Polidocanol Research Articles

Injectable agents for the induction of Peyronie's disease in model rats: a comparative study.

Peyronie's disease (PD) is a disorder characterized by fibrous plaque formation in the penile tissue that leads to curvature and complications in advanced stages. In this study, we aimed to compare four injectable induction agents for the establishment of a robust rat model of PD: transforming growth factor-β1 (TGF-β1), fibrin, sodium tetradecyl sulfate (STS) combined with TGF-β1, and polidocanol (POL) combined with TGF-β1. The results showed that injection of TGF-β1 or fibrin into the tunica albuginea induced pathological endpoints without causing penile curvature. The STS + TGF-β1 combination resulted in both histological and morphological alterations, but with a high incidence of localized necrosis that led to animal death. The POL + TGF-β1 combination produced pathological changes and curvature comparable to STS + TGF-β1 and led to fewer complications. In conclusion, fibrin, STS + TGF-β1, and POL + TGF-β1 all induced PD with a certain degree of penile curvature and histological fibrosis in rats. The POL + TGF-β1 combination offered comparatively greater safety and clinical relevance and may have the greatest potential for PD research using model rats.

Effect of catheter needle caliber on polidocanol foam stability in foam sclerotherapy.

Although sclerotherapy is widely used to treat vascular malformations (VMs), it is associated with several challenges. One significant issue is the insufficient understanding of the influence of various factors on the stability of polidocanol (POL) foam used in sclerotherapy. This study aimed to explore the effect of the catheter needle caliber on foam stability when using POL with or without hyaluronic acid (HA) for the treatment of VMs. The Tessari method generated sclerosant foam using POL both with and without HA. We used catheters and syringe needles of various calibers, and the resulting foam was transferred into new syringes to facilitate a comparison of foam stability. Foam half-life (FHT) was utilized as a metric to assess foam stability. The study found that narrower needle calibers produced a more stable foam when POL was used alone; however, no significant effect was observed when HA was added. Furthermore, when the foam was expelled using catheters and syringe needles of the same size, no noticeable changes in the stability were observed. When choosing needles of varying calibers, their effect on foam stability should be carefully considered, particularly when the foam contains HA.

The Effect of Pushing Rate on Foam Stability in the Tessari Method.

The Tessari method is commonly used in sclerotherapy for producing foam, involving 2 syringes pushed back and forth 20 times with the use of a 3-way connector. Many factors affect the foam stability which is crucial for clinical efficacy. This study aimed to identify the optimal pushing rate which may impact the foam stability. Polidocanol (POL) solution (1% and 3%) was used to make sclerosant foam via the Tessari method, with a total of 20 pushes performed at different time durations: 10, 15, 20, 25, 30, 35, and 40 seconds. The foam stability was recorded using foam half-life time (FHT), and the pushing pressure to the syringe was recorded using a self-made electric device. Both FHT and the pressure among different groups were compared respectively. The FHT was decreased as pushing duration exceeding 20 seconds in POL 1% and 15 seconds in POL 3%. Both the highest FHT and pressure point were located in the 10-second group. It is recommended to complete 20 back-and-forth passages within 10 seconds to create stable foam.

Study of vascular sclerosing agent based on the dual mechanism of vascular endothelial cell damage-plasmin system inhibition

Venous malformations are a vascular disorder. Currently, the use of chemical sclerosing agents is a common clinical approach for the treatment of venous malformations. However, the effectiveness of existing sclerosing agents is unsatisfactory and often accompanied by severe side effects. In this study, we have developed a novel cationic surfactant-based sclerosing agent (POL-TA) by conjugating the plasmin inhibitor tranexamic acid (TA) with a nonionic surfactant polidocanol (POL) through an ester bond. POL-TA induces endothelial cell damage, triggering the coagulation cascade and thrombus formation. Moreover, it releases TA in vivo, which inhibits plasmin activity and the activation of matrix metalloproteinase (MMPs), thereby stabilizing the fibrin network of the thrombus and promoting vascular fibrosis. We have established a cell model using venous malformation endothelial cells and assessed the cellular damage and underlying mechanisms of POL-TA. The inhibitory effects of POL-TA on the plasmin-MMPs system were evaluated using MMP-9 activity assay kit. Additionally, the mice tail vein model was employed to investigate the vascular sclerosing effects and mechanisms of POL-TA.

