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

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ClinicalTrials.gov Identifier: NCT02725788
Recruitment Status : Terminated (Due to futility)
First Posted : April 1, 2016
Results First Posted : April 24, 2017
Last Update Posted : May 30, 2017
Sponsor:
Information provided by (Responsible Party):
3M

Study Description
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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.

Condition or disease Intervention/treatment Phase
Surgery Device: New PIV Dressing Device: Standard PIV Dressing Not Applicable

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
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 247 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Multi-Center, Prospective, Randomized Trial Comparing the Peripheral I.V. Catheter Complication Rates of Two Different Catheter Dressings
Study Start Date : September 2014
Actual Primary Completion Date : May 2015
Actual Study Completion Date : May 2015
Arms and Interventions
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Arm Intervention/treatment
Experimental: New PIV Dressing
Bordered, notched dressing that covers, secures peripheral intravenous (PIV) catheter
 Device: New PIV Dressing
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.
Standard PIV Dressing
Film,adhesive dressing that covers, secures peripheral intravenous (PIV) catheter and used with a medical grade tape
 Device: Standard PIV Dressing
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.


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02725788


Locations
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United States, Nebraska
University of Nebraska Medical Center
Omaha, Nebraska, United States, 68198-4031
United States, North Carolina
University of North Carolina
Chapel Hill, North Carolina, United States, 27599
United States, Ohio
MetroHealth Medical Center
Cleveland, Ohio, United States, 44109
United States, Pennsylvania
Allegheny General Hospital
Pittsburgh, Pennsylvania, United States, 15212
United States, Virginia
Virginia Commonwealth University Medical Center
Richmond, Virginia, United States, 23298
Sponsors and Collaborators
3M
Investigators
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Principal Investigator: Mark E Rupp, MD University of Nebraska
More Information
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Publications:
Alexander M. Corrigan A. Infusion Nurses Society: Infusion nursing an evidence-based approach. St. Louis, Mo.: Saunders-Elsevier; 2010.
Royer T. Improving short peripheral IV outcomes: a clinical trial of two securement methods. Journal of the Association for Vascular Access. 2003; 8(4): 45-49.
Hwang IK, Morikawa T. Design issues in noninferiority/equivalence trials. Drug Information journal 33: 1205-18, 1999.

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Responsible Party: 3M
ClinicalTrials.gov Identifier: NCT02725788    
Other Study ID Numbers: EM-05-013243
First Posted: April 1, 2016    Key Record Dates
Results First Posted: April 24, 2017
Last Update Posted: May 30, 2017
Last Verified: April 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Not required based on FDAA requirements