Peripheral Intravenous Catheter StabilizationNCT04845906
A 7 Day Adhesive Device Wear Study to Evaluate BD StatLock™ Devices
An observational study of Peripheral Intravenous Catheter Stabilization, run by Becton, Dickinson and Company at 2 sites in United States.
Trial summary
This study is a prospective healthy human volunteer wear study to evaluate the safety and performance of the StatLock™ Catheter Stabilization Device and the StatLock™ stabilization device Accessory (Foam Strip) and to meet the design input requirements. Read more about this study
- Who is it for?
- Ages 14 years and olderHealthy volunteers can take part
- Conditions the study is for
- Peripheral Intravenous Catheter Stabilization
- What is being tested?
- StatLock™ Catheter Stabilization Device and the StatLock™ stabilization device accessory (Foam Strip)
- Type of treatment
- Injection or infusion, Medical device
- How many people
- 120 participants
- Where
- 2 sitesUnited States
- Study dates
- 13 Jul 2021to 23 Aug 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
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 14 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Potential participants will be recruited from healthy volunteer participant pools identified and/or held by the study site(s).
Who may be able to join
- Any healthy human, 14 years of age or older, regardless of gender (Note: Consent of guardian or parent may be required for patients who are under 18 years of age).
- If they provide written and informed consent.
- Expected to be available for observation from consent, to the application on Day 0, and then removal of the StatLock™ Catheter Stabilization Device on Day 7, and for a follow up phone and/or video call on Day 8 for a skin assessment.
- Participant agrees to maintain a diary from device application, Day 0, through device removal, Day 7.
- Agree to keep the StatLock™ Catheter Stabilization Device, ancillary products, and site dry throughout the study
- Agrees to not use moisturizers, lotions, or any product labeled moisturizing for the duration of the study, at or around the site where the devices will be applied (inner (ventral) forearm).
Who cannot join
- If their skin was burned or scarred at the insertion site, or has any other skin condition which may affect the adherence and/or interpretation of the study results.
- If they have a known allergy to the study products (known tape or adhesive allergy).
- Has a medical condition which may prevent him or her from completing the study or place the study participant at undue risk.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Dermico, LLC
Broomall, Pennsylvania, 19008
TKL Research, Inc
Fair Lawn, New Jersey, 07410
About this study
This study is a prospective healthy human volunteer wear study to evaluate the safety and performance of the StatLock™ Catheter Stabilization Device and the StatLock™ stabilization device Accessory (Foam Strip) and to meet the design input requirements.
Read the detailed description
This is a healthy human wear study of a minimum of 100 study participants who will wear the StatLock™ Catheter Stabilization Device and the StatLock™ stabilization device accessory (Foam Strip). Participants will report to the research center, on Day 0 to have their skin assessed by the investigator, clinician, and/or designee. On Day 0 the participants will have the StatLock™ Catheter Stabilization Devices and the foam strip applied. There will be 4 separate StatLock™ devices being tested, which will be randomly applied to the participants on their inner (ventral) forearms. Each participant will have 2 separate devices applied, one to each arm. Those participants who have the StatLock ™ Arterial Plus, StatLock™ Dialysis II, or the StatLock IV Select , will also have the Foam Strip applied.
The participant will also wear a dressing over top of a StatLock™ compatible catheter, which will be connected to an extension set. For this study, the catheter will not be inserted into the study participant but instead will be shortened or modified and placed on the skin and secured with the StatLock™ Stabilization Device. The catheter tip will be marked with indelible ink, to assess for any catheter movement. The use of the catheters, extension set, and the dressing represents how the device would be used in a clinical setting.
Once the devices are applied the participant will have the skin assessed (using a modified Draize Scale) by the investigator, clinician, and/or designee on Day 0. The participant will wear the devices at home for 1 week and will return on Day 7 for a skin assessment, evaluation of pad and foam strip lift, and catheter movement, evaluation of pain, and removal of the devices by the investigator, clinician, and/or designee. On Day 8, there may be a phone call and/or video call with the participant to review the skin condition of the site where the device was removed from.
