Dehydrated human amnion/chorion membrane to treat venous leg ulcers: a cost-effectiveness analysis.

OBJECTIVE: To evaluate the cost-effectiveness of dehydrated human amnion/chorion membrane (DHACM) in Medicare enrolees who developed a venous leg ulcer (VLU). METHOD: This economic evaluation used a four-state Markov model to simulate the disease progression of VLUs for patients receiving advanced treatment (AT) with DHACM or no advanced treatment (NAT) over a three-year time horizon from a US Medicare perspective. DHACM treatments were assessed when following parameters for use (FPFU), whereby applications were initiated 30-45 days after the initial VLU diagnosis claim, and reapplications occurred on a weekly to biweekly basis until completion of the treatment episode. The cohort was modelled on the claims of 530,220 Medicare enrolees who developed a VLU between 2015-2019. Direct medical costs, quality-adjusted life years (QALYs), and the net monetary benefit (NMB) at a willingness-to-pay threshold of $100,000/QALY were applied. Univariate and probabilistic sensitivity analyses (PSA) were performed to test the uncertainty of model results. RESULTS: DHACM applied FPFU dominated NAT, yielding a lower per-patient cost of $170 and an increase of 0.010 QALYs over three years. The resulting NMB was $1178 per patient in favour of DHACM FPFU over the same time horizon. The rate of VLU recurrence had a notable impact on model uncertainty. In the PSA, DHACM FPFU was cost-effective in 63.01% of simulations at the $100,000/QALY threshold. CONCLUSION: In this analysis, DHACM FPFU was the dominant strategy compared to NAT, as it was cost-saving and generated a greater number of QALYs over three years from the US Medicare perspective. A companion VLU Medicare outcomes analysis revealed that patients who received AT with a cellular, acellular and matrix-like product (CAMP) compared to patients who received NAT had the best outcomes. Given the added clinical benefits to patients at lower cost, providers should recommend DHACM FPFU to patients with VLU who qualify. Decision-makers for public insurers (e.g., Medicare and Medicaid) and commercial payers should establish preferential formulary placement for reimbursement of DHACM to reduce budget impact and improve the long-term health of their patient populations dealing with these chronic wounds. DECLARATION OF INTEREST: Support for this analysis was provided by MiMedx Group, Inc., US. JLD, and RAF are employees of MiMedx Group, Inc. WHT, BH, PS, BGC and WVP were consultants to MiMedx Group, Inc. VD, AO, MRK, JAN, NW and GAM served on the MiMedx Group, Inc. Advisory Board. MRK and JAN served on a speaker's bureau. WVP declares personal fees and equity holdings from Stage Analytics, US.

Treatment patterns and outcomes of Medicare enrolees who developed venous leg ulcers.

OBJECTIVE: To retrospectively evaluate the comorbidities, treatment patterns and outcomes of Medicare enrolees who developed venous leg ulcers (VLUs). METHOD: Medicare Limited Data Standard Analytic Hospital Inpatient and Outpatient Department Files were used to follow patients who received medical care for a VLU between 1 October 2015 and 2 October 2019. Patients diagnosed with chronic venous insufficiency (CVI) and a VLU were propensity matched into four groups based on their treatment regimen. Episode claims were used to document demographics, comorbidities and treatments of Medicare enrolees who developed VLUs, as well as important outcomes, such as time to ulcer closure, rates of complications and hospital utilisation rates. Outcomes were compared across key propensity-matched groups. RESULTS: In total, 42% of Medicare enrolees with CVI (n=1,225,278), developed at least one VLU during the study, and 79% had their episode claim completed within one year. However, 59% of patients developed another VLU during the study period. This analysis shows that only 38.4% of VLU episodes received documented VLU conservative care treatment. Propensity-matched episodes that received an advanced treatment or high-cost skin substitutes for a wound which had not progressed by 30 days demonstrated the best outcomes when their cellular, acellular, matrix-like product (CAMP) treatment was applied weekly or biweekly (following parameters for use). Complications such as rates of infection (33%) and emergency department visits (>50%) decreased among patients who received an advanced treatment (following parameters for use). CONCLUSION: Medicare enrolees with CVI have diverse comorbidities and many do not receive sufficient management, which contributes to high rates of VLUs and subsequent complications. Medicare patients at risk of a VLU who receive early identification and advanced CAMP treatment demonstrated improved quality of life and significantly reduced healthcare resource utilisation.

Cost-per-Response Analysis of Pure Hypochlorous Acid Among Patients with Chronic Venous Leg Ulcers: A Health Economic Analysis.