A comparison of patient-reported outcome measures following technical success and technical failure in the treatment of great saphenous vein incompetence using ClariVein: A subanalysis of a multicenter randomized controlled trial comparing 2% and 3% polidocanol.

This study aimed to compare patient-reported outcomes after technical success (TS) and technical failure (TF) in treating great saphenous vein incompetence (GSV) with ClariVein. A subanalysis of a previous trial was conducted on symptomatic GSV incompetence patients who received ClariVein treatment with 2% or 3% polidocanol (POL) and were followed for 6months. Blinding was implemented for observers and patients, and data from both POL groups were combined. TS was defined as at least 85% occlusion of the treated vein, while TF indicated failure to meet TS criteria. Secondary outcomes included Venous Clinical Severity Score (VCSS), Aberdeen Varicose Vein Questionnaire (AVVQ), and Short-Form 36 Health Survey Questionnaire (SF-36). Among the 364 patients included, the TS rate was 64.5%. Comparison of VCSS, AVVQ, and SF-36 scores between TS and TF groups did not yield significant differences. This study indicates no significant variation in VCSS, AVVQ, and SF-36 scores between patients experiencing TS and TF following ClariVein treatment for GSV insufficiency.

The role of hyaluronic acid in polidocanol foam: An in vitro study.

To study the role of hyaluronic acid (HA) in polidocanol (POL) foam. The dose-dependent effect of HA-POL on cultured human umbilical vein endothelial cells (HUVECs) as well as foam stability was evaluated by measuring optical density (OD) values and foam half-life time (FHT), respectively. An in vitro model was utilized for estimating the foam blood-displacement capacity by adopting maximum displacement distance (MDD) and displacement time. A comparison of foam viscosity was also carried out. The OD values of HUVECs treated with HA first increased and then decreased with the growing dosage of HA while cells treated with HA-POL died. Both FHT and displacement time were prolonged statistically with a gradually enhanced foam viscosity. As to MDD, there were no significant differences. HA was found to promote HUVECs proliferation slightly, but this was almost negligible when compared to the cell-killing capacity of 1% POL. The viscosity of POL foam was enhanced by HA indicating its positive correlation with both stability and displacement capacity of POL foam.

Comparison of Foaming Properties Between the Shirasu Porous Glass Membrane Device and Tessari’s Three-way Stopcock Technique for Polidocanol and Ethanolamine Oleate Foam Production: A Benchtop Study

PurposeTo compare the characteristics of polidocanol (POL) and ethanolamine oleate (EO) sclerosing foams produced by a Shirasu porous glass membrane (SPGM) device with those made using a 3-way stopcock (3WSC). Materials and MethodsFoam half-life times were measured in an ex-vivo benchtop study. Computed tomography (CT) images of each foam were obtained over the time course, and a CT texture analysis was conducted. The bubble size in each foam was measured by an optical microscope. ResultsMedian foam half-life times were longer in the SPGM group than in the 3WSC group (POL: 198 vs 166 s, P = .02; EO: 640 vs 391 s, P < .01). In the CT texture analysis, median standard deviation (SD) and entropy (randomness) were lower, and median energy (uniformity) and gray-level cooccurrence matrix (GLCM) homogeneity were higher in the SPGM group than in the 3WSC group (POL SD: at 30 s and 50–300 s; POL entropy: at 0–60 s; EO SD: at 0–600 s; EO entropy: at 0–460 s; POL energy: at 0–40 s; POL GLCM homogeneity: at 0–250 s; EO energy: at 0–360 s; EO GLCM homogeneity: at 0–480 s; all P < .05). Median bubble diameters in the SPGM group and in the 3WSC group were 69 and 83 μm (P < .01), respectively, in the POL foam; and 36 and 36 μm (P = .45), respectively, in the EO foam. ConclusionsPOL and EO foams had greater uniformity and longer foam half-life time when prepared with an SPGM device than with a 3WSC.

