Peripheral Intravenous Catheter Securement With Tissue Adhesive

• Sponsor: William Beaumont Hospitals (Other)
• Overall Status: Completed
• CT.gov ID: NCT04086693
• Collaborator: (none)
• Enrollment: 350
• Location: 1
• Arms: 2
• Actual Duration (Months): 12.8
• Patients Per Site Per Month: 27.3

Study Details

Study Description

Brief Summary

This clinical trial will compare survival of peripheral intravenous (IV) catheters for patients with a standard IV site dressing alone to patients with standard IV dressing plus Adhezion Biomedical SecurePortIV Catheter Securement Adhesive. Emergency room patients who already have IVs may be considered for inclusion. Eligible patients will be approached and, if they are interested in participating, their informed consent will be obtained.

Participation will continue for up to 7 days. During this time, the patient will experience:

• Assessment of their currently placed peripheral IV catheter, to assess if it is functioning

• Assignment to one of two study groups (standard IV dressing or standard IV dressing plus Adhezion Biomedical SecurePortIV Catheter Securement Adhesive). This is called randomization and group assignment is by chance, like the flip of a coin

• Daily assessment of the IV catheter and site for complications (such as infection or phlebitis), removal, and medications being administered.

Condition or Disease	Intervention/Treatment	Phase
Vascular Access Devices	Device: Standard IV dressing; Device: Standard IV dressing plus a tissue adhesive peripheral IV securement device	N/A

Detailed Description

Patients admitted from the Emergency Department (ED) to a progressive floor, or patients admitted from ED to any floor type with express approval from the Principal Investigator are eligible participants. Research staff will approach patients admitted to the progressive floors (or other floors when identified by PI) based on screening of the electronic medical record. These patients are approached by research staff when physically in the emergency department waiting for a room assignment. If the patient agrees to participate in the trial, the study subject will approached for consent by the research staff. Research staff will confirm functionality of the existing peripheral IV previously placed by ED staff. The assessment will include observing for blood return into the tubing upon aspiration and/or unobstructed flush with a minimum of 1-2 ml of normal saline. Staff will also observe the site for any signs of redness or tenderness. A tourniquet may be applied as needed. If the patient is actively receiving an infusion, the drip will briefly be halted to evaluate for functionality. Functionality will be assessed with the existing dressing in place. If the catheter is functional and free of any signs of complications, study subjects will be randomized by a computer generated 1:1 envelope system to either the control group: polyurethane dressing + clear tape or the experimental group: polyurethane dressing + clear tape + tissue adhesive. The tissue adhesive is not standard of care at Beaumont. For the control group, the polyurethane dressing will be gently removed. Dressing will be removed carefully to minimize any potential dislodgments or skin injury. The site will be evaluated for oozing or blood and as needed cleaned with sterile gauze. Once the site is completely dry, a new polyurethane dressing will be applied and reinforced with tape in a standard fashion. Once securement is complete, functionality will be reassessed per protocol above. For the experimental group, the existing securement will be gently removed. There are not special steps required for removing the dressing with the tissue adhesive. The IV catheter is secured and the dressing is removed gently. The site will be evaluated for oozing or blood and as needed cleaned with sterile gauze. Once the site is completely dry, the tissue adhesive will be applied. A new standard polyurethane dressing will be applied and tape will be applied per the standard approach. Once securement is complete, functionality will be reassessed. The time of the new dressing application will be noted as time zero. Catheter dwell time will begin at this point. Additional data variables collected at the initial assessment include: demographics such as age, sex, international normalized ratio (INR) >1.5, platelets < 50, insertion site details, hours from insertion to recruitment, inserter credentials.

