases . Innovation: This study presents decision makers with tools, by which they can determine as to whether a given CTP is likely to be cost-effective for patients. Conclusion: Over a third of all CTPs will very likely result in noncost-effective interventions. This number is likely to be higher when wounds are larger or used in other wound types where they are less efficacious. The recent trend in much higher costs for CTPs is worrisome.
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BACKGROUND: Environmental disinfection is essential for reducing spread of healthcare associated infections (HAIs). Previous studies report conflicting results regarding the effects of ultraviolet light (UV) in reducing infections. This trial evaluated the impact of adding pulsed xenon UV (PX-UV) to standard terminal cleaning in reducing environmentally-implicated HAIs (eiHAIs). METHODS: The LAMP trial was conducted in 2 hospitals (15 inpatient wards) utilizing a cluster randomized controlled, double-blinded, interventional crossover trial comparing standard terminal cleaning followed by either pulsed xenon ultraviolet (PX-UV) disinfection (intervention arm) or sham disinfection (control arm). The primary outcome was incidence of eiHAIs from clinical microbiology tests on the 4th day of stay or later or within 3 days after discharge from the study unit. EiHAIs included clinical cultures positive for vancomycin-resistant enterococci (VRE), extended spectrum beta-lactamase-producing Escherichia coli or Klebsiella pneumonia, methicillin-resistant Staphylococcus aureus (MRSA), and Acinetobacter baumannii, and stool PCR positive for Clostridiodes difficile. FINDINGS: Between May 18, 2017 to Jan 7, 2020, 25,732 patients were included, with an incidence of 601 eiHAI and 180,954 patient days. There was no difference in the rate of eiHAIs in the intervention and sham arms (3.49 vs 3.17 infections/1000 patient days respectively, RR 1.10 CI (0.94, 1.29, p= 0.23)). Study results were similar when stratified by eiHAI type, hospital, and unit type. CONCLUSION: The LAMP study failed to demonstrate an effect of the addition of UV light disinfection following terminal cleaning on reductions in rates of eiHAIs. Further investigations targeting hospital environmental surfaces and the role of no touch technology to reduce HAIs are needed.
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As the incidence of diabetic foot ulcers (DFU) increases, better treatments that improve healing should reduce complications of these ulcers including infections and amputations. We conducted a randomized controlled trial comparing outcomes between a novel purified reconstituted bilayer membrane (PRBM) to the standard of care (SOC) in the treatment of non-healing DFUs. This study included 105 patients who were randomized to either of two treatment groups (n = 54 PRBM; n = 51 SOC) in the intent to treat (ITT) group and 80 who completed the study per protocol (PP) (n = 47 PRBM; n = 33 SOC). The primary endpoint was the percentage of wounds closed after 12 weeks. Secondary outcomes included percent area reduction, time to healing, quality of life, and cost to closure. The DFUs that had been treated with PRBM healed at a higher rate than those treated with SOC (ITT: 83% vs. 45%, p = 0.00004, PP: 92% vs. 67%, p = 0.005). Wounds treated with PRBM also healed significantly faster than those treated with SOC with a mean of 42 versus 62 days for SOC (p = 0.00074) and achieved a mean wound area reduction within 12 weeks of 94% versus 51% for SOC (p = 0.0023). There were no adverse events or serious adverse events that were related to either the PRBM or the SOC. In comparison to the SOC, DFUs healed faster when treated with PRBM. Thus, the use of this PRBM is an effective option for the treatment of chronic DFUs.
