Track topics on Twitter Track topics that are important to you
The purpose of this study is to determine whether betadine (povidone-iodine) instillation during routine indwelling Tunneled Pleural Catheter (TPC) placement is efficacious in promoting pleurodesis and thus reducing the time to TPC removal.
Tunneled pleural catheter (TPC) placement is a routine clinical procedure used in the setting of recurrent pleural effusions. The most common clinical indication is malignant pleural effusion but these can be used in benign pleural effusions as well (such as those due to congestive heart failure, cirrhosis, etc). The primary benefit of TPC placement is relief of dyspnea without the need for recurrent procedures.
Despite success at relieving dyspnea, there are problems with the long-term placement of TPC's. One risk is infection which is estimated at 5%. Furthermore, each drainage kit costs approximately $100 and is often paid out-of-pocket by patients. Over time, this may create a substantial cost burden. Finally, most patients who undergo TPC placement require home drainage by visiting nurses. This is a significant resource utilization and it often requires interruption of a patient's home routines via the visitation requirements.
Occasionally, the effusion no longer reaccumulates following TPC placement. In malignant effusions, this pleurodesis (see below) occurs up to 50% of the time in malignant effusions. When pleurodesis occurs, the TPC may be removed by a simple office procedure.
Pleurodesis, or the act of inducing scarring and obliteration of the potential space between the visceral and parietal pleura where pleural effusions develop, is a different mechanism of providing relief of dyspnea. In the USA in particular, the most common agent used for pleurodesis (talc) is associated with complications such as respiratory failure and adult respiratory distress syndrome (ARDS), a life-threatening condition. Talc is also very expensive.
Povidone-Iodine, an agent used for pleurodesis in many other countries, has been shown to be highly efficacious when given via other modalities. Studies report a pleurodesis rate of 90+% with Povidone-Iodine. It also has a favorable safety record and is inexpensive.
Given all of these factors, the investigators propose a prospective study using Povidone-Iodine at the time of TPC placement to promote pleurodesis. The investigators hypothesize that pleurodesis will occur quickly and frequently, thus enabling removal of the TPC, thereby saving cost, risks of infection, all while improving patients quality of life.
The investigators plan on doing this by enrolling patients prospectively who are to undergo TPC placement as part of their standard care. These patients would be prospectively enrolled and randomized to receive either usual care (no pleurodesis) or the investigational medication (povidone-iodine) intrapleurally at time of procedure. The investigators would subdivide groups prospectively between patients who have malignant pleural effusions and those who have benign (non-malignant) pleural effusions.
Following TPC placement and medication administration (if necessary), nursing and investigative physicians would then immediately follow them in the recovery area (to monitor for any negative immediate outcomes such as hypertension, hypotension, reactions, or significant pain) and in clinic as per their usual care (starting 1-2 weeks after discharge and as long as necessary). The investigators would monitor them for the outcomes as noted elsewhere.
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment
Not yet recruiting
Published on BioPortfolio: 2016-11-30T15:45:41-0500
Pleural effusion is an accumulation of fluid between the tissue layers that line the lungs and chest cavity. It has an estimated prevalence of 320 per 100,000 people in industrialized coun...
To determine if routinely available 10% povidone-iodine swabs are more effective than saline and 3M Skin and Nasal Antiseptic 5% Povidone-Iodine USP for decolonizing MRSA.
Pleural effusion is a common complication of cardiac surgery. The aim of this study was to determine the prevalence, characteristics and determinants of clinically significant pleural effu...
The aim of this study is the feasibility assessment of a simple and affordable model for the quantification of Pleural Effusion through thoracic Ultra Sounds images. Two US scans will be p...
The investigators have few options for skin antisepsis. Alternatives for povidone-iodine, which is the most commonly used agent, are costly or ineffective. To have more options, this study...
To determine the minimum effective concentration of povidone-iodine that reduces the bacterial load by 3-log10, the U.S. Food and Drug Administration requirement for antiseptic agents, and to study al...
The aim of the present study was to investigate the effect of povidone-iodine (PVP-I) application at delivery on maternal urinary iodine concentration (UIC) and neonatal thyrotropin concentration.
The cause of pleural effusion remains uncertain in approximately 15% of patients despite exhaustive evaluation. As recently described IgG4-related disease is a fibroinflammatory disorder that can affe...
Estimation of the pleural effusion's volume is an important clinical issue. The existing methods cannot assess it accurately when there is large volume of liquid in the pleural cavity and/or the patie...
The most efficient and cost-effective approach for the diagnosis of pleural exudates remains uncertain and is a subject of controversy. Essential factors to be considered include the respective diagno...
Presence of fluid in the pleural cavity resulting from excessive transudation or exudation from the pleural surfaces. It is a sign of disease and not a diagnosis in itself.
An iodinated polyvinyl polymer used as topical antiseptic in surgery and for skin and mucous membrane infections, also as aerosol. The iodine may be radiolabeled for research purposes.
Presence of fluid in the PLEURAL CAVITY as a complication of malignant disease. Malignant pleural effusions often contain actual malignant cells.
Preparations used as alternatives or supplements to hand washing with soap and water to destroy microorganisms and prevent transmission of pathogens. The active ingredient may be ETHANOL; 1-PROPANOL; or POVIDONE-IODINE in a gel, foam, or liquid solution.
Surgical creation of an opening (stoma) into the chest cavity for drainage; used in the treatment of pleural effusion, pneumothorax, hemothorax and empyema.