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.

Consensus recommendations for optimizing the use of intact fish skin graft in the management of acute and chronic lower extremity wounds.

BACKGROUND: Since 2017, the clinical use of IFSG has increased substantially in the United States, with some use in Europe and Asia as well. However, scant consensus data have been published on such use. OBJECTIVE: The authors sought to develop consensus recommendations for the clinical use of IFSG in the management of acute and chronic LEWs. METHODS: A panel of 8 expert clinicians in the United States used a 2-cycle NFG process to develop consensus statements based on their own clinical practice and the literature. At their initial meeting in October 2021, panel members discussed the management of DFUs, VLUs, atypical LEWs, and traumatic LEWs in their practices. Consensus statements were drafted, voted on, and rated by relative importance. At the second meeting in October 2022, the panel discussed the initial survey results; a second survey was conducted, and panel members revised the recommendations and indicated the relative importance of each in the final report. A systematic literature review of English-language articles published from January 2016 through November 2022 was conducted as well, using the search terms: "fish skin," "piscine graft," "fish tissue," "intact fish skin graft," "Cod skin," "Omega 3 fatty acid graft." RESULTS: Forty-three statements were generated and grouped into 5 sections comprising general recommendations for LEWs and recommendations specific to DFUs, VLUs, atypical LEWs, and traumatic LEWs. The primary general recommendation is the need to determine wound etiology based on clinical evaluation and reviewing related test results. For DFUs and VLUs, the main recommendations are to adhere to first-line therapy (ie, standard of care, follow conventional guidelines [multilayer compression therapy], offloading, and assessment of wound perfusion) before introducing IFSG. CONCLUSIONS: Publications on and clinical experience in the use of IFSGs have increased substantially in the past several years. The 43 consensus recommendations are meant to guide physicians in the optimal use of IFSG in the management of acute and chronic LEWs.

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.

Proceedings of the Leaders in Wound Healing conference.

SerenaGroup Research Foundation, New Orleans, 17-19 April 2023.

Innovative treatment utilizing an autologous blood clot for diabetic foot ulcers.

INTRODUCTION: Diabetic foot ulcer is a complex wound that requires considerable effort to restart a stalled healing process. In this study, a TABCT product was used in a point-of-care setting to treat DFUs by reconstructing the ECM and adjusting intricate phenotypes and mechanisms of mediators to progress towards complete healing. The mechanism of action consists of reconstruction of the ECM, which protects the wound area from further destruction while it incorporates into the ulcer to promote granulation over exposed vital structures (ie, tendons, bone, and neurovascular structures). OBJECTIVE: The authors evaluated the efficacy of the TABCT product in the management of DFUs. MATERIALS AND METHODS: Study participants were wound care patients in hospitals and clinics across the United States and Israel as part of a registry study (ClinicalTrials.gov: NCT04699305). Twenty-nine patients age 18 years or older with chronic DFUs were included. A blood clot was created using the patient's own peripheral blood in a point-of-care setting. An 18-mL blood sample was drawn from the patient and incorporated with calcium gluconate and kaolin to form a clot. Efficacy and superiority levels in PAR at week 4 and week 12 over the SOC treatment were established using the Agresti-Coull confidence interval. RESULTS: Treatment of DFUs using the TABCT product resulted in 22 patients (75.86%) achieving 50% PAR at week 4 and showed superiority when compared with SOC data in previously published studies. Complete closure was achieved in 28 wounds (95%) at week 12. CONCLUSION: In the current study, TABCT exhibited superiority over SOC treatment and provided granulation over vital structures with a reduction in overall wound size in a timely manner via incorporation and stimulation of the body's own healing capabilities.

Topical oxygen therapy in the treatment of diabetic foot ulcers: a multicentre, open, randomised controlled clinical trial.

OBJECTIVES: Perfusion and blood oxygen levels are frequently insufficient in patients with hard-to-heal wounds due to poor circulation, vascular disruption and vasoconstriction, reducing the wound's capacity to heal. This study aimed to investigate the effect of topical oxygen on healing rates in patients with hard-to-heal diabetic foot ulcers (DFUs) (i.e., non-responsive over four weeks). METHOD: This multicentre, open-label, community-based randomised clinical trial compared standard care (SOC) with or without continuous topical oxygen therapy (TOT) for 12 weeks in patients with DFUs or minor amputation wounds. SOC included debridement, offloading with total contact casting (TCC) and appropriate moisture balance. Primary endpoints were the number of patients to achieve complete wound closure and percentage change in ulcer size. Secondary endpoints were pain levels and adverse events. RESULTS: For the study, 145 patients were randomised with index ulcers graded Infectious Diseases Society of America (IDSA) 1 or 2, or Wagner 1 or 2. In the intention-to-treat analysis, 18/64 (28.1%) patients healed in the SOC group at 12 weeks compared with 36/81 (44.4%) in the SOC plus TOT group (p=0.044). There was a statistically significant reduction in wound area between the groups: SOC group mean reduction: 40% (standard deviation (SD) 72.1); SOC plus TOT group mean reduction: 70% (SD 45.5); per protocol p=0.005). There were no significant differences in changes to pain levels or adverse events. CONCLUSION: This study suggests that the addition of TOT to SOC facilitates wound closure in patients with hard-to-heal DFUs.

The Use of a Pure Native Collagen Dressing for Wound Bed Preparation Prior to Use of a Living Bi-layered Skin Substitute.

Management of chronic wounds in the outpatient setting is quite challenging. The extensive co-morbid medical problems of the chronically ill patient along with the complexities of the wound bed and its biochemical environment has led to a plethora of patients with poor wound healing. This ever increasing population is a challenge for the wound care practitioner and cost to the health care system and patient. Increased wound chronicity has promulgated the use of advanced wound care products, including Living Skin Substitutes (LSS), in an attempt to obtain wound closure, and ultimately both physiological and functional healing.(1-3) In the outpatient setting, it is evident that the efficacy of the LSS varies widely depending on the patient type with some patients responding quite favorably while others who do not achieve healing despite repeated applications of LSS. This case series demonstrates that a systematic method of wound bed preparation prior to the application of LSS improved healing outcomes. The entire wound bed preparation protocol included autolytic, non-selective, and sharp-selective debridement, if deemed appropriate, followed by the weekly application of a pure native collagen. The wound bed preparation protocol was completed prior to LSS application. This case series presents evidence supporting the application of a 100% native collagen dressing to wound bed prior to the final step of LSS utilization.