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Diabetes Mellitus , Pie Diabético , Humanos , Pie Diabético/cirugía , Estudios Prospectivos , Calidad de Vida , Nivel de Atención , Resultado del Tratamiento , Cicatrización de HeridasRESUMEN
Aim: Posterior cranial fossa (PCF) surgery is associated with complications, including cerebrospinal fluid (CSF) leakage. Dural sealants such as polyethylene glycol (PEG)-based hydrogels and fibrin glue can prevent CSF leaks, with evidence suggesting PEG hydrogels may outperform fibrin glue. However, the budget impact of using PEG hydrogels in PCF surgeries in Europe is unclear. Materials & methods: A decision tree was developed based on a previous US model, to assess the budget impact of switching from fibrin glue to PEG hydrogel in PCF surgery across five European countries. Input costs were derived from published sources for the financial year 2022/2023. Health outcomes, including CSF leaks, were considered. Results: The model predicted that using PEG hydrogel instead of fibrin glue in PCF surgery can lead to cost savings in five European countries. Cost savings per patient ranged from EUR 419 to EUR 1279, depending on the country. Sensitivity analysis showed that the incidence of CSF leaks and pseudomeningoceles had a substantial impact on the model's results. Conclusion: PEG hydrogels may be a cost-effective alternative to fibrin glue in PCF surgery. The model predicted that cost savings would be mainly driven by a reduction in the incidence of postoperative CSF leaks, resulting in reduced reliance on lumbar drains, reparative surgery and shortened hospital stays.
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Rinorrea de Líquido Cefalorraquídeo , Adhesivo de Tejido de Fibrina , Humanos , Adhesivo de Tejido de Fibrina/uso terapéutico , Procedimientos Neuroquirúrgicos/efectos adversos , Procedimientos Neuroquirúrgicos/métodos , Pérdida de Líquido Cefalorraquídeo/prevención & control , Pérdida de Líquido Cefalorraquídeo/etiología , Rinorrea de Líquido Cefalorraquídeo/etiología , Rinorrea de Líquido Cefalorraquídeo/prevención & control , Complicaciones Posoperatorias/epidemiología , HidrogelesRESUMEN
In 2022, the Alliance of Wound Care Stakeholders convened the 2-day Wound Care Evidence Summit™. The Summit brought together a multidisciplinary group of stakeholders that included payers, government agency policymakers, prominent researchers, wound care medical specialty societies, patient and clinical associations, wound care clinics, and manufacturers to discuss wound care evidence and coverage issues. The Summit focused on a wide variety of wound care topics, with an emphasis on the processes payers use to create their coverage policies and the type, quantity, and characteristics of clinical evidence payers require. The most valuable outcome of the Summit was the frank and open discourse among stakeholders, with unprecedented participation from payers and the U.S. Food and Drug Administration (FDA) on the subjects of trial design, product-approval pathways, and coverage policy determination. Stakeholders provided actionable ideas for ways to improve clinical trial research and design that will yield better evidence and ultimately better wound care. This article examines the quality, adequacy, and relevance of the existing chronic wound care research base and discusses the gaps, associated problems, and implications for clinical trial design and execution as identified by Summit participants.
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Medicina Basada en la Evidencia , Heridas y Lesiones , Humanos , Heridas y Lesiones/terapia , Estados Unidos , Cicatrización de Heridas , Congresos como AsuntoRESUMEN
Background: Diabetic foot ulcers (DFUs) pose a significant clinical challenge for providers and patients, and often precede devastating complications such as infection, hospitalization, and amputation. Therefore, advanced treatment options are needed to facilitate the healing of chronic DFUs and improve outcomes in this high-risk population. Cryopreserved viable human amnion membrane allograft (vHAMA) has shown great promise in the treatment of recalcitrant DFUs as a supplement to standard of care (SOC). Placental grafts are rich in extracellular matrix proteins, growth factors, and cytokines, which can induce angiogenesis and dermal fibroblast proliferation, resulting in accelerated healing. Methods: In this prospective, multicenter single arm trial, 20 patients with nonhealing DFUs received weekly application of vHAMA, in addition to SOC, for up to 12 weeks. The primary study endpoint was proportion of healed wounds at 12 weeks. Secondary endpoints included proportion of wounds healed at 6 weeks, time to heal, and percentage area wound reduction. Subjects were evaluated for ulcer healing and assessed for adverse events at every treatment visit. Results: At study conclusion, 85% of patients receiving vHAMA healed. Ten wounds healed (50%) by 6 weeks, and 17 wounds (85%) healed by 12 weeks. The mean time to heal was 46.6 days (95% CI: 35.1-58.0), and the average number of vHAMAs used was 5.4 (SD: 3.25). The mean PAR was 86.3% (SD: 40.51). Conclusions: Aseptically processed, cryopreserved vHAMA should be considered as a safe and effective option for DFUs refractory to SOC therapy.