OBJECTIVE: To estimate the total cost-per-wound healing response (CPR) and the per-day CPR of patients with chronic leg ulcers treated with pure hypochlorous acid (pHA) as part of their overall would healing regimen. METHODS: The authors developed a deterministic decision-tree model to estimate the incremental CPR for pHA. The analysis was performed using clinical data from a published single-arm prospective study. The outcome of interest was re-epithelialization at 90 days. Economic data for pHA were based on public prices of pHA per dressing change from the wound care center perspective. The following time points were assessed: 90, 60, and 30 days. Dressing changes occurred every 2.5 days. Sensitivity analysis was performed to gauge the robustness of the results. RESULTS: A total of 31 patients (68% women) with 31 lesions (average age of wound, 29 months; range, 1-240 months) were included in the clinical study. Re-epithelialization occurred in 23 lesions (74%) at 90 days, 17 (55%) at 60 days, and 3 (10%) at 30 days. The total CPRs were $75.69, $68.27, and $193.44, and the per-day CPRs were $0.84, $1.13, and $6.45 at 90, 60, and 30 days, respectively. The sensitivity analysis revealed that CPRs ranged from $0.63 to $1.12 per day at 90 days. CONCLUSIONS: Incorporating pHA into standard wound healing protocols is a minimal added expense and may yield a substantial economic savings of $2,695 at 90 days.

Cost-effectiveness of dehydrated human amnion/chorion membrane allografts in lower extremity diabetic ulcer treatment.

OBJECTIVE: To evaluate the cost-effectiveness and budget impact of using standard care (no advanced treatment, NAT) compared with an advanced treatment (AT), dehydrated human amnion/chorion membrane (DHACM), when following parameters for use (FPFU) in treating lower extremity diabetic ulcers (LEDUs). METHOD: We analysed a retrospective cohort of Medicare patients (2015-2019) to generate four propensity-matched cohorts of LEDU episodes. Outcomes for DHACM and NAT, such as amputations, and healthcare utilisation were tracked from claims codes, analysed and used to build a hybrid economic model, combining a one-year decision tree and a four-year Markov model. The budget impact was evaluated in the difference in per member per month spending following completion of the decision tree. Likewise, the cost-effectiveness was analysed before and after the Markov model at a willingness to pay (WTP) threshold of $100,000 per quality adjusted life year (QALY). The analysis was conducted from the healthcare sector perspective. RESULTS: There were 10,900,127 patients with a diagnosis of diabetes, of whom 1,213,614 had an LEDU. Propensity-matched Group 1 was generated from the 19,910 episodes that received AT. Only 9.2% of episodes were FPFU and DHACM was identified as the most widely used AT product among Medicare episodes. Propensity-matched Group 4 was limited by the 590 episodes that used DHACM FPFU. Episodes treated with DHACM FPFU had statistically fewer amputations and healthcare utilisation. In year one, DHACM FPFU provided an additional 0.013 QALYs, while saving $3,670 per patient. At a WTP of $100,000 per QALY, the five-year net monetary benefit was $5003. CONCLUSION: The findings of this study showed that DHACM FPFU reduced costs and improved clinical benefits compared with NAT for LEDU Medicare patients. DHACM FPFU provided better clinical outcomes than NAT by reducing major amputations, ED visits, inpatient admissions and readmissions. These clinical gains were achieved at a lower cost, in years 1-5, and were likely to be cost-effective at any WTP threshold. Adoption of best practices identified in this retrospective analysis is expected to generate clinically significant decreases in amputations and hospital utilisation while saving money.

Observed impact of skin substitutes in lower extremity diabetic ulcers: lessons from the Medicare Database (2015-2018).

OBJECTIVE: To evaluate large propensity-matched cohorts to assess outcomes in patients receiving advanced treatment (AT) with skin substitutes for lower extremity diabetic ulcers (LEDUs) versus no AT (NAT) for the management of LEDUs. METHOD: The Medicare Limited Dataset (1 October 2015 through 2 October 2018) were used to retrospectively analyse people receiving care for a LEDU treated with AT or NAT (propensity-matched Group 1). Analysis included major and minor amputations, emergency department (ED) visits and hospital readmissions. In addition, AT following parameters for use (FPFU) was compared with AT not FPFU (propensity-matched Group 2). A paired t-test was used for comparisons of the two groups. For comparisons of three groups, the Kruskal-Wallis test was used. A Bonferroni correction was performed when multiple comparisons were calculated. RESULTS: There were 9,738,760 patients with a diagnosis of diabetes, of whom 909,813 had a LEDU. In propensity-matched Group 1 (12,676 episodes per cohort), AT patients had statistically fewer minor amputations (p=0.0367), major amputations (p<0.0001), ED visits (p<0.0001), and readmissions (p<0.0001) compared with NAT patients. In propensity-matched Group 2 (1131 episodes per cohort), AT FPFU patients had fewer minor amputations (p=0.002) than those in the AT not FPFU group. CONCLUSION: AT for the management of LEDUs was associated with significant reductions in major and minor amputation, ED use, and hospital readmission compared with LEDUs managed with NAT. Clinics should implement AT in accordance with the highlighted parameters for use to improve outcomes and reduce costs.