A multicenter, randomized, dose-finding study of mechanochemical ablation using ClariVein and liquid polidocanol for great saphenous vein incompetence

BackgroundThe purpose of the present study was to identify the ideal polidocanol (POL) concentration for mechanochemical ablation (MOCA) of the great saphenous vein (GSV) using the ClariVein system (Merit Medical, South Jordan, Utah). MethodsWe performed a multicenter, randomized, controlled, single-blind trial with a follow-up period of 6 months. Patients with symptomatic primary truncal GSV incompetence were randomized to MOCA + 2% POL liquid (2% group) or MOCA + 3% POL liquid (3% group). The primary outcome was technical success (TS), defined as an open part of the treated vein segment of ≤10 cm in length. The secondary outcomes were alternative TS, defined as ≥85% occlusion of the treated vein segment, postoperative pain, venous clinical severity scores, Aberdeen varicose vein questionnaire scores, and short-form 36-item health survey questionnaire scores, and complications. ResultsFrom 2012 to 2018, 364 patients (375 limbs) were included, of which, 189 limbs were randomly allocated to the 2% group and 186 to the 3% group. The TS rate at 6 months was 69.8% in the 2% group vs 78.0% in the 3% group (P = .027). A higher overall TS rate was seen in GSVs of ≤5.9 mm compared with GSVs >5.9 mm (84.3% vs 59.5%, respectively; P < .001). The alternative TS rate at 6 months was 61.4% in the 2% group and 67.7% in the 3% group (P = .028). The venous clinical severity scores, Aberdeen varicose vein questionnaire scores, and most short-form 36-item health survey questionnaire domains had improved in both groups (P < .002). Postprocedural pain was low. Two pulmonary embolisms and two deep vein thromboses were seen. Superficial venous thrombosis had occurred more often in the 3% group (18 vs 8 in the 2% group; P = .033). ConclusionsThe results from the present study showed a higher success rate for MOCA with 3% POL liquid than for MOCA with 2% POL liquid at 6 months of follow-up. However, the difference in quality of life was not significant. Long-term follow-up studies are required to investigate whether these results will be sustained in the future.

LIPIODOL reduces the lytic activity of detergent sclerosants in vitro.

Contrast agents are used widely in the interventional setting and in particularly in the management of vascular anomalies and have also been used in combination with sclero-embolic agents. There is limited information on the interaction of contrast agents with sclerosant agents when used as mixtures. The aim of this study was to determine the effect of mixing radiological contrast agents with detergent sclerosants and measuring the effect on change in lytic activity of detergent sclerosants in vitro and by proxy the change in potency. Red blood cell lysis was assessed following the incubation of two commonly used contrast agents, LIPIODOL® and ULTRAVIST®, mixed with detergent sclerosants, FIBROVEIN®, sodium tetradecyl sulfate (STS), and AETHOXYSKLEROL®, polidocanol (POL). The density of both contrast agents was higher than STS and POL and neither of the detergent sclerosants were miscible in LIPIODOL. LIPIODOL on its own caused cell lysis (1.01%, p < 0.05) whereas ULTRAVIST did not. Fifty per cent cell lysis for sclerosant and LIPIODOL mix occurred at concentrations of: 0.041% (2.4 times greater than the control, p < 0.05) and 0.08% (3.6 times greater than the control, p = 0.06) for STS and POL, respectively. LIPIODOL, when mixed with sclerosant detergents (ratio 1:1) causes a reduction in the lytic activity of sclerosants and this effect was statistically significant and most prominent in lower sclerosant concentration mixtures.

