FDA-Approved Sodium Tetradecyl Sulfate (STS) versus Compounded STS for Venous Sclerotherapy

BACKGROUND: In the area of endovenous chemical ablation (sclerotherapy), there has been much debate regarding sclerosant quality and efficacy. Only sodium tetradecyl sulfate (STS) has garnered Food and Drug Administration (FDA) approval in the United States. OBJECTIVE: The primary objective of this study was to compare clinical performance measures of compounded STS from 27% industrial-strength stock (compounded STS) versus FDA-approved Sotradecol (Bioniche Pharma USA, Inc., Belleville, Ontario, Canada). MATERIALS AND METHODS: Phase I of this study focused on the chemical composition of the drugs, whereas Phase II studied the ablative abilities of the two drugs at comparable concentrations of 3%. RESULTS: We documented the presence of various impurities in compounded STS. No impurities in AngioDynamics STS were found. Our studies suggest that compounded STS may have significant variation in concentration. The AngioDynamics STS concentration was found to be manufactured within a tight tolerance. Segments of incomplete ablation were more frequent in the compounded STS group when compared to the AngioDynamics STS group. This reached statistical significance (p=.02). Primary closure using the Kaplan-Meier statistic demonstrated a trend in the favor of AngioDynamics STS when compared to compounded STS. CONCLUSION: When product quality, efficacy, and liability are carefully considered, we conclude that it would behoove physicians to use pharmaceutical-grade, FDA-approved sclerosant when treating their patients.     

Extended Lateral Supramalleolar Flap for Very Distal Foot Coverage: A Case With Arteriovenous Malformation

Arteriovenous malformation of the foot is very uncommon, and surgical closure after its treatment with embolization and total excision may be challenging for the foot surgeon, particularly in distally localized lesions. A popular method to cover these difficult wounds is free-tissue transfer, which is a highly demanding procedure. Alternatively, distally based regional flaps have been occasionally reported for clinical use in such distant foot defects. Herein, we present a 36-year-old female patient with a diagnosis of arteriovenous malformation arising in the distal medial plantar and dorsal surfaces of the right foot. After surgical resection of the vascular lesion preceded by a misapplied embolization procedure, an extended lateral supramalleolar flap was successfully transferred to the defect area, covering it completely. Functional and aesthetic outcome was satisfactory after 6 months follow-up. Extended lateral supramalleolar flap is a useful and reliable choice for distal foot reconstructions.     

Skin cancers and precancerous lesions in Parkinson's disease patients.

Our objective was to evaluate the frequency of neoplastic and preneoplastic skin lesions in Parkinson's disease (PD) patients when compared with an aged-matched population. We performed a cross-sectional survey in PD patients and in an age-matched control group. Patients and controls were examined by a movement disorder specialist and a dermatologist. 150 PD patients and 146 controls were included. Thirty-five PD patients (23.3%) presented skin lesions that could be classified as neoplastic or preneoplastic vs. 20 subjects in the control group (13.7%) (OR 95%, CI 1.92 [1.05, 3.51]). However, this difference lost statistical significance when adjusted for gender (recruitment of controls was matched just for age with an over representation of males in the PD group). Twenty-nine PD patients (19%) presented actinic keratosis and basal cell carcinoma was diagnosed in 4 patients (3%). Although nonconclusive, our results are in agreement with previous studies suggesting an increased risk of skin cancer in PD patients. The frequency of actinic keratosis in PD patients and the associated risk to develop melanoma recommends its screening in future epidemiological studies.