In Vitro Characterization of Pressure Redistribution Among Commercially Available Wound Dressings.

OBJECTIVE: Recent clinical evidence has suggested that certain wound dressings may play a significant role in protocols to prevent or reduce pressure injury (PI) in patients at risk by modifying the pressure, friction, and shear forces that can contribute to PI. The aim of this study was to investigate the pressure reduction properties of commercially available wound dressings in vitro. METHODS: Using a standardized protocol (1.7 kg, 7.5-cm sphere), testing was performed in a controlled environment by the same clinician using a pressure mapping device (XSENSOR LX205; XSENSOR Technology Corporation, Calgary, Alberta, Canada) to measure and compare the pressure mitigation properties in a variety of wound dressings. RESULTS: A total of 13 different commercially available dressings were tested in triplicate for changes in pressure redistribution as compared with the control. One dressing demonstrated the greatest reduction of pressure forces (OxyBand PR; 50.33 ± 1.45 mm Hg) compared with the control (302.7 ± 0.33 mm Hg) and the greatest surface area of all the study dressings tested. There was a negative correlation (R2 = 0.73) between the average pressure distribution of a wound dressing and its contact area. Further, the peak pressure for OxyBand PR (P ≤ .05) was significantly different from all other tested dressings. CONCLUSIONS: One dressing (OxyBand PR) provided superior pressure redistribution and significantly reduced peak pressure in this study when compared with currently available standard foam and silicone dressings that are marketed for the purpose of PI prevention.

Outcomes of Radiation Injuries Using Hyperbaric Oxygen Therapy: An Observational Cohort Study.

BACKGROUND: The late effects of radiation therapy following the treatment of cancer are a well-known consequence. Evidence increasingly supports the use of hyperbaric oxygen (HBO) as an adjunctive treatment in a variety of radiation injuries. OBJECTIVE: To present the findings of a new registry of radiation injuries that was developed to evaluate the outcomes and treatment parameters of HBO treatment (HBOT) when applied to patients experiencing the late effects of radiation therapy. DESIGN: Observational cohort. SETTING: Hyperbaric oxygen clinical treatment facilities in the United States. PATIENTS: A total of 2538 patients with radiation-induced injuries. MEASUREMENTS: Injury type, patient age, gender, diabetes, end-stage renal disease, collagen vascular disease, coronary artery disease/peripheral vascular disease, on anticoagulant medication, on systemic steroid medication, patient is current smoker, patient abuses alcohol, symptoms reported, duration of symptoms, symptom progression prior to HBOT, transfusion units, HBOT time, HBOT count, HBO chamber pressure, HBO time in chamber, and patient outcomes. RESULTS: A total of 2538 patient entries with 10 types of radiation injuries were analyzed. The 5 most common injuries were osteoradionecrosis (33.4%), dermal soft tissue radionecrosis (27.5%), radiation cystitis (18.6%), radiation proctitis (9.2%), and laryngeal radionecrosis (4.8%). Clinical outcomes following HBOT were positive with symptoms that improved or resolved varying from 76.7% to 92.6%, depending on injury type. Overall, although the mean symptom improvement score between some groups is statistically significant, the differences are probably not clinically meaningful. Patients with osteoradionecrosis had the highest mean symptom improvement score (3.24) compared with a mean of 3.04 for laryngeal radionecrosis. LIMITATIONS: Limited data were available on patient comorbidities and symptom severity. CONCLUSIONS: Outcomes from a large patient registry of radiation-induced injuries support the continued therapeutic use of HBOT for radiation injuries.

The American College of Hyperbaric Medicine consensus statement on physician credentialing for hyperbaric oxygen therapy.

