Trial Comparing Peripheral I.V. Catheter Complication Rates of Two Different Catheter Dressings

Solventum US LLC

Status: Terminated

Conditions: Surgery

Treatments: Device: New PIV Dressing; Device: Standard PIV Dressing

Study type: Interventional

Funder types: Industry

Identifiers

NCT02725788

EM-05-013243

Details and patient eligibility

About

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.

Full 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.

Enrollment: 247 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. At least 18 years of age, or of consenting age;
2. Admitted or going to be admitted to the hospital;
3. Requires peripheral IV therapy (catheter) for an anticipated 72 hours or longer;
4. Has an insertion site in the forearm or hand free of phlebitis, infiltration, dermatitis, burns, lesions or tattoos;
5. Demonstrates cooperation with a catheter insertion and the securement protocol; and
6. 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

1. Is a current participant or a past participant in this study;
2. If the subject already has a functioning PIV in place, not requiring a replacement catheter
3. If the study PIV catheter site will be placed below an old infusion site;
4. If the study PIV site needs to be immobilized with a splint or other device;
5. 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;
6. 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;
7. Will require a power injection through the study PIV catheter for a radiologic procedure during participation in this study;
8. Will require a numbing agent prior to PIV insertion; or
9. Will require the use of ultrasound for the PIV catheter insertion.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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247 participants in 2 patient groups

New PIV Dressing

Experimental group

Description:

Bordered, notched dressing that covers, secures peripheral intravenous (PIV) catheter

Treatment:

Device: New PIV Dressing

Standard PIV Dressing

Other group

Description:

Film,adhesive dressing that covers, secures peripheral intravenous (PIV) catheter and used with a medical grade tape

Treatment:

Device: Standard PIV Dressing