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Peripheral Intravenous Catheter Securement With Tissue Adhesive

NCT04086693 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 350

Last updated 2021-12-06

Study results available
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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

Interventions

DEVICE

Standard IV dressing

Polyurethane and clear tape dressing used to secure peripheral IV

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

Sponsors & Collaborators

  • William Beaumont Hospitals

    lead OTHER

Principal Investigators

  • Amit Bahl, MD · William Beaumont Hospitals

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-09-16
Primary Completion
2020-10-10
Completion
2020-10-10
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04086693 on ClinicalTrials.gov