A Multi-Center, Prospective, Randomized Trial Comparing the Peripheral I.V. Catheter Complication Rates of Two Different Catheter Dressings
Trial Snapshot
- Phase
- Not Applicable
- Status
- Terminated
- Sponsor
- Solventum US LLC
- Enrollment
- 247
- Locations
- 5
- Primary Endpoint
- Dressing Wear Time
Study Overview
Brief Summary
A multi-center randomized control trial comparing the dressing wear times of two different transparent film dressings when used to secure peripheral intravenous catheters of hospitalized adult patients.
Detailed Description
A multi-center, prospective, randomized control trial comparing the dressing wear time, complication rates and cost of two different transparent film dressing when used as intended for peripheral intravenous catheter site protection and securement in five U.S. hospitals.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •At least 18 years of age, or of consenting age;
- •Admitted or going to be admitted to the hospital;
- •Requires peripheral IV therapy (catheter) for an anticipated 72 hours or longer;
- •Has an insertion site in the forearm or hand free of phlebitis, infiltration, dermatitis, burns, lesions or tattoos;
- •Demonstrates cooperation with a catheter insertion and the securement protocol; and
- •Patient or legally authorized representative is willing and able to provide written informed consent and authorization for use and disclosure of Protected Health Information
Exclusion Criteria
- •Is a current participant or a past participant in this study;
- •If the subject already has a functioning PIV in place, not requiring a replacement catheter
- •If the study PIV catheter site will be placed below an old infusion site;
- •If the study PIV site needs to be immobilized with a splint or other device;
- •Has a documented or a known allergy or sensitivity to a medical adhesive product such as transparent film adhesive dressings, tapes, or liquid skin protectants;
- •Requires the application of a gauze pad, a topical ointment or solution under the dressing in addition to the prep(s) required in the protocol;
- •Will require a power injection through the study PIV catheter for a radiologic procedure during participation in this study;
- •Will require a numbing agent prior to PIV insertion; or
- •Will require the use of ultrasound for the PIV catheter insertion.
Arms & Interventions
New PIV Dressing
Bordered, notched dressing that covers, secures peripheral intravenous (PIV) catheter
Intervention: New PIV Dressing (Device)
Standard PIV Dressing
Film,adhesive dressing that covers, secures peripheral intravenous (PIV) catheter and used with a medical grade tape
Intervention: Standard PIV Dressing (Device)
Outcomes
Primary Outcomes
Dressing Wear Time
Time Frame: Dressing wear time was assessed daily and 8 month dressing wear data are presented
Dressing wear time is the time from dressing application to removal, i.e. catheter no longer needed or catheter-related complication occurs (remove dressing and catheter) OR excessive dressing lift requiring dressing replacement.
Secondary Outcomes
No secondary outcomes reported