Trial Outcomes & Findings for Peripheral Intravenous Catheter Securement With Tissue Adhesive (NCT NCT04086693)

Results Overview

Number of participants with all-cause functional failure of the catheter. Failure is defined by loss of patency (resistance to flush with minimum 1-2 ml normal saline, or lack of blood return to tubing on aspiration) or presence of complications requiring removal (any level of pain or tenderness, changes in skin color (blanching or erythema), changes in skin temperature (hot or cold), edema, induration, leakage of fluid or purulent discharge from the puncture site, or other dysfunction). Function is assessed daily by research staff.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

350 participants

Primary outcome timeframe

7 days or discharge, whichever occurs sooner

Results posted on

2021-12-06

Participant Flow

350

Participant milestones

Participant milestones
Measure	Standard IV Dressing Polyurethane dressing with clear tape Standard IV dressing: Polyurethane and clear tape dressing used to secure peripheral IV	Standard IV Dressing Plus Adhezion SecurePortIV Polyurethane dressing with clear tape plus Adhezion Biomedical SecurePortIV (a tissue adhesive peripheral IV securement device). Standard IV dressing plus a tissue adhesive peripheral IV securement device: Polyurethane dressing with clear tape plus a tissue adhesive peripheral IV securement device used to secure peripheral IV
Overall Study STARTED	175	175
Overall Study COMPLETED	174	171
Overall Study NOT COMPLETED	1	4

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Standard IV Dressing Plus Adhezion SecurePortIV n=171 Participants Polyurethane dressing with clear tape plus Adhezion Biomedical SecurePortIV (a tissue adhesive peripheral IV securement device). Standard IV dressing plus a tissue adhesive peripheral IV securement device: Polyurethane dressing with clear tape plus a tissue adhesive peripheral IV securement device used to secure peripheral IV	Total n=345 Participants Total of all reporting groups	Standard IV Dressing n=174 Participants Polyurethane dressing with clear tape Standard IV dressing: Polyurethane and clear tape dressing used to secure peripheral IV
Age, Continuous	68.8 years STANDARD_DEVIATION 15.4 • n=171 Participants	68.4 years STANDARD_DEVIATION 15.3 • n=345 Participants	68.0 years STANDARD_DEVIATION 15.3 • n=174 Participants
Sex: Female, Male Female	73 Participants n=171 Participants	152 Participants n=345 Participants	79 Participants n=174 Participants
Sex: Female, Male Male	98 Participants n=171 Participants	193 Participants n=345 Participants	95 Participants n=174 Participants
Race and Ethnicity Not Collected	—	0 Participants Race and Ethnicity were not collected from any participant.	—

PRIMARY outcome

Timeframe: 7 days or discharge, whichever occurs sooner

Number of participants with all-cause functional failure of the catheter. Failure is defined by loss of patency (resistance to flush with minimum 1-2 ml normal saline, or lack of blood return to tubing on aspiration) or presence of complications requiring removal (any level of pain or tenderness, changes in skin color (blanching or erythema), changes in skin temperature (hot or cold), edema, induration, leakage of fluid or purulent discharge from the puncture site, or other dysfunction). Function is assessed daily by research staff.

Outcome measures

Outcome measures
Measure	Standard IV Dressing n=174 Participants Polyurethane dressing with clear tape Standard IV dressing: Polyurethane and clear tape dressing used to secure peripheral IV	Standard IV Dressing Plus Adhezion SecurePortIV n=171 Participants Polyurethane dressing with clear tape plus Adhezion Biomedical SecurePortIV (a tissue adhesive peripheral IV securement device). Standard IV dressing plus a tissue adhesive peripheral IV securement device: Polyurethane dressing with clear tape plus a tissue adhesive peripheral IV securement device used to secure peripheral IV
IV Catheter Survival	66 Participants	55 Participants

SECONDARY outcome

Timeframe: 7 days or until discharge, whichever occurs sooner

Population: Numbers of participants reflect those fulfilling 48 hour dwell per protocol

Mean catheter survival duration in days

Outcome measures

Outcome measures
Measure	Standard IV Dressing n=141 Participants Polyurethane dressing with clear tape Standard IV dressing: Polyurethane and clear tape dressing used to secure peripheral IV	Standard IV Dressing Plus Adhezion SecurePortIV n=142 Participants Polyurethane dressing with clear tape plus Adhezion Biomedical SecurePortIV (a tissue adhesive peripheral IV securement device). Standard IV dressing plus a tissue adhesive peripheral IV securement device: Polyurethane dressing with clear tape plus a tissue adhesive peripheral IV securement device used to secure peripheral IV
Mean Catheter Survival Duration	5.43 days Interval 0.0 to 7.0	5.97 days Interval 0.0 to 6.71

SECONDARY outcome

Timeframe: 7 days or until discharge, whichever occurs sooner

Number of participants with IV catheter failures by specific cause, including infiltration, phlebitis, dislodgment, leaking, infection, and occlusion. IV failure is assessed daily by research staff and by chart review, post patient discharge

Outcome measures

Outcome measures
Measure	Standard IV Dressing n=174 Participants Polyurethane dressing with clear tape Standard IV dressing: Polyurethane and clear tape dressing used to secure peripheral IV	Standard IV Dressing Plus Adhezion SecurePortIV n=171 Participants Polyurethane dressing with clear tape plus Adhezion Biomedical SecurePortIV (a tissue adhesive peripheral IV securement device). Standard IV dressing plus a tissue adhesive peripheral IV securement device: Polyurethane dressing with clear tape plus a tissue adhesive peripheral IV securement device used to secure peripheral IV
Cause-specific IV Failure Other	1 Participants	1 Participants
Cause-specific IV Failure Infiltration	23 Participants	26 Participants
Cause-specific IV Failure Phlebitis	13 Participants	10 Participants
Cause-specific IV Failure Dislodgement	8 Participants	3 Participants
Cause-specific IV Failure Leaking	31 Participants	24 Participants
Cause-specific IV Failure Occlusion	1 Participants	3 Participants
Cause-specific IV Failure Death of Participant	1 Participants	1 Participants
Cause-specific IV Failure Completion of Therapy	96 Participants	103 Participants

Adverse Events

Standard IV Dressing

Serious events: 0 serious events

Other events: 0 other events

Deaths: 1 deaths

Standard IV Dressing Plus Adhezion SecurePortIV

Serious events: 0 serious events

Other events: 0 other events

Deaths: 1 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Amit Bahl, MD

Beaumont Health

Phone: 248-551-1792

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place