Foam bubble size is significantly influenced by sclerosant concentration for polidocanol but not sodium tetradecyl sulphate

To determine the effect of liquid gas fraction (LGF), sclerosant type and concentration, and filter use on foam bubble size and count. Sclerosant foam microstructure was investigated using light microscopy for a range of LGFs (1 + 2, 1 + 4 and 1 + 8), for both sodium tetradecyl sulphate (STS) and polidocanol (POL), at a range of concentrations (0.5-3%), with and without the addition of micro-filters. Foam was generated using a modified Tessari method and placed into wells for analysis by light microscopy. Foam microscopic morphology was photographically documented, and bubble diameters and counts were quantified. Spherical bubbles were observed at lower LGF and a trend towards polyhedral morphology was observed at the higher LGF of (1 + 8). The higher gas content in LGF led to larger but fewer bubbles. POL bubble diameters appeared to be more influenced by concentration than STS with smaller bubbles observed at higher concentrations of POL. The mean bubble diameters were slightly larger for STS than POL at the highest concentration of 3% but smaller at lower concentrations of 1% and 1.5%. LGF is the primary determinant of bubble diameter and count. In contrast to STS, POL concentration influences the foam bubble size with smaller bubbles generated at higher concentrations of POL and larger bubbles appearing at low concentrations of this agent.

Sclerotherapy

Sclerotherapy involves the injection of a caustic solution into an abnormal vein so as to cause localized destruction of the venous intima and obliteration of the vessel. Over the past 50 years, improvements in the technology have greatly enhanced the results achievable with sclerotherapy. To ensure optimal results, it is essential to have a thorough knowledge not only of the technique but also of the indications, expected outcomes, and possible complications associated with the procedure. This review covers preoperative evaluation, operative planning, technique and complications associated with sclerotherapy. Figures show a 63-year-old woman before and after two treatments with 0.2% sodium tetradecyl sulfate, a 52-year-old woman before and after two treatments with 0.5% sodium tetradecyl sulfate, a 36-year-old woman before and after four treatments with a combination of 0.5% and 0.2% sodium tetradecyl sulfate, the standard hand position for sclerotherapy, skin necrosis on the left posterior calf of a 48-year-old woman after ultrasound-guided sclerotherapy, a 56-year-old woman before treatment and with residual hyperpigmentation after treatment with 0.2% sodium tetradecyl sulfate, and telangiectatic matting in a 43-year-old woman after treatment with 0.2% sodium tetradecyl sulfate. Tables list complications of sclerotherapy, suggested polidocanol (POL) and sodium tetradecyl sulfate (STS) concentrations for liquid and foam sclerotherapy, materials needed for sclerotherapy, and absolute and relative contraindications for sclerotherapy for varicose veins. Key Words: Varicose veins, Chronic venous insuffiency, sclerotherapy, foam sclerotherapy, reticular veins, venous disorders This review contains 7 highly rendered figures, 4 tables, and 29 references.

Sclerotherapy

Sclerotherapy involves the injection of a caustic solution into an abnormal vein so as to cause localized destruction of the venous intima and obliteration of the vessel. Over the past 50 years, improvements in the technology have greatly enhanced the results achievable with sclerotherapy. To ensure optimal results, it is essential to have a thorough knowledge not only of the technique but also of the indications, expected outcomes, and possible complications associated with the procedure. This review covers preoperative evaluation, operative planning, technique and complications associated with sclerotherapy. Figures show a 63-year-old woman before and after two treatments with 0.2% sodium tetradecyl sulfate, a 52-year-old woman before and after two treatments with 0.5% sodium tetradecyl sulfate, a 36-year-old woman before and after four treatments with a combination of 0.5% and 0.2% sodium tetradecyl sulfate, the standard hand position for sclerotherapy, skin necrosis on the left posterior calf of a 48-year-old woman after ultrasound-guided sclerotherapy, a 56-year-old woman before treatment and with residual hyperpigmentation after treatment with 0.2% sodium tetradecyl sulfate, and telangiectatic matting in a 43-year-old woman after treatment with 0.2% sodium tetradecyl sulfate. Tables list complications of sclerotherapy, suggested polidocanol (POL) and sodium tetradecyl sulfate (STS) concentrations for liquid and foam sclerotherapy, materials needed for sclerotherapy, and absolute and relative contraindications for sclerotherapy for varicose veins. Key Words: Varicose veins, Chronic venous insuffiency, sclerotherapy, foam sclerotherapy, reticular veins, venous disorders This review contains 7 highly rendered figures, 4 tables, and 29 references.