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Significance: Quality of life (QoL) is important to patients with chronic wounds and is rarely formally evaluated. Understanding what comorbidities most affect the individual versus their wounds could be a key metric. Recent Advances: The last 20 years have seen substantial advances in QoL instruments and conversion of patient data to a single value known as the health utilities index (HUI). We review these advances, along with wound-related QoL, and analyze real-world comorbidities challenging wound care. Critical Issues: To understand the impact of underlying comorbidities in a real-world patient population, we examined a convenience sample of 382 patients seen at a hospital-based outpatient wound center. This quality reporting study falls outside the regulations that govern human subject research. Comorbid conditions were used to calculate HUIs using a variety of literature-reported approaches, while Wound-Quality-of-Life (W-QoL) questionnaire data were collected from patients during their first visit. The mean number of conditions per patient was 8; 229 patients (59.9%) had utility values for comorbidities/conditions, which were worse/lower than their wounds' values. Sixty-three (16.5%) patients had depression and/or anxiety, 64 (16.8%) had morbid obesity, and 204 (53.4%) had gait and mobility disorders, all of which could have affected W-QoL scoring. The mean minimum utility value (0.5) was within 0.05 units of an average of 13 studies reporting health utilities from wound care populations using the EuroQol 5 Dimension instrument. Future Directions: The comorbidity associated with the lowest utility value is what might most influence the QoL of patients with chronic wounds. This finding needs further investigation.
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Calidad de Vida , Humanos , Encuestas y CuestionariosRESUMEN
Purpose: Small observational studies suggest subclinical disease occurrence in the normal-appearing scalp zones of several primary cicatricial alopecias. To aid patient management, we began routinely evaluating the entire scalp of patients with acne keloidalis nuchae (AKN), including trichoscopy-guided biopsies. Patients and Methods: This retrospective study evaluated 41 patients sequentially presenting with AKN at a single clinic between June and December 2022. Primary lesions and normal-appearing scalp in the superior parietal scalp at least 5 cm away from AKN-affected zones were clinically evaluated, and areas showing perifollicular erythema or scales/casts on trichoscopy were biopsied and histologically analyzed. Results: Forty-one men with AKN, including 20 men of African descent, 17 Hispanic, and 4 European-descended Whites, were evaluated. All patients, including 22% with associated folliculitis decalvans, showed scalp-wide trichoscopy signs of perifollicular erythema or scaling in normal-appearing scalp areas. All patients showed histologic evidence of perifollicular infundibulo-isthmic lymphocytoplasmic infiltrates and fibrosis (PIILIF), with 96% showing Vellus or miniaturized hair absence. PIILIF was often clinically mistaken for seborrheic dermatitis (44-51%). All White patients had mild papular acne keloidalis nuchae lesions mistaken for seborrheic dermatitis. Conclusion: PIILIF may be a precursor to a wide spectrum of primary cicatricial alopecias, including AKN and folliculitis decalvans. This finding carries implications for the early diagnosis and management of AKN and other primary cicatricial alopecias.
Acne keloidalis nuchae (AKN) is a type of hair loss and scalp condition marked by scarring and inflammation. This condition falls under a group of chronic hair and scalp issues known as primary cicatricial alopecia (PCA). Current treatments for AKN and similar PCAs often do not work well, and the condition tends to return. We have found a hidden scalp condition that could be causing AKN and other PCAs. It's a subtle disease that affects the entire scalp, even though it might not show noticeable symptoms. We have observed this condition in all 41 AKN patients in our study, and it's characterized by certain changes in the hair and scalp's structure and immune system response. Other studies have linked this condition to various other PCAs. We believe this hidden condition could be causing AKN and making it come back after treatment. This study suggests that treating AKN might require a broader approach beyond just treating the visible symptoms. Since this hidden condition exists in other PCAs, it might be a common cause.