The American College of Hyperbaric Medicine provides this document for hospital credentialing committees as national standards for credentialing hyperbaric physicians. These recommendations represent the consensus opinion of expert leaders in the field of hyperbaric medicine. The principles set forth in this document are intended to serve as a guideline to assist healthcare organizations. This document applies to both hospital-based and nonhospital-affiliated centers.

The management of intractable pain with adjuvant pulsed electromagnetic field therapy.

This case describes a 51-year-old woman who reported experiencing severe, constant pain, diffusely located in the region of her right mandible neck (primarily involving the mandible, lower right molars, the neck, the upper back, and the shoulder) during the course of several years. Surgical interventions (root canal, spinal fusion) were performed to address potential sources of pain. Despite these interventions, the patient reported severe pain after both surgeries, which persisted beyond the acute postoperative period. Additional pharmacological interventions and physical therapy were also attempted; nonetheless, the patient reported that pain remained severe and constant for approximately 2 years. On the basis of the patient's poor response to conventional treatments, a novel approach of botulinum toxin (BTX) injections was initiated. When pulsed electromagnetic field therapy was added, the need for BTX injections decreased, with the patient reporting a noticeable decrease in pain intensity and an improvement in quality of life measures. Currently, the patient continues to use pulsed electromagnetic field therapy regularly for pain management, which has allowed her to reduce the use of other interventions and avoid continued use of narcotic medications. Considering the need for multifaceted pain management approaches in the treatment of chronic pain, this case is relevant for wound care practitioners attending to patients with chronic postincisional wound pain because the outcome highlights the utility of a nonpharmacological, complementary pain management intervention for closed, yet persistently painful, postoperative wounds.

Evaluation of Vashe Wound Therapy in the clinical management of patients with chronic wounds.

OBJECTIVE: To analyze if Vashe Wound Therapy (PuriCore, Malvern, Pennsylvania) is a valuable contribution to standard protocols of wound care. DESIGN: Open, noncomparative study. SETTING: Outpatient clinic. PATIENTS: Thirty-one patients, primarily with venous or mixed venous/arterial leg ulcers. INTERVENTIONS: Vashe Wound Therapy (hypochlorous acid, produced on site and on demand) was used as an adjunct to a standard wound care protocol. MAIN OUTCOME MEASURES: Wound healing, reduction of pain, and odor. MAIN RESULTS: At the end of the study, 86% of all lesions healed, and the average size of reduction in nonhealed wounds was 47%. Odor was present at the beginning of enrollment in 21 patients and was rated 4.58 on the visual analog scale. In all patients, the odor score at end of treatment was zero. Seventy-seven percent of all patients reported a positive pain score at the beginning of participation in the evaluation (average pain score, 4.7). At the end of the study, no patient experienced pain. CONCLUSION: Vashe Wound Therapy is a valuable contribution to standard protocols of wound care.

Impaired lower extremity wound healing secondary to sirolimus after kidney transplantation.

PURPOSE: Sirolimus is an immunosuppressive drug used as part of the drug regimen after kidney, liver, and heart transplantation. There have been numerous reports of transplant surgical wound healing complications secondary to sirolimus. The authors present a case of impaired wound healing in the lower extremity after kidney transplantation for a patient on sirolimus. This is one of the few reported cases that we are aware of that demonstrates the effects of sirolimus on wound healing at a nontransplant site. METHODS: A case highlighting aggressive limb-salvage modalities for a kidney transplant patient on sirolimus is presented. The subject was informed that data concerning the case would be submitted for publication. A brief review of the literature shows the wound healing problems previously associated with sirolimus. RESULTS: Despite all salvage techniques employed, including aggressive early debridement, forefoot offloading, IV antibiotics, negative pressure wound therapy, and hyperbaric oxygen therapy, the patient eventually went on to failure and a transtibial amputation. CONCLUSION: Physicians specializing in wound care and limb salvage must be aware of the effects of sirolimus on wound healing and should consider modifications to these patients' immunosuppressive regimens.

A comparison of diabetic foot ulcer outcomes using negative pressure wound therapy versus historical standard of care.

Diabetic foot ulcers (DFUs) are a leading cause of morbidity and hospitalisation among patients with diabetes. We analysed claims data for Medicare part B diabetic foot ulcer patients treated with Negative Pressure Wound Therapy at home (N = 1135) and diabetic foot ulcer patients from a published meta-analysis of randomised controlled wet-to-moist therapy. The expected costs of care for the two treatments were also compared. A significantly greater proportion of wounds treated with NPWT achieved a successful treatment endpoint compared with wet-to-moist therapy at both 12 weeks (39.5% versus 23.9%; P < 0.001) and 20 weeks (46.3% versus 32.8%; P < 0.001). NPWT-treated patients reached a successful wound treatment endpoint more rapidly, and the benefit was apparent in all wound sizes. Expected 20-week treatment costs for NPWT were similar to those for wet-to-moist therapy if one nursing visit per day for the latter is assumed but 42% less if two nursing visits per day are made. Thus, NPWT may improve the proportion of DFUs that attain a successful wound treatment endpoint and decrease resource utilisation by a given health care system compared with standard wet-to-moist therapy.

