SCLEROSOL SUMMARY
Sclerosol® Intrapleural Aerosol (sterile talc powder 4 g) is a sclerosing agent for intrapleural administration supplied as a single-use, pressurized spray canister with two delivery tubes of 15 cm and 25 cm in length. Each canister contains 4.0 g of talc, either white or off-white to light grey, asbestos-free, and brucite-free grade of talc of controlled granulometry. The composition of the talc is ≥ 95% talc as hydrated magnesium silicate.
Sclerosol® Intrapleural Aerosol, administered by aerosol during thoracoscopy or open thoracotomy, is indicated to prevent recurrence of malignant pleural effusions in symptomatic patients.
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NEWS HIGHLIGHTS
Published Studies Related to Sclerosol (Talc Intrapleural)
Lung injury following thoracoscopic talc insufflation: experience of a single North American center. [2010.06]
BACKGROUND: Thoracoscopic talc insufflation (TTI) has been used to obliterate the pleural space and prevent recurrent pleural effusions or pneumothorax. Reports of acute pneumonitis and ARDS after the use of talc raised concern about its safety. Differences in particle size of various talc preparations may explain the variable occurrence of pneumonitis. We sought to determine the incidence of lung injury after TTI over a 13-year period at our institution... CONCLUSIONS: We report the occurrence of lung injury after TTI using the only talc approved by the US Food and Drug Administration. These results reinforce previous concerns regarding the talc used for pleurodesis in North America.
Acute inflammatory response secondary to intrapleural administration of two types of talc. [2010.02]
Intrapleural instillation of talc has been used in the treatment of recurrent pleural effusions but can, in rare instances, result in respiratory failure. Side-effects seem to be related to composition, size and inflammatory power of talc particles... In conclusion, talc with larger particles should be the preferred choice in clinical practice in order to induce safer pleurodesis.
A comparison of the effectiveness of talc, polidocanol and ethanol as pleural sclerosing agents in rabbits. [2009.03]
BACKGROUND: Aim of the study was to compare the pleurodesis results from the intrapleural injection of talc, polidocanol and ethanol into the rabbit pleura... CONCLUSION: The intrapleural injection of polidocanol produces better pleurodesis than does the intrapleural injection of talc or ethanol in rabbits. Because of the efficacy of polidocanol as a sclerosing agent, its use in humans should be considered after further animal studies.
Talc pleurodesis: evidence of systemic inflammatory response to small size talc particles. [2009.01]
The mechanisms of the systemic response associated with talc-induced pleurodesis are poorly understood. The aim of this study was to assess the acute inflammatory response and migration of talc of small size particles injected in the pleural space...
Pleural mesothelial cells mediate inflammatory and profibrotic responses in talc-induced pleurodesis. [2007.12]
Intrapleural talc is used to produce pleurodesis in malignant pleural effusions...
Clinical Trials Related to Sclerosol (Talc Intrapleural)
Talc Pleurodesis in Patients With Recurrent Malignant Pleural Effusion [Completed]
The purpose of this study is to analyze and compare radiological lung expansion after talc
pleurodesis performed either by videothoracoscopy or chest tube and correlate it with
clinical outcome. Secondary endpoints evaluated were: clinical efficacy, safety, quality of
life and survival.
Comparison of Thoracoscopic Talc Pleurodesis by Thoracic Epidural or General Anesthesia [Completed]
Video-assisted thoracoscopic surgery (VATS) talc pleurodesis is often carried out in
patients with malignant recurrent pleural effusion to relieve symptoms and prevent
recurrence.
General anesthesia and one lung ventilation is the standard type of anesthesia employed for
VATS although recently, thoracic epidural anesthesia (TEA) in awake spontaneously
ventilating patients is being increasingly employed to perform several cardio-thoracic
surgery procedures in an attempt of minimize operative risks and facilitate resumption of
daily-life activity.
The investigators have reasoned that for a simple and palliative procedure such as talc
pleurodesis in cancer patients is, use of general anesthesia and one-lung ventilation might
be considered a potential cause of morbidity and delayed recovery. The investigators have
also hypothesized TEA could be considered an optimal type of anesthesia in this setting
leading to a fast recovery a reduced overall workload in medical care.
In this single-center randomized study, the investigators have comparatively assessed the
impact of awake TEA versus general anesthesia and one-lung ventilation on comprehensive
results of VATS talc pleurodesis.
Efficacy of Baby Talcum in Prevention of Pruritus Assosiated With Cast [Enrolling by invitation]
This study aims to evaluate the efficacy of baby talcum in prevent pruritus after cast
application in orthopaedic patients.
The investigators will do a randomized controlled trial in patient with fracture distal end
of radius treated conservatively.
Pruritus score and satisfaction will be monitor along the entire course of cast retention.
A Prospective Randomised Study of Efficacy, Safety and Costs of Talc Pleurodesis Under Medical Thoracoscopy and Pleurodesis Under Video-assisted Thoracoscopy Surgery for Recurrent Primary Spontaneous Pneumothorax [Completed]
Video-Assisted Surgery or Talc Pleurodesis in Treating Patients With Malignant Mesothelioma [Completed]
RATIONALE: Video-assisted surgery to remove part of the tissue layer covering the inside of
the chest cavity may be effective in treating pleural effusion and cause less damage to
normal tissue. Talc pleurodesis may keep fluid from building up in the chest cavity. It is
not yet known which therapy is more effective in treating pleural effusion caused by
malignant mesothelioma.
PURPOSE: This randomized phase III trial is studying video-assisted surgery to see how well
it works compared with talc pleurodesis in treating patients with malignant mesothelioma.
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