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

NCT02725788 | Terminated Results

• 1 other identifier: EM-05-013243
• Study Type: interventional
• Target: 247
• Locations: 1 country
• Sites: 5

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.

Conditions

Surgery

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

New PIV Dressing

EXPERIMENTAL

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

Device: New PIV Dressing

Standard PIV Dressing

OTHER

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

Device: Standard PIV Dressing

Interventions

New PIV Dressing DEVICE

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.

New PIV Dressing

Standard PIV Dressing DEVICE

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.

Standard PIV Dressing

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Solventum US LLC: lead
• 3M: collaborator

Study Sites (5)

University of Nebraska Medical Center

Omaha, Nebraska, 68198-4031, United States

Location

University of North Carolina

Chapel Hill, North Carolina, 27599, United States

Location

MetroHealth Medical Center

Cleveland, Ohio, 44109, United States

Location

Allegheny General Hospital

Pittsburgh, Pennsylvania, 15212, United States

Location

Virginia Commonwealth University Medical Center

Richmond, Virginia, 23298, United States

Location

Related Publications (11)

• Wood D. A comparative study of two securement techniques for short peripheral intravenous catheters. J Intraven Nurs. 1997 Nov-Dec;20(6):280-5.

  PMID: 9423389 BACKGROUND

• Alexander M. Corrigan A. Infusion Nurses Society: Infusion nursing an evidence-based approach. St. Louis, Mo.: Saunders-Elsevier; 2010.

  BACKGROUND

• 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.

  BACKGROUND

• 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.

  PMID: 10640079 BACKGROUND

• 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.

  PMID: 15879998 BACKGROUND

• 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.

  PMID: 16858255 BACKGROUND

• Bausone-Gazda D, Lefaiver CA, Walters SA. A randomized controlled trial to compare the complications of 2 peripheral intravenous catheter-stabilization systems. J Infus Nurs. 2010 Nov-Dec;33(6):371-84. doi: 10.1097/NAN.0b013e3181f85be2.

  PMID: 21079465 BACKGROUND

• 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.

  PMID: 8870155 BACKGROUND

• Hwang IK, Morikawa T. Design issues in noninferiority/equivalence trials. Drug Information journal 33: 1205-18, 1999.

  BACKGROUND

• 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.

  PMID: 18496062 BACKGROUND

• 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.

  PMID: 9283675 BACKGROUND

Results Point of Contact

• Title: Laura Rutledge
• Organization: 3M

lfrutledge1@mmm.com

651-733-5394

Study Officials

• Mark E Rupp, MD

  University of Nebraska

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 15, 2015
• First Posted: April 1, 2016
• Study Start: September 1, 2014
• Primary Completion: May 1, 2015
• Study Completion: May 1, 2015
• Last Updated: October 24, 2024
• Results First Posted: April 24, 2017

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (5)