Track topics on Twitter Track topics that are important to you
This clinical trial will compare survival of peripheral intravenous (IV) catheters for patients with a standard IV site dressing alone to patients with standard IV dressing plus Adhezion Biomedical SecurePortIV Catheter Securement Adhesive. Emergency room patients who already have IVs may be considered for inclusion. Eligible patients will be approached and, if they are interested in participating, their informed consent will be obtained. Participation will continue for up to 7 days. During this time, the patient will experience:
- Assessment of their currently placed peripheral IV catheter, to assess if it is functioning
- Assignment to one of two study groups (standard IV dressing or standard IV dressing plus Adhezion Biomedical SecurePortIV Catheter Securement Adhesive). This is called randomization and group assignment is by chance, like the flip of a coin
- Daily assessment of the IV catheter and site for complications (such as infection or phlebitis), removal, and medications being administered.
Patients admitted from the Emergency Department (ED) to a progressive floor are eligible participants. Research staff will approach patients admitted to the progressive floors based on screening of the electronic medical record. These patients are admitted to a progressive floor but approached by research staff when physically in the emergency department waiting for a room assignment. If the patient agrees to participate in the trial, the study subject will approached for consent by the research staff. Research staff will confirm functionality of the existing peripheral IV previously placed by ED staff. The assessment will include observing for blood return into the tubing upon aspiration and/or unobstructed flush with a minimum of 1-2 ml of normal saline. Staff will also observe the site for any signs of redness or tenderness. A tourniquet may be applied as needed. If the patient is actively receiving an infusion, the drip will briefly be halted to evaluate for functionality. Functionality will be assessed with the existing dressing in place. If the catheter is functional and free of any signs of complications, study subjects will be randomized by a computer generated 1:1 envelope system to either the control group: polyurethane dressing + clear tape or the experimental group: polyurethane dressing + clear tape + tissue adhesive. The tissue adhesive is not standard of care at Beaumont. For the control group, the polyurethane dressing will be gently removed. Dressing will be removed carefully to minimize any potential dislodgments or skin injury. The site will be evaluated for oozing or blood and as needed cleaned with sterile gauze. Once the site is completely dry, a new polyurethane dressing will be applied and reinforced with tape in a standard fashion. Once securement is complete, functionality will be reassessed per protocol above. For the experimental group, the existing securement will be gently removed. There are not special steps required for removing the dressing with the tissue adhesive. The IV catheter is secured and the dressing is removed gently. The site will be evaluated for oozing or blood and as needed cleaned with sterile gauze. Once the site is completely dry, the tissue adhesive will be applied. A new standard polyurethane dressing will be applied and tape will be applied per the standard approach. Once securement is complete, functionality will be reassessed. The time of the new dressing application will be noted as time zero. Catheter dwell time will begin at this point. Additional data variables collected at the initial assessment include: demographics such as age, sex, international normalized ratio (INR) >1.5, platelets < 50, insertion site details, hours from insertion to recruitment, inserter credentials.
After initial assessment, the catheter will be assessed by the research team every 24 hours as long as the patient is hospitalized up to 7 days or 168 hours. At each follow up interval the researcher notes the date /time of evaluation and assesses for any signs and symptoms of complications and functionality of the device. A catheter is functional if the IV flushes without resistance. Complications include infiltration, phlebitis, dislodgement, oozing fluid/blood, purulent drainage, or occlusion. Catheters will be assessed daily for signs and symptoms of complications. Any signs or symptoms of complications or lack of functionality will be reported to the patient's primary care team so that management of the IV catheter can be addressed. If the catheter was identified to have any signs or symptoms of complications during follow-up assessment the date and time of observation of the complication will be documented in the data collection tool and the primary team will be notified of the complication. If the catheter was removed prior to the follow-up assessment then the IV removal time and the reason for removal will be obtained through chart review. For all catheters removed due to a complication, re-insertion attempt data will be tracked through the medical record in the nursing section for venous lines and need for reinsertion of the IV or escalation to a midline, peripherally inserted central catheter (PICC), or central venous catheter (CVC) will be noted. If the patient is discharged prior to the time of follow-up assessment then the time of discharge will be documented and the IV will be presumed functional until time of discharge unless otherwise noted in the chart.