Follow-up Assessment:

After initial assessment, the catheter will be assessed by the research team every 24 hours as long as the patient is hospitalized up to 7 days or 168 hours. At each follow up interval the researcher notes the date /time of evaluation and assesses for any signs and symptoms of complications and functionality of the device. A catheter is functional if the IV flushes without resistance. Complications include infiltration, phlebitis, dislodgement, oozing fluid/blood, purulent drainage, or occlusion. Catheters will be assessed daily for signs and symptoms of complications. Any signs or symptoms of complications or lack of functionality will be reported to the patient's primary care team so that management of the IV catheter can be addressed. If the catheter was identified to have any signs or symptoms of complications during follow-up assessment the date and time of observation of the complication will be documented in the data collection tool and the primary team will be notified of the complication. If the catheter was removed prior to the follow-up assessment then the IV removal time and the reason for removal will be obtained through chart review. For all catheters removed due to a complication, re-insertion attempt data will be tracked through the medical record in the nursing section for venous lines and need for reinsertion of the IV or escalation to a midline, peripherally inserted central catheter (PICC), or central venous catheter (CVC) will be noted. If the patient is discharged prior to the time of follow-up assessment then the time of discharge will be documented and the IV will be presumed functional until time of discharge unless otherwise noted in the chart.

The medication administration record will be queried for all medications given through each catheter with specific attention to antibiotics and anticoagulants. Vesicants/irritants that are generally given via central line or considered caustic to the vessel will be noted in both groups. Number of doses will be recorded. Additional data gathered by research staff on follow-up evaluation includes: dwell time in days/hours, hospital length of stay, and number of peripheral IVs for duration of stay.

Study Design

• Study Type: Interventional
• Actual Enrollment: 350 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: Randomized controlled, parallel assignmentRandomized controlled, parallel assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Peripheral Intravenous Catheter Securement With Tissue Adhesive Compared to Conventional Dressing: A Randomized Controlled Trial
• Actual Study Start Date: Sep 16, 2019
• Actual Primary Completion Date: Oct 10, 2020
• Actual Study Completion Date: Oct 10, 2020

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Standard IV dressing Polyurethane dressing with clear tape	Device: Standard IV dressing; Polyurethane and clear tape dressing used to secure peripheral IV
Experimental: Standard IV dressing plus Adhezion SecurePortIV Polyurethane dressing with clear tape plus Adhezion Biomedical SecurePortIV (a tissue adhesive peripheral IV securement device).	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; Other Names: Adhezion SecurePortIV

Outcome Measures

Primary Outcome Measures

1. IV Catheter Survival [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.

Secondary Outcome Measures

1. Mean Catheter Survival Duration [7 days or until discharge, whichever occurs sooner]

   Mean catheter survival duration in days

2. Cause-specific IV Failure [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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

1. Greater or equal to 18 years of age

2. Admission from the Emergency Department (ED) to a progressive floor, or Admission from ED to any floor type with express approval from the Principal Investigator

3. IV placement in the antecubital fossa, forearm, wrist or hand

4. IV placement in the ED

5. Enrollment within 8 hours of IV insertion

6. 18 or 20 gauge 1.16 inch IV catheter

7. Expected hospital admission >48 hours

Exclusion Criteria:

1. Patients with ultrasound-guided IV insertions

2. Alternate site of cannulation

3. Voluntary withdrawal

4. Patients with a non-standard polyurethane dressing

5. Known allergy to cyanoacrylate or formaldehyde

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Beaumont Health System	Royal Oak	Michigan	United States	48073

Sponsors and Collaborators

• William Beaumont Hospitals

Investigators

• Principal Investigator: Amit Bahl, MD, William Beaumont Hospitals

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Jun 16, 2020

More Information

Publications

None provided.

• Responsible Party: Amit Bahl, Director Emergency Medicine Ultrasound, William Beaumont Hospitals
• ClinicalTrials.gov Identifier: NCT04086693
• Other Study ID Numbers: 2019-188
• First Posted: Sep 12, 2019
• Last Update Posted: Dec 6, 2021
• Last Verified: Dec 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Product Manufactured in and Exported from the U.S.: Yes
• Keywords provided by Amit Bahl, Director Emergency Medicine Ultrasound, William Beaumont Hospitals: intravenous access; vascular access; IV survival; IV catheter complication