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OBJECTIVE: To determine the cost of wound care and prevalence of chronic wounds for Medicare beneficiaries in the aggregate, by wound type, and by setting between the years 2014 and 2019. METHODS: This retrospective analysis of Medicare claims data included beneficiaries who experienced episodes of care for diabetic foot ulcers and infections; arterial ulcers; skin disorders and infections; surgical wounds and infections; traumatic wounds; venous ulcers and infections; unspecified chronic ulcers; and others. The 2014 data were based on a Medicare 5% Limited Data Set whereas for 2019 the data used were for all fee-for-service Medicare beneficiaries. Three methods were used to generate expenditure estimates: (a) a low (Medicare provider payments when the wound was a primary diagnosis, excluding any kind of deductible); (b) mid (primary plus secondary diagnosis with weighted attribution); and (c) high (primary or secondary diagnosis). The main outcomes were the prevalence of each wound type, Medicare expenditure for each wound type and aggregate, and expenditure by type of service. RESULTS: Over the 5-year period the number of Medicare beneficiaries with a wound increased from 8.2 million to 10.5 million. Wound prevalence increased by 13% from 14.5% to 16.4%. Over the 5-year period, the Medicare beneficiaries with the largest increase in chronic wound prevalence were those aged <65 years (males: 12.5% to 16.3%; females: 13.4% to 17.5%). The largest changes in terms of wound prevalence were increases in arterial ulcers (0.4% to 0.8%), skin disorders (2.6% to 5.3%), and decreases in traumatic wounds (2.7% to 1.6%). Expenditures decreased regardless of the three methods used with a reduction of $29.7 billion to $22.5 billion for the most conservative method. Except for venous ulcers in which costs per Medicare beneficiary increased from $1206 to $1803, cost per wound decreased with surgical wounds remaining the most expensive to treat (2014: $3566; 2019: $2504), and the largest decrease for arterial ulcers ($9651 to $1322). Hospital outpatient fees saw the largest reduction ($10.5 billion to $2.5 billion) although home health agency expenditures decreased from $1.6 billion to $1.1 billion. Physician offices saw an increase from $3.0 billion to $4.1 billion and durable medical equipment increased from $0.3 billion to $0.7 billion. CONCLUSIONS: It appears that chronic wound care expenditures have shifted to the physician's office from the hospital-based outpatient department. Given that the prevalence of chronic wounds is increasing, especially among the disabled under 65, it will be important to know whether these shifts have positively or negatively affected outcomes.
HighlightsIn 2014 chronic wounds impacted 14.5% of Medicare beneficiaries but this increased to 16.3% by 2019. The group of Medicare beneficiaries most affected in terms of chronic wound prevalence over the 5-year period were those aged <65 years (males: 12.5% to 16.3%; females: 13.4% to 17.5%). The largest changes in terms of prevalence were increases in arterial ulcers (0.4% to 0.8%), skin disorders (2.6% to 5.3%), and traumatic wounds (2.7% to 1.6%)Over the 5-year period, regardless of the method used, there was a decrease in chronic wound-related costs ($29.7 billion in 2014 to $22.5 billion in 2019 for the most conservative method: Medicare provider payments when the wound was a primary diagnosis, excluding any kind of deductible). Surgical complications still represent the largest wound category of costs with a small decrease from 2014 to 2019 of $6.1 billion to $5.9 billion. Based on the most conservative method, there was a very large cost reduction observed for outpatients from $10.5 billion to $2.5 billion with a correspondingly smaller decrease for inpatients of $5.3 billion to $4.2 billion, but an increase from $3.0 billion to $4.1 billion for physician offices. In addition, while durable medical equipment increased from $0.3 billion to $0.7 billion, home health agency expenditures decreased from $1.6 billion to $1.1 billion.Our data suggest that while most of the cost remains in the subacute setting it has shifted to the physician's office from the hospital-based outpatient department. Given the increasing prevalence of chronic wounds, especially among the disabled under 65, it will be important to know whether these shifts have positively or negatively affected outcomes.
