Pain, Phlebitis, Skin and Subcutaneous Tissue Disorders, Vascular Access Complication
Conditions
Keywords
Catheters, Vascular Access Devices, Catheter-Related Infections, Nurse Specialists, Nurses, Randomised Controlled Trial
Brief summary
Study in which a zinc oxide fixation device (a product that can help protect the skin) for catheters (polyurethane tubes inserted into a vein) will be tested to reduce catheter-related complications: catheter displacement, skin complications, phlebitis and pain..
Detailed description
Introduction: Midline catheters (MLC) and peripherally inserted central catheters (PICC) are commonly used vascular access devices (VAD) in healthcare institutions where infusion therapies are required, and have been proven to have an optimal level of safety and efficacy for intravenous drug delivery. However, the insertion of these VADs has a number of potential associated complications (immediate, early and/or late), and proper fixation may reduce them. Hypothesis: Using a zinc oxide adhesive securement device (ASD) reduces the number of fixation-associated complications in MLC and PICC compared to a universal ASD with silicone adhesive. Objective: To evaluate the efficacy of using a ASD with zinc oxide for post insertion fixation of MLC and PICC in hospitalised adult patients. Methodology: Randomised clinical study. Two randomised groups will be created before catheter cannulation. The control group will be cured with an ASD with acrylic adhesive (Grip-Lok® Ref.3300MWA) and the intervention group will be cured with ASD with zinc oxide (Grip-Lok® Ref.2200NUZA). Expected results: The investigators expect to reduce the number of complications related to the attachment of PICCs and MLCs in adult hospitalised patients following the protocolised placement of a ASD with zinc oxide during the first cure. Specifically, it is expected to reduce the number of catheter dislodgements, the number of medical adhesive-related skin injuries (MARSI) and the amount of phlebitis. Clinical implication: The study will help to improve decision making related to maintenance and care of VAD in order to reduce the main associated complications.
Interventions
PROCEDUREControl group: acrylic adhesive sutureless fixation device
The standard care consists of: * Application of hemostasis at the point of insertion for 2 minutes post puncture or until bleeding stops. * Fix with clear polyurethane dressing (3M®-1655 Tegaderm™ IV), cyanoacrylate glue (SecurePortIV®) and acrylic adhesive sutureless fixation device (3300MWA Grip-Lok®).
PROCEDUREIntervention Group: zinc oxide sutureless fixation device
Alternative care consisted of: * Application of haemostasis at the insertion site for 2 minutes post-puncture or until cessation of bleeding. * Fixation with clear polyurethane dressing (3M®-1655 Tegaderm™ IV), cyanoacrylate glue (SecurePortIV®) and zinc oxide sutureless fixation device (2200NUZA Grip-Lok®).
DEVICEPICC
The PICC lines used in the study will all be third-generation polyurethane and of the commercial brands: * PowerPICC™ 4, 5 and 6 Fr from BD * Maxflo expert™ 5 and 6 Fr from Vygon
DEVICEMidline
The midline lines used in the study will be second or third generation polyurethane and of the commercial brands: * PowerMidline™ 4 Fr from BD * Arrow® Midline 4Fr from Arrow
OTHERUltrasound scanner
All punctures will be performed under ultrasound guidance.
Sponsors
Hospital Arnau de Vilanova
Official College of Nurses of Lleida
Department of Health, Generalitat de Catalunya (PERIS)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Outcomes Assessor)
Masking description
The researchers are the ones who performed the insertion of the catheters and the subsequent data collection, but the patients do not know which ones have the zinc oxide device and which ones do not. In addition, the results will be evaluated by a researcher external to the data collection.
Intervention model description
Classic parallel model with an intervention group, where the catheters will be fixed with a zinc oxide fixation dressing (Grip-Lok® Ref.2200NUZA), and a control group where the catheters will be fixed with a dressing without zinc oxide (acrylic adhesive) (Grip-Lok® Ref.3300MWA).
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* requiring cannulation of a midline catheter or a PICC * who accepted and signed the informed consent voluntarily * with an inpatient unit admission of minimum 7 days
Exclusion criteria
\- patients with a known allergy to zinc oxide
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of participants with treatment-related adverse events as assessed by CTCAE v5.0. | 7 days | Percentage of participants with adverse events following cannulation of a midline or peripherally inserted central catheter after fixation with a zinc oxide sutureless fixation device. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of participants with altered skin under the sutureless fixation device assessed by observation (yes/no). | 7 days | Percentage of participants with skin alterations under the sutureless fixation device after puncture of a midline or central venous catheter with the modified micro-Seldinger technique. Four examinations will be performed: post puncture, at 24 hours, at 72 hours and at 7 days, in which the puncture site will be visualized for signs of skin alterations and it will be noted whether they exist and what type (Hematoma, Skin Stripping, Tension Injury or Blister, Skin Tear, Irritant Contact Dermatitis, Allergic Contact Dermatitis, Maceration or Folliculitis). |
| Number of participants with post-treatment catheter displacement assessed by observation (yes/no). | 7 days | Percentage of participants with catheter displacement after puncture of a midline or central venous catheter with the modified micro-Seldinger technique. Four cures will be performed: post puncture, at 24 hours, 72 hours and 7 days, where the puncture site will be visualized to check if the catheter is still in the same point or if it has been displaced. |
| Number of participants with post-treatment phlebitis assessed with the Maddox visual phlebitis rating scale. | 7 days | Percentage of participants with phlebitis after puncture of a midline or central venous catheter with the modified micro-Seldinger technique. Four cures will be performed: post puncture, at 24 hours, 72 hours and 7 days, where the puncture site will be visualized to check for signs of phlebitis, according to the Maddox scale. |
| Number of participants with post-treatment pain in extremity assessed with the EVA scale. | 7 days | Percentage of participants with pain in extremity after puncture of a midline or central venous catheter with the modified micro-Seldinger technique. Four cures will be performed: post puncture, at 24 hours, 72 hours and 7 days, where the patient will be asked what pain he/she feels in the extremity related to the catheter. |
Countries
Spain
Contacts
CONTACTPadilla-Nula F PhD candidate, Nurse
Outcome results
None listed