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Due to futility
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| Name | Class |
|---|---|
| 3M | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| New PIV Dressing | Experimental | Bordered, notched dressing that covers, secures peripheral intravenous (PIV) catheter |
|
| Standard PIV Dressing | Other | Film,adhesive dressing that covers, secures peripheral intravenous (PIV) catheter and used with a medical grade tape |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mark E Rupp, MD | University of Nebraska | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Nebraska Medical Center | Omaha | Nebraska | 68198-4031 | United States | ||
| University of North Carolina |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 9423389 | Background | Wood D. A comparative study of two securement techniques for short peripheral intravenous catheters. J Intraven Nurs. 1997 Nov-Dec;20(6):280-5. | |
| 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. | ||
| 10640079 |
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Not required based on FDAA requirements
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From September 24, 2014 to May 12, 2015 at five U.S. hospitals
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| ID | Title | Description |
|---|---|---|
| FG000 | New Dressing | Bordered, notched film dressing sized to cover, secure peripheral venous (PIV) catheters |
| FG001 | Standard PIV Dressing | Film adhesive dressing used with medical grade tape and sized to cover, secure peripheral (PIV) catheters |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
All subjects randomized except 3 subjects who either failed to have the study dressing applied or whom the primary endpoint could not be ascertained
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| ID | Title | Description |
|---|---|---|
| BG000 | New Dressing | Bordered, notched film dressing sized to cover, secure peripheral venous (PIV) catheters |
| BG001 | Standard PIV Dressing | Film adhesive dressing used with medical grade tape and sized to cover, secure peripheral (PIV) catheters |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | All subjects randomized except three subjects who either failed to have a study dressing applied or whom could not have the primary endpoint ascertained. | Posted | Median | Full Range | Days | Dressing wear time was assessed daily and 8 month dressing wear data are presented |
|
8 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | New Dressing | Bordered, notched film dressing sized to cover, secure peripheral venous (PIV) catheters |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Laura Rutledge | 3M | 651-733-5394 | lfrutledge1@mmm.com |
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|
| 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. |
|
| Chapel Hill |
| North Carolina |
| 27599 |
| United States |
| MetroHealth Medical Center | Cleveland | Ohio | 44109 | United States |
| Allegheny General Hospital | Pittsburgh | Pennsylvania | 15212 | United States |
| Virginia Commonwealth University Medical Center | Richmond | Virginia | 23298 | United States |
| 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. |
| 15879998 | 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. |
| 16858255 | 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. |
| 21079465 | 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. |
| 8870155 | 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. |
| Background | Hwang IK, Morikawa T. Design issues in noninferiority/equivalence trials. Drug Information journal 33: 1205-18, 1999. |
| 18496062 | 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. |
| 9283675 | 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. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Median | Full Range | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| PIV catheter insertion location | Count of Participants | Participants |
|
Film adhesive dressing used with medical grade tape and sized to cover, secure peripheral (PIV) catheters
|
|
| 0 |
| 123 |
| 0 |
| 123 |
| EG001 | Standard PIV Dressing | Film adhesive dressing used with medical grade tape and sized to cover, secure peripheral (PIV) catheters | 0 | 124 | 0 | 124 |
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