Peripheral Intravenous Catheter Securement With Tissue Adhesive

NCT04086693 | Completed Results FDA Device

• 1 other identifier: 2019-188
• Study Type: interventional
• Target: 350
• Locations: 1 country
• Sites: 1

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.

Conditions

Vascular Access Devices

Keywords

intravenous access; vascular access; IV survival; IV catheter complication

Outcome Measures

Primary Outcomes (1)

• IV Catheter Survival

  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.

  7 days or discharge, whichever occurs sooner

Secondary Outcomes (2)

• Mean Catheter Survival Duration

  7 days or until discharge, whichever occurs sooner

• Cause-specific IV Failure

  7 days or until discharge, whichever occurs sooner

Study Arms (2)

Standard IV dressing

ACTIVE COMPARATOR

Polyurethane dressing with clear tape

Device: Standard IV dressing

Standard IV dressing plus Adhezion SecurePortIV

EXPERIMENTAL

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

Interventions

Standard IV dressing DEVICE

Polyurethane and clear tape dressing used to secure peripheral IV

Standard IV dressing

Standard IV dressing plus a tissue adhesive peripheral IV securement device DEVICE

Polyurethane dressing with clear tape plus a tissue adhesive peripheral IV securement device used to secure peripheral IV

Also known as: Adhezion SecurePortIV

Standard IV dressing plus Adhezion SecurePortIV

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Greater or equal to 18 years of age
• 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
• IV placement in the antecubital fossa, forearm, wrist or hand
• IV placement in the ED
• Enrollment within 8 hours of IV insertion
• or 20 gauge 1.16 inch IV catheter
• Expected hospital admission \>48 hours

You may not qualify if:

• Patients with ultrasound-guided IV insertions
• Alternate site of cannulation
• Voluntary withdrawal
• Patients with a non-standard polyurethane dressing
• Known allergy to cyanoacrylate or formaldehyde

Sponsors & Collaborators

• Corewell Health East: lead

Study Sites (1)

Beaumont Health System

Royal Oak, Michigan, 48073, United States

Location

Results Point of Contact

• Title: Amit Bahl, MD
• Organization: Beaumont Health

Amit.Bahl@beaumont.edu

248-551-1792

Study Officials

• Amit Bahl, MD

  Corewell Health East

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director Emergency Medicine Ultrasound

Model Details: Randomized controlled, parallel assignment

Study Record Dates

• First Submitted: September 9, 2019
• First Posted: September 12, 2019
• Study Start: September 16, 2019
• Primary Completion: October 10, 2020
• Study Completion: October 10, 2020
• Last Updated: December 6, 2021
• Results First Posted: February 1, 2021

Record last verified: 2021-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)