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Herida Quirúrgica , Úlcera Varicosa , Masculino , Femenino , Humanos , Anciano , Estados Unidos , Medicare , Estudios Retrospectivos , Prevalencia , Gastos en SaludRESUMEN
Objective: To conduct a systematic review and meta-analysis of recently published randomized controlled trials (RCTs) that employed the use of topical oxygen therapy (TOT) as an adjunct therapy in the treatment of Wagner 1 and 2 diabetic foot ulcers. Approach: Following a literature search of eligible studies from 2010 onward, four RCTs were included. Studies were analyzed for patient and wound characteristics, outcomes, risk of bias, and quality of the evidence assessed using the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) methodology. A random-effects meta-analysis for complete wound healing was carried out due to statistical heterogeneity of included studies. Results: Risk of bias judgment (RoB2 analysis) resulted in one low-risk trial and three trials with some risk. One study was determined to be the origin of the statistical heterogeneity. Pooled results showed statistical significance with a risk ratio (RR) of 1.59 (95% confidence interval [CI]: 1.07-2.37; p = 0.021). Sensitivity analysis, based on imputed values for missing outcomes, demonstrated that both the RR and 95% CIs changed little. The GRADE ratings for each domain were as follows: (a) risk of bias: moderate (3); (b) imprecision: moderate (2), high (1); (c) inconsistency: low (2), high (1); (d) indirectness: moderate (2), high (1); and (e) publication bias: moderate (1), high (2). Overall, the evidence was moderate. Innovation: Our study shows that TOT is a viable diabetic foot ulcer therapy. Conclusions: These data support the use of TOT for the treatment of chronic Wagner 1 or 2 diabetic foot ulcers in the absence of infection and ischemia.
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Diabetes Mellitus , Pie Diabético , Úlcera del Pie , Humanos , Pie Diabético/terapia , Oxígeno , Cicatrización de HeridasRESUMEN
BACKGROUND: After laser resurfacing, it is imperative that an appropriate postoperative regimen is followed for optimal wound healing. There is currently no consensus about which agents should be used. OBJECTIVE: To evaluate the safety and efficacy of a novel macrophage-activating gel in a Phase 2B trial to be used after fractionated ablative laser resurfacing of the chest. MATERIALS AND METHODS: Forty-two adults who received fractionated CO2 laser resurfacing of the chest were randomized (active or placebo) for 5 consecutive days after procedure. Skin quality at baseline and follow-up was assessed by a blinded evaluator using the Fitzpatrick-Goldman Wrinkle Scale. Subject satisfaction with skin healing and quality was also assessed. RESULTS: At 28 days according to the Fitzpatrick-Goldman Wrinkle Scale, 85% of subjects achieved an improvement of at least 33% for the active group versus 50% in the placebo group (absolute difference 35%; p = .04). Similarly, 75% of subjects achieved an improvement score of at least 33% in elastosis in the active group versus 35% in the placebo group at 28 days (40% absolute difference; p = .011). CONCLUSION: This study confirms the potent effects of the novel macrophage-activating gel for optimization of skin healing and quality after laser resurfacing of the chest.
