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

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

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.

Study Overview

• Status: Terminated
• Conditions: Surgery
• Intervention / Treatment: Device: New PIV Dressing; Device: Standard PIV Dressing

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 Type: Interventional
• Enrollment (Actual): 247
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Nebraska
    • Omaha, Nebraska, United States, 68198-4031
      • University of Nebraska Medical Center
  • North Carolina
    • Chapel Hill, North Carolina, United States, 27599
      • University of North Carolina
  • Ohio
    • Cleveland, Ohio, United States, 44109
      • MetroHealth Medical Center
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15212
      • Allegheny General Hospital
  • Virginia
    • Richmond, Virginia, United States, 23298
      • Virginia Commonwealth University Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / 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.
Other: 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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Solventum US LLC
• Collaborators: 3M
• Investigators: Principal Investigator: Mark E Rupp, MD, University of Nebraska

Publications and helpful links

General Publications

• Wood D. A comparative study of two securement techniques for short peripheral intravenous catheters. J Intraven Nurs. 1997 Nov-Dec;20(6):280-5.
• 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.
• Sheppard K, LeDesma M, Morris NL, O'Connor K. A prospective study of two intravenous catheter securement techniques in a skilled nursing facility. J Intraven Nurs. 1999 May-Jun;22(3):151-6.
• Rosenthal K. Get a hold on costs and safety with securement devices. Nurs Manage. 2005 May;36(5):52-4. doi: 10.1097/00006247-200505000-00014.
• Schears GJ. Summary of product trials for 10, 164 patients: comparing an intravenous stabilizing device to tape. J Infus Nurs. 2006 Jul-Aug;29(4):225-31. doi: 10.1097/00129804-200607000-00009. Erratum In: J Infus Nurs. 2006 Sep-Oct;29(5):242.
• Bausone-Gazda D, LeFaiver C., et al. A randomized controlled trial to compare the complications of 2 peripheral intravenous catheter stabilization systems. J Intraven Nurs 33(6) Nov 2010 371-384.
• Dunnett CW, Gent M. An alternative to the use of two-sided tests in clinical trials. Stat Med. 1996 Aug 30;15(16):1729-38. doi: 10.1002/(SICI)1097-0258(19960830)15:163.0.CO;2-M.
• Hwang IK, Morikawa T. Design issues in noninferiority/equivalence trials. Drug Information journal 33: 1205-18, 1999.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start: September 1, 2014
• Primary Completion (Actual): May 1, 2015
• Study Completion (Actual): May 1, 2015

Study Registration Dates

• First Submitted: January 15, 2015
• First Submitted That Met QC Criteria: March 29, 2016
• First Posted (Estimated): April 1, 2016

Study Record Updates

• Last Update Posted (Actual): October 24, 2024
• Last Update Submitted That Met QC Criteria: September 30, 2024
• Last Verified: September 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: EM-05-013243

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Not required based on FDAA requirements