Consensus statement on negative pressure wound therapy (V.A.C. Therapy) for the management of diabetic foot wounds.

UNLABELLED: In 2004, a multidisciplinary expert panel convened at the Tucson Expert Consensus Conference (TECC) to determine appropriate use of negative pressure wound therapy as delivered by a Vacuum Assisted Closure device (V.A.C. THERAPY, KCI, San Antonio, Texas) in the treatment of diabetic foot wounds. These guidelines were updated by a second multidisciplinary expert panel at a consensus conference on the use of V.A.C. THERAPY, held in February 2006, in Miami, Florida. This updated version of the guidelines summarizes current clinical evidence, provides practical guidance, offers best practices to clinicians treating diabetic foot wounds, and helps direct future research. The Miami consensus panel discussed the following 12 key questions regarding V.A.C. THERAPY: (1) How long should V.A.C. THERAPY be used in the treatment of a diabetic foot wound? (2) Should V.A.C." THERAPY be applied without debriding the wound? (3) How should the patient using V.A.C. THERAPY be evaluated on an outpatient basis? (4) When should V.A.C. THERAPY be applied following revascularization? (5) When should V.A.C. THERAPY be applied after incision, drainage, and debridement of infection? (6) Should V.A.C. THERAPY be applied over an active soft tissue infection? (7) How should V.A.C. THERAPY be used in patients with osteomyelitis? (8) How should noncompliance to V.A.C. THERAPY be defined? (9) How should V.A.C. THERAPY be used in combination with other modalities? (10) Should small, superficial wounds be considered for V.A.C. THERAPY? (11) How should success in the use of V.A.C. THERAPY be defined? (12) How can one combine effective offloading and V.A.C. THERAPY?

Hyperoxic and hyperbaric-induced cardioprotection: role of nitric oxide synthase 3.

OBJECTIVE: The relative contributions of the fraction of inspired oxygen (FIO2) and atmospheric pressure (ATM) to cardioprotection are unknown. We determined whether the product of FIO2 x ATM (oxygen partial pressure) controls the extent of hyperoxic+hyperbaric-induced cardioprotection and involves activation of nitric oxide synthase (NOS). METHODS: Adult Sprague Dawley rats (n = 10/gp) were treated for 1 h with (1) normoxia+normobaria (21% O2 at 1 ATM), (2) hyperoxia+normobaria (100% O2 at 1 ATM), (3) normoxia+hyperbaria (21% O2 at 2 ATM) and (4) hyperoxia+hyperbaria (100% O2 at 2 ATM). RESULTS: Infarct size following 25 min ischemia and 180 min reperfusion was decreased following hyperoxia+normobaria and normoxia+hyperbaria compared with normoxia+normobaria and further decreased following hyperoxia+hyperbaria treatment. l-NAME (200 microM) reversed the cardioprotective effects of hyperoxia+hyperbaria. Nitrite plus nitrate content was increased 2.2-fold in rats treated with normoxia+hyperbaria and hyperoxia+hyperbaria. NOS3 protein increased 1.2-fold and association of hsp90 with NOS3 four-fold in hyperoxic+hyperbaric rats. CONCLUSIONS: Cardioprotection conferred by hyperoxia+hyperbaria is directly dependent on oxygen availability and mediated by NOS.

The effective management of pressure ulcers.

The challenges of managing pressure ulcers are often not limited to clinical decisions; they may impact other areas that encompass patient care, including financial, emotional, psychosocial, regulatory, and medical-legal aspects. The difficulty in managing these complex factors is magnified by recent gains in understanding of the pathophysiology of wounds related to pressure, which serves as the basis for the etiology, diagnosis, staging, and management of these wounds. This article summarizes the current and evolving knowledge related to pressure ulcers and discusses an algorithm recently developed to assist in clinical management decisions related to patients with pressure ulcers, with emphasis on appropriate utilization of Negative Pressure Wound Therapy delivered by V.A.C. Therapy (KCI USA, Inc.) in patients with Stage III and Stage IV pressure ulcers.