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Láseres de Gas , Adulto , Humanos , Láseres de Gas/efectos adversos , Cicatrización de Heridas , Piel , Tórax , MacrófagosRESUMEN
Purpose: The aim of this study was to develop a risk stratification system that predicts visual outcomes (uncorrected corrected visual acuity at one week and five weeks postoperative) in patients undergoing cataract surgery. Methods: This was a retrospective analysis in a multitier ophthalmology network. Data from all patients who underwent phacoemulsification or manual small-incision cataract surgery between January 2018 and December 2019 were retrieved from an electronic medical record system. There were 122,911 records; 114,172 (92.9%) had complete data included. Logistic regression analyzed unsatisfactory postoperative outcomes using a main effects model only. The final model was cross-checked using forward stepwise selection. The Hosmer-Lemeshow goodness of fit test, the Bayesian information criterion, and Nagelkerke's R2 assessed model fit. Dispersion was calculated from deviance and degrees of freedom and C-stat from receiving operating characteristics analysis. Results: The final phacoemulsification model (n = 48,169) had a dispersion of 1.08 with a Hosmer-Lemeshow goodness of fit of 0.20, a Nagelkerke R2 of 0.19, and a C-stat of 0.72. The final manual small-incision cataract surgery model (n = 66,003) had a dispersion of 1.05 with a Hosmer-Lemeshow goodness of fit of 0.00015, a Nagelkerke R2 of 0.14, and a C-stat of 0.68. Conclusion: The phacoemulsification model had reasonable model fit; the manual small-incision cataract surgery model had poor fit and was likely missing variables. The predictive capability of these models based on a large, real-world cataract surgical dataset was suboptimal to determine which patients could benefit most from sight-restoring surgery. Appropriate patient selection for cataract surgery in developing settings should still rely on clinician thought processes, intuition, and experience, with more complex cases allocated to more experienced surgeons.
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Extracción de Catarata , Catarata , Oftalmología , Facoemulsificación , Herida Quirúrgica , Humanos , Estudios Retrospectivos , Registros Electrónicos de Salud , Teorema de Bayes , Catarata/epidemiología , Complicaciones Posoperatorias , Medición de RiesgoRESUMEN
BACKGROUND: This randomized controlled trial evaluated the safety and effectiveness of weekly and biweekly applications of dehydrated human amnion and chorion allograft (dHACA) plus standard of care compared to standard of care alone on chronic venous leg ulcers. METHODS: This open-label randomized controlled trial included patients with chronic venous leg ulcers at eight wound care centers across the United States. The primary endpoint was the proportion of healed ulcers at 12 weeks. Secondary endpoints included the proportion of ulcers achieving 40 percent closure at 4 weeks and the incidence of adverse events. RESULTS: Among 101 patients screened for eligibility, 60 were eligible and enrolled. At 12 weeks, significantly more venous leg ulcers healed in the two dHACA-treated groups (75 percent) than in the standard-of-care group (30 percent) ( p = 0.001) even after adjustment for wound area ( p = 0.002), with an odds ratio of 8.7 (95 percent CI, 2.2 to 33.6). There were no significant differences in the proportion of wounds with percentage area reduction greater than or equal to 40 percent at 4 weeks among all groups. The adverse event rate was 63.5 percent. Among the 38 adverse events, none were graft or procedure related, and all were resolved with appropriate treatment. CONCLUSIONS: dHACA and standard of care, either applied weekly or biweekly, significantly healed more venous leg ulcers than standard of care alone, suggesting that the use of aseptically processed dHACA is advantageous and a safe and effective treatment option in the healing of chronic venous leg ulcers. CLINICAL QUESTION/LEVEL OF EVIDENCE: Therapeutic, I.
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Úlcera de la Pierna , Úlcera Varicosa , Humanos , Amnios , Úlcera , Úlcera Varicosa/cirugía , Corion/trasplante , Cicatrización de HeridasRESUMEN
Purpose: Both acne keloidalis nuchae (AKN) and cutis verticis gyrata (CVG) are scalp conditions predominantly affecting men. Both are characterized by dermal thickening and fibroblast hyperactivity. AKN typically occurs in the nuchal area, often involving the naturally occurring folds in the occipital region. The aim of this study was to determine the relationship between excessive scalp folding (CVG) and AKN. Patients and methods: A total of 108 patients with AKN seen over 11 years from July 2009 and November 2020 were retrospectively evaluated. Patients with AKN concomitant with CVG were selected for analysis. Results: Seven of the 108 AKN patients had scalp-wide (widespread) AKN lesions, including 4 with CVG. In 3 of the 4 patients with concomitant AKN and CVG, the AKN was widespread, and its onset had preceded CVG by 1-2 years. In the fourth CVG patient, AKN lesions were confined to the nuchal area, and the CVG preceded AKN onset by several years. All patients were male, with a mean age of 35.8 years (overall) and 38.0 years (CVG group). Conclusion: We describe a previously unreported relationship between widespread AKN and CVG, with the development of AKN preceding CVG formation.
