Best-practice algorithms for the use of a bilayered living cell therapy (Apligraf®) in the treatment of lower-extremity ulcers

Tissue-engineered skin substitutes such as Apligraf have emerged over the past 20 years as among the most carefully studied and efficacious of the advanced wound modalities. These products have been proven as effective enhancements to general wound care, promoting wound closure particularly in instances where conventional wound care fails. Marketed for hard-to-heal wounds since 1998, Apligraf has become part of standard wound care in many wound centers across the United States. Despite this situation, few general wound care guidelines incorporate advanced and active wound-healing technologies, such as tissue-engineered skin products. Because of this deficiency, appropriate patient selection and proper use of these product remain largely unaddressed within the general wound care community. Here, we describe the development of guidelines surrounding optimal use of the bilayered living cell therapy, Apligraf, in the treatment of the two types of lower extremity ulcers for which the product is FDA approved: venous leg ulcer and diabetic foot ulcer. The guidelines detailed in this article focus on the identification and selection of patients who are at risk for failure of standard wound care therapy and thus appropriate for Apligraf treatment. The intended audience for these guidelines is the general wound care practitioner, for whom the developed treatment algorithms and accompanying figure legends should provide practical, user-friendly direction simplifying both patient selection and appropriate use of Apligraf within the context of good wound-healing practice.     

Does the false-negative rate for 1 or 2 negative sentinel nodes after neo-adjuvant chemotherapy translate into a high local recurrence rate?

Prospective trials demonstrate that sentinel node (SN) biopsy after neo-adjuvant chemotherapy (NACT) has a significant false-negative rate (FNR) when only 1 or 2 SNs are removed. It is unknown whether this increased FNR correlates with an elevated risk of recurrence. Tumor Registry data at an NCI-Designated Comprehensive Cancer Center were reviewed from 2004 to 2018 for patients having a negative SN biopsy after NACT. Among 190 patients with histologically negative nodes after NACT having 1 (n = 42), 2 (n = 46), and ≥3 (n = 102) SNs, axillary recurrences occurred in 7.14%, 0%, and 1.96% (p = 0.09), breast recurrences occurred in 2.38%, 6.52%, and 0.98% (p = 0.12), and distance recurrences occurred in 16.67%, 8.70%, and 7.84% (p = 0.27), respectively. Time to first recurrence did not differ by SN count (p = 0.41). After adjustment for age, race, clinical stage, and receptor status, there were no differences in the rates of axillary (p = 0.26), breast (p = 0.44), or distance recurrence (p = 0.24) by numbers of SNs harvested. Median follow-up was 46.8 months. Despite higher post-NACT FNRs reported in randomized trials for patients having <3 sentinel nodes, recurrence rates were not significantly different for 1 versus 2 versus ≥3 SNs. This suggests that patients having 1 or 2 post-NACT SNs identified may not necessitate axillary dissection.     

MRI algorithm for medical necessity for auto accident injured patients

Rationale Magnetic resonance imaging (MRI) is often used as a diagnostic test to evaluate personal injury. However, it increases the health care cost. Therefore, it is important to study the necessity for using MRI. Objective To examine the percentages of MRI ordering between orthopaedic surgeon and non‐surgeon referring health care providers, and to propose an MRI an algorithm to reduce unnecessary MRI for patients with personal injuries. Methods This is a retrospective study. A total of 2000 patients that received a soft tissue injury and did not require surgery between 1 January 2000 and 31 December 2004, were examined. Among them, 1000 patients came directly to one of the authors, an orthopaedic surgeon, and other 1000 were referred to the same surgeon. The percentages of MRI ordered by the author and the referring health care providers are examined. For referred patients, the orthopaedic author re‐examined each patient to determine whether he thought the MRI was necessary. The Chi‐square test and McNemar's test are used for comparisons for the percentages, and confidence intervals are reported. The study examines the overall MRI ordering, and MRI ordering separately for body regions. Conclusions We found that there was a great disparity between the percentages of MRI ordering between the orthopaedic surgeon and the non‐surgeon referring doctors, the orthopaedic surgeon ordered significantly less MRI (P‐values < 0.001). Adopting the proposed algorithm of medical necessity for ordering MRI or considering early referral to an orthopaedic surgeon prior to ordering MRI can significantly reduce the medical cost for these patients.     

Clinical interventions for venous leg ulcers: Proposals to improve the quality of clinical leg ulcer research

The present status of clinical leg ulcer healing research was reviewed by 25 experts over 2 days on September 28 and 29, 2015. Multiple clinical effectiveness reviews were presented suggesting that published clinical wound healing research often does not meet present (2015) evidence based standards. Specific areas requiring remediation were highlighted and approaches to overcoming existing challenges were proposed. Participants using anonymous voting technology developed an action plan to resolve perceived deficiencies. Statements were accepted if 75% of participants agreed. Older patients with a high frequency of comorbid conditions posed particular difficulties in designing clinical research protocols and better diagnostic categorization is necessary A standardized model template for collecting information about diagnosis and evaluation of the effect of interventions on healing of all types of leg ulcers was considered a high priority. Such a model template could be modified depending on the specific etiology of the leg ulcers. Generally agreed on quantifiable standards to establish degree of morbidity was considered a high priority. There was universal agreement that sources of funding and conflicts of interest needed to be disclosed in presentations and all publications. All clinical research studies should be registered with appropriate authorities. There was substantial enthusiasm for a clinical research network with quality standards for membership and an advisory research core available to investigators. Such a network should be funded and actively managed to insure long‐term viability. The governance of such an entity needs to be established by the wound care community. The present trend to integrate patients into the clinical research process was endorsed and there was enthusiasm to develop patient advocacy for wound healing research.     

Diabetic foot ulcers: A framework for prevention and care

Complications secondary to diabetes, such as diabetic foot ulcers, continue to be a major worldwide health problem. At the same time, health care systems are changing rapidly, causing concern about the quality of patient care. While the ultimate effect of current changes on health care professionals and patient outcomes remain uncertain, measures commonly used to reduce costs, e.g., disease and multi discliplinary management strategies, have been shown to help prevent the occurrence of diabetic ulcers. In addition, ultilizing a multi discliplinary approach, the principles of off-loading and optimal wound care, the vast majority of diabetic foot ulcers can be expected to heal within 12 weeks of treatment. Education of primary care providers and patients is paramount. (WOUND REP REG 1999;7:7–16)