Effect of Hyaluronic Acid and Pluronic-F68 on the Surface Properties of Foam as a Delivery System for Polidocanol in Sclerotherapy.

The use of foams to deliver bioactive agents and drugs is increasing in pharmaceutics. One example is the use of foam as a delivery system for polidocanol (POL) in sclerotherapy, with the addition of bioactive compounds to improve the delivery system being a current subject of study. This work shows the influence of two bioactive additives on the structure and stability of POL foam: hyaluronic acid (HA) and Pluronic-F68 (F68). HA is a natural non-surface-active biopolymer present in the extracellular matrix while F68 is a surface-active poloxamer that is biocompatible with plasma-derived fluids. Both additives increase the bulk viscosity of the sample, improving foam stability. However, HA doubled and F68 quadruplicated the foam half lifetime of POL. HA reduced the size and polydispersity of the bubble size distribution and increased the surface elasticity with respect to POL. Both facts have a positive impact in terms of foam stability. F68 also altered bubble structure and increased surface elasticity, again contributing to the enhancement of foam stability. The surface characterization of these systems is important, as in foam sclerotherapy it is crucial to assure the presence of POL at the surface of the bubbles in order to deliver the sclerosant agent in the target vein.

A Novel Compound Sclerosant: Polidocanol-Bleomycin Foam.

Foam sclerotherapy is an effective treatment strategy for venous malformations. Both polidocanol (POL) and bleomycin are effective sclerosants; however, no studies have reported POL-bleomycin foam. To introduce a method for producing POL-bleomycin foam and evaluate the stability of POL-bleomycin foam with bleomycin concentrations. Group A: 2 mL of 1% POL + 8 mL of air; Group B: 2 mL of 1% POL + 3 U bleomycin + 8 mL of air; Group C: 2 mL of 1% POL + 6 U bleomycin + 8 mL of air; Group D: 2 mL of 1% POL + 12 U bleomycin + 8 mL of air. Tessari method was used for foam generation. The foam half-life time (FHT) was used to evaluate foam stability. Five recordings were made for each group. The FHT was 148.6 ± 2.9 seconds in Group A, 148.8 ± 4.0 seconds in Group B, 148.4 ± 2.6 seconds in Group C, and 148.8 ± 1.6 seconds in Group D. The FHT in different groups showed no significant differences. The POL-bleomycin foam was prepared successfully and its FHT was as long as the POL foam.

An innovative spectrophotometric method for determination of polidocanol in pharmaceutical ampoules using phase equilibrium measurements

A simple spectrophotometric method was developed for determination of the challenging surface active non-chromophoric pharmaceutical product; polidocanol (PD). The assay principle depends on the ability of PD to form a ternary complex with the tetrahedral cobalt (II)-thiocyanate blue complex, due to the poly(ethylene oxide) group. The hydrophobic chain in PD allows the formed ternary complex to be extracted in the dichloromethane layer, which turns blue after addition of PD and shaking. The absorbance of the extracted ternary complex can be monitored to measure the concentration of PD. The proposed method was found selective and suitable for determination of PD in pharmaceutical dosage forms, with no interference from excipients. The different factors that may affect the method sensitivity were studied, including the type of extractant, the wavelength, the complex concentration, the mixing and the extraction time. The maximum sensitivity was attained when the absorbance was measured at 320 nm using dichloromethane as an extractant, and 3 M of ammonium thiocyanate mixed with PD for 2 min and extracted for 2 min. The developed method was validated according to the ICH guidelines, the calibration curve was constructed with a correlation coefficient of 0.999 in a concentration range of 50–400 µg/mL. The method was able to specifically detect and quantify PD in bulk with a %recovery 100.55% ± 0.29 and in its commercial dosage form with a %recovery of 100.30 ± 1.04.