The medication administration record will be queried for all medications given through each catheter with specific attention to antibiotics and anticoagulants. Vesicants/irritants that are generally given via central line or considered caustic to the vessel will be noted in both groups. Number of doses will be recorded. Additional data gathered by research staff on follow-up evaluation includes: dwell time in days/hours, hospital length of stay, and number of peripheral IVs for duration of stay.
Vascular Access Devices
Standard IV dressing, Standard IV dressing plus a tissue adhesive peripheral IV securement device
Not yet recruiting
William Beaumont Hospitals
Published on BioPortfolio: 2019-09-17T02:47:35-0400
Continuous peripheral nerve block catheters are used for prolonged analgesia, but are often associated with complications such as catheter failure or dislodgement. This is a single center,...
The purpose of this study is to evaluate the efficacy of treatment with hydrofibre dressing in comparison with the efficacy of standard dressing in terms of prevalence of surgical site inf...
Use of dressing is common place following surgery, allowing for wounds to be covered and protected. Dressing material with adhesive contact layers or adhesive tape is integral to sealing o...
Evaluate the clinical performance of a new IV Dressing in Comparison to a standard IV Dressing
The purpose of this study is to determine whether using a pressure- vs. simple adhesive dressing affects the postoperative course and wound healing outcomes following Mohs surgery.
Dressing is an essential element of standard wound care. The main purpose of wound dressing is: a) provide a temporary protective physical barrier, b) absorb wound drainage, and c) provide the moistur...
Prolonged wound drainage after TKA is associated with increased risk of infection. To decrease wound drainage, tissue adhesive has been suggested as an adjunct to wound closure after TKA; however, no ...
Diabetic wound healing and angiogenesis remain a worldwide challenge for both clinic and research. The use of adipose stromal cells (ASCs) derived exosomes delivered by bioactive dressing provides a p...
Chitosan (CS) is a biodegradable and biocompatible polysaccharide that displays immune-stimulatory effects and anti-bacterial properties for facilitating wound closure. Over the years, different CS-ba...
Reconstruction of the nipple-areola complex is the culmination of a long road for patients who have suffered breast cancer. The postoperative dressing of the reconstructive nipple must protect it from...
The occupation concerned with the cutting and dressing of the hair of customers and, of men, the shaving and trimming of the beard and mustache. (From Random House Unabridged Dictionary, 2d ed)
The performance of the basic activities of self care, such as dressing, ambulation, or eating.
An autologous or commercial tissue adhesive containing FIBRINOGEN and THROMBIN. The commercial product is a two component system from human plasma that contains more than fibrinogen and thrombin. The first component contains highly concentrated fibrinogen, FACTOR VIII, fibronectin, and traces of other plasma proteins. The second component contains thrombin, calcium chloride, and antifibrinolytic agents such as APROTININ. Mixing of the two components promotes BLOOD CLOTTING and the formation and cross-linking of fibrin. The tissue adhesive is used for tissue sealing, HEMOSTASIS, and WOUND HEALING.
A type of oropharyngeal airway that provides an alternative to endotracheal intubation and standard mask anesthesia in certain patients. It is introduced into the hypopharynx to form a seal around the larynx thus permitting spontaneous or positive pressure ventilation without penetration of the larynx or esophagus. It is used in place of a facemask in routine anesthesia. The advantages over standard mask anesthesia are better airway control, minimal anesthetic gas leakage, a secure airway during patient transport to the recovery area, and minimal postoperative problems.
The application of a vacuum across the surface of a wound through a foam dressing cut to fit the wound. This removes wound exudates, reduces build-up of inflammatory mediators, and increases the flow of nutrients to the wound thus promoting healing.
In a clinical trial or interventional study, participants receive specific interventions according to the research plan or protocol created by the investigators. These interventions may be medical products, such as drugs or devices; procedures; or change...
Antiretroviral Therapy Clostridium Difficile Ebola HIV & AIDS Infectious Diseases Influenza Malaria Measles Sepsis Swine Flu Tropical Medicine Tuberculosis Infectious diseases are caused by pathogenic...