Surgery
Conditions
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.
Interventions
DEVICENew 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.
DEVICEStandard 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.
Sponsors
3M
Solventum US LLC
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Dressing Wear Time | 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. |
Countries
United States
Participant flow
Recruitment details
From September 24, 2014 to May 12, 2015 at five U.S. hospitals
Participants by arm
| Arm | Count |
|---|---|
| New Dressing Bordered, notched film dressing sized to cover, secure peripheral venous (PIV) catheters | 122 |
| Standard PIV Dressing Film adhesive dressing used with medical grade tape and sized to cover, secure peripheral (PIV) catheters | 122 |
| Total | 244 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 1 | 1 |
| Overall Study | Protocol Violation | 0 | 1 |
Baseline characteristics
| Characteristic | New Dressing | Standard PIV Dressing | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 45 Participants | 44 Participants | 89 Participants |
| Age, Categorical Between 18 and 65 years | 77 Participants | 78 Participants | 155 Participants |
| Age, Continuous | 60 years | 60 years | 60 years |
| PIV catheter insertion location Hand | 74 Participants | 71 Participants | 145 Participants |
| PIV catheter insertion location Lower Forearm | 22 Participants | 20 Participants | 42 Participants |
| PIV catheter insertion location Mid Forearm | 16 Participants | 15 Participants | 31 Participants |
| PIV catheter insertion location Upper Forearm | 10 Participants | 16 Participants | 26 Participants |
| Region of Enrollment United States | 122 participants | 122 participants | 244 participants |
| Sex: Female, Male Female | 60 Participants | 58 Participants | 118 Participants |
| Sex: Female, Male Male | 62 Participants | 64 Participants | 126 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 123 | 0 / 124 |
| serious Total, serious adverse events | 0 / 123 | 0 / 124 |
Outcome results
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.
Time frame: Dressing wear time was assessed daily and 8 month dressing wear data are presented
Population: All subjects randomized except three subjects who either failed to have a study dressing applied or whom could not have the primary endpoint ascertained.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| New Dressing | Dressing Wear Time | 2.1 Days |
| Standard PIV Dressing | Dressing Wear Time | 2.1 Days |