N/A
N=350
Peripheral Intravenous Catheter Securement With Tissue Adhesive
Vascular Access Devices
Bottom Line
View on ClinicalTrials.gov: NCT04086693 ↗Enrolled (actual)
350
Serious AEs
0.0%
Results posted
Feb 2021
Primary outcome: Primary: IV Catheter Survival — 66; 55 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Standard IV dressing (Device); Standard IV dressing plus a tissue adhesive peripheral IV securement device (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Corewell Health East
- Primary completion
- Oct 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY IV Catheter Survival |
66; 55 | — |
| SECONDARY Mean Catheter Survival Duration |
5.43; 5.97 | — |
| SECONDARY Cause-specific IV Failure |
23; 26; 13; 10; 8; 3 | — |
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.
Eligibility Criteria
Inclusion Criteria
- 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
- 18 or 20 gauge 1.16 inch IV catheter
- Expected hospital admission >48 hours
Exclusion Criteria
- 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
Data sourced from ClinicalTrials.gov (NCT04086693). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.