Trial Outcomes & Findings for Trial Comparing Peripheral I.V. Catheter Complication Rates of Two Different Catheter Dressings (NCT NCT02725788)
NCT ID: NCT02725788
Last Updated: 2024-10-24
Results Overview
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.
TERMINATED
NA
247 participants
Dressing wear time was assessed daily and 8 month dressing wear data are presented
2024-10-24
Participant Flow
From September 24, 2014 to May 12, 2015 at five U.S. hospitals
Participant milestones
| Measure |
New Dressing
Bordered, notched film dressing sized to cover, secure peripheral venous (PIV) catheters
|
Standard PIV Dressing
Film adhesive dressing used with medical grade tape and sized to cover, secure peripheral (PIV) catheters
|
|---|---|---|
|
Overall Study
STARTED
|
123
|
124
|
|
Overall Study
COMPLETED
|
122
|
122
|
|
Overall Study
NOT COMPLETED
|
1
|
2
|
Reasons for withdrawal
| Measure |
New Dressing
Bordered, notched film dressing sized to cover, secure peripheral venous (PIV) catheters
|
Standard PIV Dressing
Film adhesive dressing used with medical grade tape and sized to cover, secure peripheral (PIV) catheters
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
1
|
1
|
|
Overall Study
Protocol Violation
|
0
|
1
|
Baseline Characteristics
Trial Comparing Peripheral I.V. Catheter Complication Rates of Two Different Catheter Dressings
Baseline characteristics by cohort
| Measure |
New Dressing
n=122 Participants
Bordered, notched film dressing sized to cover, secure peripheral venous (PIV) catheters
|
Standard PIV Dressing
n=122 Participants
Film adhesive dressing used with medical grade tape and sized to cover, secure peripheral (PIV) catheters
|
Total
n=244 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
77 Participants
n=99 Participants
|
78 Participants
n=107 Participants
|
155 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
45 Participants
n=99 Participants
|
44 Participants
n=107 Participants
|
89 Participants
n=206 Participants
|
|
Age, Continuous
|
60 years
n=99 Participants
|
60 years
n=107 Participants
|
60 years
n=206 Participants
|
|
Sex: Female, Male
Female
|
60 Participants
n=99 Participants
|
58 Participants
n=107 Participants
|
118 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
62 Participants
n=99 Participants
|
64 Participants
n=107 Participants
|
126 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
122 participants
n=99 Participants
|
122 participants
n=107 Participants
|
244 participants
n=206 Participants
|
|
PIV catheter insertion location
Hand
|
74 Participants
n=99 Participants
|
71 Participants
n=107 Participants
|
145 Participants
n=206 Participants
|
|
PIV catheter insertion location
Lower Forearm
|
22 Participants
n=99 Participants
|
20 Participants
n=107 Participants
|
42 Participants
n=206 Participants
|
|
PIV catheter insertion location
Mid Forearm
|
16 Participants
n=99 Participants
|
15 Participants
n=107 Participants
|
31 Participants
n=206 Participants
|
|
PIV catheter insertion location
Upper Forearm
|
10 Participants
n=99 Participants
|
16 Participants
n=107 Participants
|
26 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Dressing wear time was assessed daily and 8 month dressing wear data are presentedPopulation: All subjects randomized except three subjects who either failed to have a study dressing applied or whom could not have the primary endpoint ascertained.
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.
Outcome measures
| Measure |
New Dressing
n=122 Participants
Bordered, notched film dressing sized to cover, secure peripheral venous (PIV) catheters
|
Standard PIV Dressing
n=122 Participants
Film adhesive dressing used with medical grade tape and sized to cover, secure peripheral (PIV) catheters
|
|---|---|---|
|
Dressing Wear Time
|
2.1 Days
Interval 0.0 to 7.0
|
2.1 Days
Interval 0.0 to 7.7
|
Adverse Events
New Dressing
Standard PIV Dressing
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place