A Review of Sclerosing Foam Stability in the Treatment of Varicose Veins.

Varicose veins are common clinical entities. Foam sclerotherapy is a minimally invasive and simple procedure; however, the side effects, efficacy, and stability of sclerosing foam are not ideal. To summarize the current studies on sclerosing foam stability and promote foam sclerotherapy development. We reviewed the literature before June 2018 and included only representatives studies on sclerosing foam stability. We summarized the foam half-life time (FHT) of polidocanol (POL) under 17 preparation conditions and the FHT of sodium tetradecyl sulfate under 21 preparation conditions. The preparation conditions included various combinations of temperature, liquid-gas ratio, preparation method, etc. RESULTS: The FHT of POL varied between 40 and 4,000 seconds under different conditions. The FHT of sodium tetradecyl sulfate varied from 25.7 to 390 seconds. The higher the drug concentration, the lower the temperature required to increase foam stability. The addition of surfactant greatly increased foam stability. For different gas compositions, the FHT sequence was as follows: CO2 < CO2 + O2 < O2 < air. Foam stability can be improved by changing the preparation conditions; therefore, the role of surfactants and predictive methods for FHT are worth investigating further.

Single Blind, Randomised Study Regarding the Treatment of the Telangiectasia of the Lower Limbs (C1EAP) Using Polidocanol 0,5%, 1%, and Nd:YAG Laser.

The treatment of leg telangiectasias could be done with liquid sclerotherapy or Nd:YAG laser. We evaluated randomly, in a simple blind, the efficacy of the treatment with 0,5% polidocanol (POL-0,5), 1% polidocanol (POL-1) and Nd:YAG laser (LAS) on 132 patient (264 limbs) with telangiectasia of the lower limbs with less than 2mm diameter (C1EAP). The main objective was to evaluate the efficacy of the sclerotherapy (chemical compared with Nd:YAG-LAS). Secondary objectives were: possible major complications (deep thrombosis, severe burns, ischemic complications, etc.), the percentage of the local complications, the cosmetic aspect-evaluated by both the patient and the doctor and the grade of discomfort of the patient during and after the procedure. Comparing the treatment with Nd:YAG laser (LAS), polidecanol-0.5% (POL-0.5), polidecanol 1% (POL-1), it was noticed that telangiectasias smaller than 1mm led to good and very good results in all the cases treated with Nd:YAG laser and the same outcome was obtained in one third of the subjects treated with POL-0.5, vs. 47.81% of patients treated with POL-1. When telangiectasias were larger than 1mm diameter, good and very good results occurred in 86.36% of patients treated with LAS and 100% of the cases treated with POL-0.5 and POL-1. In conclusion, we consider that leg telangiectasias can be treated with good results using Nd:YAG laser or sclerotherapy with polidocanol, Nd:YAG laser being reccomended for telangiectasia under than 1 mm diameter while sclerotherapy in larger vessels.

Therapeutic effects of endoscopic foam sclerotherapy for bleeding internal hemorrhoids

