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

Study Overview
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Brief Summary
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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
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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.

Official Title
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A Multi-Center, Prospective, Randomized Trial Comparing the Peripheral I.V. Catheter Complication Rates of Two Different Catheter Dressings

Conditions
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Surgery

Intervention / Treatment
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* Device: New PIV Dressing
* Device: Standard PIV Dressing


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: New PIV Dressing<br>Bordered, notched dressing that covers, secures peripheral intravenous (PIV) catheter | Device: New PIV Dressing<br>* A commercially available breathable, transparent film dressing with a soft-cloth border, notch and securement tape strip. The dressing system is used in the study to cover a peripheral intravenous catheter insertion site and secure the catheter. Dressing system is to remain in place until the PIV catheter is discontinued which is anticipated to be 72 hours. The dressing and PIV site will be observed daily. If dressing excessively lifts from the skin, the dressing system will be replaced with the same, assigned dressing system. The number of dressing replacements and the duration of wear will be measured while the same study PIV catheter dwells, an average of 72 hours during the subject's hospitalization.<br>|
| Other: Standard PIV Dressing<br>Film,adhesive dressing that covers, secures peripheral intravenous (PIV) catheter and used with a medical grade tape | Device: Standard PIV Dressing<br>* A commercially available breathable, transparent film dressing used with a one inch width piece of Transpore™ medical tape. The dressing system is used in the study to cover a peripheral intravenous catheter insertion site and secure the catheter. Dressing system is to remain in place until catheter is discontinued which is anticipated to be 72 hours. The dressing and PIV site will be observed daily. If dressing excessively lifts from the skin, the dressing system will be replaced with the same, assigned dressing system. The number of dressing replacements and the duration of wear will be measured while the same study PIV catheter dwells, an average of 72 hours during the subject's hospitalization.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Dressing Wear Time | 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. | Dressing wear time was assessed daily and 8 month dressing wear data are presented |