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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.

Recruitment status

TERMINATED

Study phase

NA

Target enrollment

247 participants

Primary outcome timeframe

Dressing wear time was assessed daily and 8 month dressing wear data are presented

Results posted on

2024-10-24

Participant Flow

From September 24, 2014 to May 12, 2015 at five U.S. hospitals

Participant milestones

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

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

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=93 Participants
0 Participants
n=4 Participants
0 Participants
n=27 Participants
Age, Categorical
Between 18 and 65 years
77 Participants
n=93 Participants
78 Participants
n=4 Participants
155 Participants
n=27 Participants
Age, Categorical
>=65 years
45 Participants
n=93 Participants
44 Participants
n=4 Participants
89 Participants
n=27 Participants
Age, Continuous
60 years
n=93 Participants
60 years
n=4 Participants
60 years
n=27 Participants
Sex: Female, Male
Female
60 Participants
n=93 Participants
58 Participants
n=4 Participants
118 Participants
n=27 Participants
Sex: Female, Male
Male
62 Participants
n=93 Participants
64 Participants
n=4 Participants
126 Participants
n=27 Participants
Region of Enrollment
United States
122 participants
n=93 Participants
122 participants
n=4 Participants
244 participants
n=27 Participants
PIV catheter insertion location
Hand
74 Participants
n=93 Participants
71 Participants
n=4 Participants
145 Participants
n=27 Participants
PIV catheter insertion location
Lower Forearm
22 Participants
n=93 Participants
20 Participants
n=4 Participants
42 Participants
n=27 Participants
PIV catheter insertion location
Mid Forearm
16 Participants
n=93 Participants
15 Participants
n=4 Participants
31 Participants
n=27 Participants
PIV catheter insertion location
Upper Forearm
10 Participants
n=93 Participants
16 Participants
n=4 Participants
26 Participants
n=27 Participants

PRIMARY outcome

Timeframe: 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.

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

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

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Standard PIV Dressing

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Laura Rutledge

3M

Phone: 651-733-5394

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place