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Objective: Massive (≥100 cm(2)) venous leg ulcers (VLUs) demonstrate very low closure rates with standard compression therapy and are costly to manage. Negative-pressure wound therapy (NPWT), followed by a split-thickness skin graft (STSG), can be a cost-effective alternative to this standard care. We performed a cost analysis of these two treatments., Methods: A retrospective review was performed of 10 ulcers treated with surgical debridement, 7 days of inpatient NPWT with topical antiseptic instillation (NPWTi), and STSG, with 4 additional days of inpatient NPWT bolster over the graft. Independent medical cost estimators were used to compare the cost of this treatment protocol with standard outpatient compression therapy., Results: The average length of time ulcers were present before patients entered the study was 38 months (range, 3-120 months). Eight of 10 patients had complete VLU closure by 6 months after NPWTi with STSG. The 6-month costs of the proposed treatment protocol and standard twice-weekly compression therapy were estimated to be $27,000 and $28,000, respectively., Conclusions: NPWTi with STSG treatment is more effective for closure of massive VLUs at 6 months than that reported for standard compression therapy. Further, the cost of the proposed treatment protocol is comparable with standard compression therapy., (Copyright © 2015 Society for Vascular Surgery. Published by Elsevier Inc. All rights reserved.)

Objective: To examine patient and wound variables presumed to influence healing outcomes in the context of therapeutic trials for chronic venous leg ulcers., Methods: This double-blind, vehicle-controlled study was conducted with randomized assignment to one of four cell therapy dose groups (n = 46, 43, 44, 45) or vehicle control (n = 50). A 2-week run-in period was used to exclude rapid healers and those with infection or uncontrolled edema. This was a multicenter (ambulatory, private, hospital-based and university-based practices, and wound care centers in North America) study. Adults ≥ 18 years old with chronic venous insufficiency associated with an uninfected venous leg ulcer (2-12 cm(2) area, 6-104 weeks' duration) were included in the study. Excluded were pregnant or lactating women, wounds with exposed muscle, tendon or bone, patients unable to tolerate compression bandages, or patients who had exclusionary medical conditions or exposure to certain products. Exclusion during run-in included patients with infection, uncontrolled severe edema or with healing rates ≥ 0.349 cm/2 wk. Screen fail rate was 37% (134/362), and the withdrawal rate was~10% (23 of 228). Growth-arrested neonatal dermal fibroblasts and keratinocytes were delivered via pump spray in a fibrin sealant-based matrix, plus a foam dressing and four-layer compression bandaging. Treatment continued for 12 weeks or until healed, whichever occurred first. Patient demographic and wound-related variables were evaluated for influence on complete wound healing in all patients, as well as the subsets of treated and control patients., Results: Wound duration (P = .004) and the presence of specific quantities of certain bacterial species (P < .001) affected healing in the vehicle group, while healing in the cell-treated groups was influenced by wound duration (P = .012), wound area (P = .026), wound location (P = .011), and specific quantities of certain bacterial species (P = .002). Age, sex, race, diabetes, HbA1C, peripheral neuropathy, and serum prealbumin did not significantly affect healing. Body mass index was positively associated with healing in cell-treated patients., Conclusions: Wound duration is a quantifiable surrogate for one or more undefined variables that can have a profound negative effect on venous leg ulcer healing. Although cell therapy overcame barriers to healing, the only specific barrier identified was the presence of certain bacterial species. Interventional trials of potentially effective new therapies can be most informative when patients with suspected barriers to healing are included. The specific measurement of candidate barriers such as microbial pathogens, wound inflammatory state, and fibroblast function should be considered in future randomized trials to improve our understanding of the basis for chronicity., (Copyright © 2013 Society for Vascular Surgery. Published by Mosby, Inc. All rights reserved.)

Objective: This study was undertaken to examine recent trends in the outcomes of patients with end-stage renal disease (ESRD) undergoing infrainguinal bypass grafting (IBG) with autogenous vein., Methods: A retrospective analysis of all IBGs performed on patients with ESRD at a single tertiary care institution during the interval 1993 to 1999 was undertaken. The comparison groups consisted of concurrent series of patients with elevated creatinine (creatinine level > 1.2 mg/dL) and patients with normal renal function undergoing IBG. Procedural variables, angiographic runoff scores, and extent of tissue necrosis at presentation were correlated with outcome. Categoric parameters were compared with chi(2) analysis; rates were computed with life-table analysis., Results: Of an overall cohort of 622 IBGs performed during this interval, 78 IBGs (12.5%) were performed on 60 patients with ESRD, with a perioperative mortality rate of 1.3% that was comparable to controls. All reconstructions in the ESRD cohort were for limb salvage indications. Four-year survival, primary, assisted primary, and secondary patency rates for the ESRD group were 51% +/- 9%, 60% +/- 11%, 86% +/- 5%, and 86% +/- 5%, respectively; these were not statistically different from the control groups. Limb salvage in the ESRD group was 77% +/- 6% at 4 years and was significantly less then either the elevated creatinine (92% +/- 4%; P <.02) or the normal renal function group (90% +/- 2%: P <.02). Of 16 amputations in the ESRD group, nine were performed in limbs with patent grafts. The only absolute predictor of limb loss despite a patent graft was the presence of a heel ulcer more than 4 cm in diameter. Age, runoff score of the International Society for Cardiovascular Surgery/Society for Vascular Surgery, isolated tibial bypass graft, and location of distal anastomosis were not predictive of hemodynamic failure., Conclusions: Patients with ESRD constitute an increasing proportion of patients undergoing IBG in a tertiary care setting. Four-year survival, perioperative mortality, and graft patency rates are similar to patients with normal renal function and support an aggressive approach to this population. Major limb amputation despite a patent graft remains a problem of unique frequency in patients with ESRD. Adequate predictors of hemodynamic failure of IBG in this group do not exist, although a heel ulcer more than 4 cm may indicate an unsalvageable foot.