Clinical trial NCT02725788: Trial Comparing Peripheral I.V. Catheter Complication Rates of Two Different Catheter Dressings
Official title: A Multi-Center, Prospective, Randomized Trial Comparing the Peripheral I.V. Catheter Complication Rates of Two Different Catheter Dressings
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Surgery
Lead sponsor: Solventum US LLC
Sponsor class: INDUSTRY
Collaborators: name: 3M
First posted: 2016-04-01
Enrollment: 247
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Dressing Wear Time
timeFrame: Dressing wear time was assessed daily and 8 month dressing wear data are presented
Secondary outcomes:
Other outcomes:
Locations:
city: Omaha
country: United States
facility: University of Nebraska Medical Center
state: Nebraska
city: Chapel Hill
country: United States
facility: University of North Carolina
state: North Carolina
city: Cleveland
country: United States
facility: MetroHealth Medical Center
state: Ohio
city: Pittsburgh
country: United States
facility: Allegheny General Hospital
state: Pennsylvania
city: Richmond
country: United States
facility: Virginia Commonwealth University Medical Center
state: Virginia
Study officials:
affiliation: University of Nebraska
name: Mark E Rupp, MD
role: PRINCIPAL_INVESTIGATOR
References:
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citation: Tripathi S, Kaushik V, Singh V. Peripheral IVs: factors affecting complications and patency--a randomized controlled trial. J Infus Nurs. 2008 May-Jun;31(3):182-8. doi: 10.1097/01.NAN.0000317704.03415.b9.
citation: Tripepi-Bova KA, Woods KD, Loach MC. A comparison of transparent polyurethane and dry gauze dressings for peripheral i.v. catheter sites: rates of phlebitis, infiltration, and dislodgment by patients. Am J Crit Care. 1997 Sep;6(5):377-81.