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Introduction: The difficulty of the follicular unit excision (FUE) hair transplantation procedure is currently attributed to hair curliness and subsurface angulation. Patients possessing the curliest hair shafts are considered the most challenging. Consequently, patients with these features are often denied FUE. However, this practice does not consider intrapatient variation in the graft attrition rate and the rates themselves, which are frequently low in very curly hair where the skin firmness/thickness is average. To better aid practitioners in predicting FUE performance, we have developed a new scoring system (the Sanusi FUE Score Scale [SFS Scale]) based on two major donor variables (hair and skin characteristics). Material and Method: The scale assigns scores to each of three hair subtypes (straight-wavy, curly, and coily-kinky) and each of three skin subtypes (thick/firm, soft/thin, and medium thickness/firmness). The scores were weighted based on the assessment of 13 experienced FUE practitioners from around the globe, who were asked to score each of the three skin and hair characteristics for their contribution to FUE difficulty. Results: On the contribution of skin characteristics to FUE difficulty, 12/13 (92%) practitioners assigned the highest (most difficult) score to thick/firm skin, with medium skin thickness/firmness being the least challenging. The same percentage of practitioners gave the highest difficulty score to coiled-kinky hair subtypes regarding the contribution of hair characteristics to FUE difficulty. All agreed that straight-wavy hair presents the least challenge to FUE performance. Tallying the scores of the skin and hair variables generates a final score range of 2-9, which is associated with five grades/classes of challenge in the FUE procedure, influencing the need for a specialized skill/nuanced approach or equipment. Conclusion: We developed a universal FUE donor scoring scale that accounts for the diversity of human hair and skin types. Further evaluation to determine the validity of this new classification system in predicting and grading FUE difficulty and patient outcomes is warranted.
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INTRODUCTION: Lichen planopilaris (LPP) is characterized by chronic scarring alopecia that is progressive and typically refractory to therapy. Current drug treatments are suboptimal and not applicable for long-term use because of the high potential for adverse effects, warranting safer and more effective treatment alternatives. METHODS: Based on our previous success in treating a patient with central centrifugal cicatricial alopecia using a topical botanical formulation (Gashee), we reviewed records of four patients with biopsy-proven LPP treated with the topical formulation alone or in combination with its oral preparation. Three patients had failed previous treatment with intralesional steroid injections, topical minoxidil, tacrolimus, and clobetasol. Physical examination and photographic documentation were also used as outcome measures. Treatment duration with the botanical formulations ranged from 6 weeks to 9.5 months. RESULTS: All patients showed overall improvement in surrogate indicators of LPP activity as evidenced by the disappearance of symptoms (pruritus, tenderness, scalp irritation, and hair shedding), improvement in hair growth, and reduction in redness. All reported a high satisfaction level and no adverse effects. CONCLUSIONS: Patients with treatment-refractory LPP responded to a novel botanical treatment. To the best of our knowledge, this is the first published report of LPP responding to a plant-based natural treatment. Further evaluation of this treatment in a controlled trial with a larger number of patients is warranted.
Lichen planopilaris is a chronic and progressive condition, most commonly affecting middle-aged women. It results in scalp inflammation, scarring, and ultimately permanent hair loss. Treatments are typically ineffective in the long term and are associated with side effects that limit their use. We report success in treating four patients using a new botanical formulation called Dr. UGro Gashee as the sole therapy for a duration ranging from 6 weeks to 9.5 months. The treatment was administered topically or in combination with its oral formulation. All the patients showed cessation of disease progression with significant hair regrowth. They also reported complete resolution of scalp itch, tenderness, and irritation, with no adverse effects. Our report is the first published study of lichen planopilaris responding to a plant-based natural treatment and warrants further evaluation in larger controlled trials.
