Vascular Access DevicesNCT04086693
Peripheral Intravenous Catheter Securement With Tissue Adhesive
A study testing Standard IV dressing and Standard IV dressing plus a tissue adhesive peripheral IV securement device in people with Vascular Access Devices, run by Corewell Health East at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Vascular Access Devices
- What is being tested?
- Standard IV dressing and Standard IV dressing plus a tissue adhesive peripheral IV securement device
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 350 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Sep 2019to 10 Oct 2020
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Peripheral Intravenous Catheter Securement With Tissue Adhesive Compared to Conventional Dressing: A Randomized Controlled Trial
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.
Read the 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.
- Conditions
- Vascular Access Devices
- Being tested
- Standard IV dressing, Standard IV dressing plus a tissue adhesive peripheral IV securement device
- Keywords
- intravenous access, vascular access, IV survival, IV catheter complication
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard IV dressingDevice
Polyurethane and clear tape dressing used to secure peripheral IV
Standard IV dressing plus a tissue adhesive peripheral IV securement deviceDevice
Also called Adhezion SecurePortIV
Polyurethane dressing with clear tape plus a tissue adhesive peripheral IV securement device used to secure peripheral IV
| Study group | Role | What they receive |
|---|---|---|
| Standard IV dressing | Active comparator | Polyurethane dressing with clear tape Receives: 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). Receives: Device: Standard IV dressing plus a tissue adhesive peripheral IV securement device |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 7 days or discharge, whichever occurs sooner
Secondary outcomes (2)
Mean Catheter Survival Duration
Mean catheter survival duration in days
Measured: 7 days or until discharge, whichever occurs sooner
Cause-specific IV Failure
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
Measured: 7 days or until discharge, whichever occurs sooner
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2019
- Study start16 Sep 2019
- Primary completion10 Oct 2020
- Study completion10 Oct 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Vascular Access DevicesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized controlled, parallel assignment
- Masking
- None (open label)
- Enrolment
- 350 participants (actual)
Sponsor and investigators
- Lead sponsor
- Corewell Health East
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amit Bahl, Corewell Health East
- Investigators
- Amit Bahl, MD, Principal investigator, Corewell Health East
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04086693
- Sponsor's protocol ID
- 2019-188
- Status last verified
- Dec 2021
- First submitted
- 9 Sep 2019
- Last updated
- 6 Dec 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Peripheral Intravenous Catheter Securement With Tissue Adhesive Compared to Conventional Dressing: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04086693
- Acronym / sponsor ID
- 2019-188
- Conditions
- Vascular Access Devices
- Keywords
- intravenous access, vascular access, IV survival, IV catheter complication
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 350 participants (actual)
- Lead sponsor
- Corewell Health EastUniversity, hospital or other
- Study start
- 16 Sep 2019 (actual)
- Primary completion
- 10 Oct 2020 (actual)
- Study completion
- 10 Oct 2020 (actual)
- First posted
- 12 Sep 2019 (actual)
- Results
- Posted 1 Feb 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized controlled, parallel assignment
| Arm | Type | Receives |
|---|---|---|
| Standard IV dressing | Active comparator | Device: Standard IV dressingPolyurethane dressing with clear tape |
| Standard IV dressing plus Adhezion SecurePortIV | Experimental | Device: Standard IV dressing plus a tissue adhesive peripheral IV securement devicePolyurethane dressing with clear tape plus Adhezion Biomedical SecurePortIV (a tissue adhesive peripheral IV securement device). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Standard IV dressingPolyurethane and clear tape dressing used to secure peripheral IV | Device | Standard IV dressing |
| Standard IV dressing plus a tissue adhesive peripheral IV securement deviceAlso: Adhezion SecurePortIVPolyurethane dressing with clear tape plus a tissue adhesive peripheral IV securement device used to secure peripheral IV | Device | Standard IV dressing plus Adhezion SecurePortIV |
Primary outcome
IV Catheter Survival
Time frame: 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.
2 secondary outcomes
Mean Catheter Survival Duration
Time frame: 7 days or until discharge, whichever occurs sooner
Cause-specific IV Failure
Time frame: 7 days or until discharge, whichever occurs sooner
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Dec 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Amit Bahl, MD principal investigator
Corewell Health East
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Standard IV dressing and Standard IV dressing plus a tissue adhesive peripheral IV securement device in people with Vascular Access Devices, run by Corewell Health East at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 1 Feb 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
IV Catheter Survival (time frame: 7 days or discharge, whichever occurs sooner). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Dec 2021.