Study Results

Participant Flow

Recruitment Details	350

Arm/Group Title	Standard IV Dressing	Standard IV Dressing Plus Adhezion SecurePortIV
Arm/Group Description	Polyurethane dressing with clear tape Standard IV dressing: Polyurethane and clear tape dressing used to secure peripheral IV	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
Period Title: Overall Study
STARTED	175	175
COMPLETED	174	171
NOT COMPLETED	1	4

Baseline Characteristics

Arm/Group Title	Standard IV Dressing	Standard IV Dressing Plus Adhezion SecurePortIV	Total
Arm/Group Description	Polyurethane dressing with clear tape Standard IV dressing: Polyurethane and clear tape dressing used to secure peripheral IV	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 of all reporting groups
Overall Participants	174	171	345
Age (years) [Median (Standard Deviation) ]
Median (Standard Deviation) [years]	68.0 (15.3)	68.8 (15.4)	68.4 (15.3)
Sex: Female, Male (Count of Participants)
Female	79 45.4%	73 42.7%	152 44.1%
Male	95 54.6%	98 57.3%	193 55.9%
Race and Ethnicity Not Collected (Count of Participants)
Count of Participants [Participants]	0 0%

Outcome Measures

1. Primary Outcome

Title	IV Catheter Survival
Description	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.
Time Frame	7 days or discharge, whichever occurs sooner

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Standard IV Dressing	Standard IV Dressing Plus Adhezion SecurePortIV
Arm/Group Description	Polyurethane dressing with clear tape Standard IV dressing: Polyurethane and clear tape dressing used to secure peripheral IV	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
Measure Participants	174	171
Count of Participants [Participants]	66 37.9%	55 32.2%

2. Secondary Outcome

Title	Mean Catheter Survival Duration
Description	Mean catheter survival duration in days
Time Frame	7 days or until discharge, whichever occurs sooner

Outcome Measure Data

Analysis Population Description

Numbers of participants reflect those fulfilling 48 hour dwell per protocol

Arm/Group Title	Standard IV Dressing	Standard IV Dressing Plus Adhezion SecurePortIV
Arm/Group Description	Polyurethane dressing with clear tape Standard IV dressing: Polyurethane and clear tape dressing used to secure peripheral IV	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
Measure Participants	141	142
Mean (Full Range) [days]	5.43	5.97

3. Secondary Outcome

Title	Cause-specific IV Failure
Description	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
Time Frame	7 days or until discharge, whichever occurs sooner

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Standard IV Dressing	Standard IV Dressing Plus Adhezion SecurePortIV
Arm/Group Description	Polyurethane dressing with clear tape Standard IV dressing: Polyurethane and clear tape dressing used to secure peripheral IV	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
Measure Participants	174	171
Infiltration	23 13.2%	26 15.2%
Phlebitis	13 7.5%	10 5.8%
Dislodgement	8 4.6%	3 1.8%
Leaking	31 17.8%	24 14%
Occlusion	1 0.6%	3 1.8%
Death of Participant	1 0.6%	1 0.6%
Other	1 0.6%	1 0.6%
Completion of Therapy	96 55.2%	103 60.2%

Adverse Events

Time Frame	Adverse event data was collected on each patient from IV insertion until IV removal for a maximum of 7 days.
Arm/Group Title	Standard IV Dressing		Standard IV Dressing Plus Adhezion SecurePortIV
Arm/Group Description	Polyurethane dressing with clear tape Standard IV dressing: Polyurethane and clear tape dressing used to secure peripheral IV		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
All Cause Mortality
	Standard IV Dressing		Standard IV Dressing Plus Adhezion SecurePortIV
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	1/174 (0.6%)		1/171 (0.6%)
Serious Adverse Events
	Standard IV Dressing		Standard IV Dressing Plus Adhezion SecurePortIV
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/174 (0%)		0/171 (0%)
Other (Not Including Serious) Adverse Events
	Standard IV Dressing		Standard IV Dressing Plus Adhezion SecurePortIV
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/174 (0%)		0/171 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.