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PURPOSE: To develop a simple but more precise model to calculate potential annual productivity losses due to blindness and moderate and severe vision impairment (MSVI) at the national, regional, and global level. METHODS: Productivity loss was defined as the loss of minimum wage/Gross National Income per capita (GNI) incurred by people aged 50-64 years with blindness or MSVI, who were not able to work or worked with reduced earnings in 2020. We developed a global list of minimum wage data from on-line sources. All other model data were sourced from international, standardised, and open-access databases. For blindness, the total productivity loss (not working) incurred by 64%-90% of the affected population was summed up with partial productivity loss, defined as 10%-36% of the affected population earning one-third of that of the sighted population. For MSVI, the total productivity loss for 30%-55% of the affected population was summed with the partial productivity loss, defined as 45%-70% of the affected population having 35% reduced earnings. The costs of blindness and MSVI were summed to obtain the cost of combined vision loss. RESULTS: The global cost of vision loss based on minimum wage was US$160-US$216.32 billion for 2020. The global cost of vision loss using GNI was US$449.36-US$584.66 billion. CONCLUSIONS: A parsimonious model that considers minimum wage and GNI potentially lost due to blindness and MSVI can be used for eye care programming planning and advocacy at the national, regional, and global level.
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Purpose: Central centrifugal cicatricial alopecia (CCCA) is the most common cause of scarring alopecia in women of African descent. However, current treatments for CCCA, such as immunosuppressants and immunomodulatory pharmaceutical agents, have suboptimal efficacy and undesirable side effects. This case series reports the therapeutic effect of a new botanical formulation (Dr. UGro Gashee) in four patients with histologically supported diagnoses of CCCA. The formulations contain at least three phytoactive ingredients that affect multiple targets in the cascade of pathophysiologic events contributing to CCCA. Possible mechanisms of action include anti-inflammatory effects, inhibiting proinflammatory cytokines, and the net antifibrotic effect of inhibiting transforming growth factor-beta while upregulating AMP-activated protein kinase and peroxisome proliferator-associated receptor-gamma activity. Patients and Methods: Four African American women with treatment-refractory CCCA were treated with a new topical botanical formula (cosmeceutical) alone or in combination with its oral formulation (nutraceutical) for 8 weeks to 1 year. The cosmeceutical and nutraceutical treatments contain similar phytoactive ingredient profiles. Treatment outcomes were collected using documented patient reports and images and by direct observation. Results: In all patients, scalp pruritus cessation occurred within 2 weeks of treatment, and significant hair regrowth was observed within 2 months. All patients reported a high satisfaction level without adverse effects. Conclusion: Patients with treatment-refractory CCCA responded to the novel botanical treatment reported in this study. Further evaluations in a controlled trial with more patients are warranted.
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Amniotic membranes are known to be rich in growth factors, cytokines, and matrix proteins, which can help support wound closure and may improve patient outcomes in foot and ankle surgical interventions. In this Institutional Review Board (IRB) approved clinical study, 21 consecutive patients undergoing lower extremity soft tissue and bone reconstruction surgery received dehydrated human amnion and chorion allograft (dHACA) placed as a covering over the deep layers of the surgical wound during closure. Wound healing complications were assessed and American Orthopaedic Foot and Ankle Society (AOFAS) scores were compiled from over a 1-year follow-up period. Summary statistics were calculated for average pain, function, and alignment. The average overall AOFAS pre-treatment score was 35.8 ± 23.0 and the post-treatment score significantly improved to 87.5 ± 6.4 (P = 3.7 × 10-10 ). The pain-score improved from pre-treatment at 10.0 ± 11.0 to post-treatment at 36.7 ± 4.8 (P = 5.0 × 10-5 ). The pre-treatment function score was 18.7 ± 12.9 and at post-treatment increased to 38.5 ± 5.7 (P = 5.8 × 10-5 ). Lastly, the alignment score at pre-treatment was 7.1 ± 4.4 and at post-treatment was 12.4 ± 2.6 (P = .001). These improvements in functional scores were accompanied with clinical observations of reduced surgical complications including a lack of wound dehisance in the cohort. These clinical findings suggest that the application of aseptically processed dHACA may reduce wound complications and as such may aide in clinical improvements in foot and ankle surgical interventions however a larger comparative trial should be considered to validate these initial findings.