Objective To evaluate the safety and efficacy of foam sclerotherapy for bleeding internal hemorrhoids. Methods Consecutive adult patients (aged 18-60 years) with bleeding hemorrhoids were prospectively enrolled between March 2017 and March 2018. All patients were randomly assigned to the foam sclerotherapy (FS) group and the liquid sclerotherapy (LS) group. The foam and liquid sclerotherapy of hemorrhoids nucleus was performed by cap-assisted colonic endoscopy. Results A total of 108 patients were enrolled, including 62 males (57.4%) with mean age of 44.0±7.6 years. There was no significant difference in gender, age, or body mass index between the FS (n = 55) group and the LS (n =53) group. The total amount of lauromacrogol injection in the FS group was 3.7±0.9 mL, which was significantly lower than that in the LS group (8.0±2.2 mL, P<0.001). In the LS group, 8 patients (15.1%) developed bleeding after needle removal, which was significantly higher than that in the FS group [5.5%(3/53), P=0.022]. Significant pain was found in 2 patients (3.8%) in the LS group and 0 in the FS group (P= 0.025). The short-term cure rate and effective rate of the FS group were 87.3% (48/55) and 9.1% (5/55), while those were 69.8% (37/53) and 22.6% (12/53) in the LS group, respectively (P=0.046). Conclusion Foam sclerotherapy is safe and effective in the treatment of bleeding internal hemorrhoids. Key words: Hemorrhoids; Sclerosing solutions; Hemostasis, endoscopic; Sclerotherapy

Preliminary Experience With More Stable Polidocanol Foam in Sclerotherapy of Head and Neck Venous Malformations

Foam sclerotherapy is an effective treatment strategy for venous malformations (VMs). Stability is one of the characteristics of sclerosant foams that determine the sclerosing power. To evaluate the clinical outcomes of sclerotherapy with prolonged half-life of hyaluronic acid (HA)-polidocanol (POL) foam for treating head and neck VMs. Seventy patients with head and neck VMs were enrolled between October 2013 and January 2015 in Qilu Hospital Shandong University. Sclerotherapy was performed with prolonged half-life POL foam by addition of 0.05% HA. All patients were followed up at 1, 3, and 6 months. Reviews on the site and size of the lesion, times and duration of treatments, therapeutic response, and complications were performed to evaluate the end result. Sites of lesions included face, bucca, parotid region, neck, tongue, floor of mouth, lip, forehead, palate, and nose. An overall average of 2.5 treatments was required. Total response rate was 100%. "Resolution" was achieved in 21 cases (30%) and a significant response in 49 patients (70%). Immediate swelling was the most common complication. Epidermal extravasation was seen in 1 patient. Mucosal ulcer was observed in 1 patient. No generalized complications occurred. The prolonged half-life of HA-POL foam sclerotherapy of VMs in the head and neck is safe and effective.

A study to compare outcomes of Sodium tetra-decyl sulphate and Polidocanol in the treatment of varicosities due to incompetent tributaries of superficial vein of leg: a randomized controlled trial

Background: Various options for treatment of varicosities of tributaries are mini-phlebectomy, hook phlebectomy, Trivex and sclerotherapy. Sodium tetra-decyl sulphate (STD) and polidocanol (POL) are most commonly used sclerosants. Adverse events caused by sclerosants are pain, thrombophlebitis, hyperpigmentation, allergy, anaphylactic shock, cutaneous necrosis, deep venous thrombosis, headache, visual disturbances and chest tightness. Foam sclerotherapy has been considered to be better than liquid sclerosant. In this study we have compared foam prepared by STD versus POL in the treatment of varicosities of tributaries of superficial vein of Leg.Methods: Patients treated for SFJ or SPJ incompetency post their primary admission and management were attended and evaluated in outpatient department. Patients having varicosities were enrolled for study and treated in OPD by foam sclerotherapy. Patients were randomized to two groups - A or B. Patients were followed up for one month and various clinical outcomes were analyzed.Results: In group A (STD) out of n=20 patients pain, hyperpigmentation and skin necrosis was present in n1=18 patients, n2=14 patients and in n3=2 patients respectively on the first post-operative day while in group B (POL) out of 24 patients it was present in n1=14, n2=8 and n3=1 patient respectively. Post sclerotherapy at one month follow up, in Group A pain and hyperpigmentation decreased to n1=08 and n2=04 patients respectively but skin necrosis was persisting in all n3=02 patients. In-group B pain and hyperpigmentation was present in patients each n1= n2=02 and skin necrosis was present in n3=01 patient.Conclusions: Polidocanol is better than Sodium tetra-decyl sulphate for foam sclerotherapy in terms of better cosmetic outcomes.