- Being tested
- StatLock™ Catheter Stabilization Device and the StatLock™ stabilization device accessory (Foam Strip)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
StatLock™ Catheter Stabilization Device and the StatLock™ stabilization device accessory (Foam Strip)Device
Also called StatLock™ Pro- SLP001, StatLock™ IV Select- IV0521CE, StatLock™ Arterial Plus- ART0222CE, StatLock™ Dialysis II- VDS2
Each participant will have 2 separate devices applied, one to each arm, with or without a Foam Strip.The participant will also wear a dressing over top of a StatLock™ compatible catheter, which will be connected to an extension set. For this study, the catheter will not be inserted into the study participant but instead will be shortened or modified and placed on the skin and secured with the StatLock™ Stabilization Device. The use of the catheters, extension set, and the dressing represents how the device would be used in a clinical setting.
| Study group | Role | What they receive |
|---|---|---|
| Healthy volunteers | There will be 4 separate StatLock™ devices being tested, which will be randomly applied to the participants on their inner (ventral) forearms. Each participant will have 2 separate devices applied, one to each arm. Those participants who have the StatLock ™ Arterial Plus, StatLock™ Dialysis II, or the StatLock IV Select, will also have the foam strip applied. Receives: Device: StatLock™ Catheter Stabilization Device and the StatLock™ stabilization device accessory (Foam Strip) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent lift of the StatLock™ Catheter Stabilization Device Pad at Day 7
Device pad lift will be assessed using a Visual Analog Scale, ranging from 0 - Fully adhered to 100 - Device absent. When the percent lift at day 7 is >50%, it is considered a failure.
Measured: Day 7
Percent of Device Movement of the StatLock™ Catheter Stabilization Device at Day 7
The percent of device movement of the catheter will be assessed using a Visual Analog Scale from 0 (no movement) to 100 (completely displaced).
Measured: Day 7
Ease of Removal of the StatLock™ Catheter Stabilization Device
Ease of removal will be assessed using a 100 mm Visual Analog Scale where 0 is very easy to remove and 100 is very difficult to remove.
Measured: Day 7
Percent of participants with erythema score ≥ 2
Erythema score will be assessed using a modified Draize scale with scores ranging from 0 to 3, as follows: 0 - no visible reaction; 0.5 - Doubtful or negligible erythema reaction; 1.0 - mild or just perceptible macular erythema reaction in a speckled/follicular, patchy or confluent pattern (slight pinking); 2.0 - Moderate erythema reaction in a confluent pattern (definite redness); 3 - Strong or brisk erythema reaction that may spread beyond the test site).
Measured: Day 7
Secondary outcomes (3)
Percent lift of the Foam Strip (StatLock™ Stabilization Device Accessory) at Day 7
The percent lift of the foam strip will be assessed using a Visual Analog Scale ranging from 0 (fully adhered) to 100 (device accessory absent).
Measured: Day 7
Ease of Removal of the StatLock™ Stabilization Device Foam Strip
The ease of removal will be assessed using a 100 mm Visual Analog Scale where 0 is very easy to remove and 100 is very difficult to remove.
Measured: Day 7
Level of pain upon removal of the StatLock™ Catheter Stabilization Device
Pain upon removal of the device will be assessed using a 100 mm Visual Analog Scale where 0 is no pain and 100 is unbearable pain.
Measured: Day 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2021
- Study start13 Jul 2021
- Primary completion23 Aug 2021
- Study completion23 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peripheral Intravenous Catheter StabilizationStudies 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Becton, Dickinson and Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Michael Casser, MD, Principal investigator, TKL Research, Inc.Gary Grove, PhD, Principal investigator, Dermico, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04845906
- Sponsor's protocol ID
- MDS-21STLOCK001
- Status last verified
- Sep 2021
- First submitted
- 9 Apr 2021
- Last updated
- 8 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A 7 Day Adhesive Device Wear Study to Evaluate BD StatLock™ Devices
- ClinicalTrials.gov ID
- NCT04845906
- Acronym / sponsor ID
- MDS-21STLOCK001
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Becton, Dickinson and CompanyIndustry (pharma, biotech, devices)
- Study start
- 13 Jul 2021 (actual)
- Primary completion
- 23 Aug 2021 (actual)
- Study completion
- 23 Aug 2021 (actual)
- First posted
- 15 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is a prospective healthy human volunteer wear study to evaluate the safety and performance of the StatLock™ Catheter Stabilization Device and the StatLock™ stabilization device Accessory (Foam Strip) and to meet the design input requirements.
Detailed description
This is a healthy human wear study of a minimum of 100 study participants who will wear the StatLock™ Catheter Stabilization Device and the StatLock™ stabilization device accessory (Foam Strip). Participants will report to the research center, on Day 0 to have their skin assessed by the investigator, clinician, and/or designee. On Day 0 the participants will have the StatLock™ Catheter Stabilization Devices and the foam strip applied. There will be 4 separate StatLock™ devices being tested, which will be randomly applied to the participants on their inner (ventral) forearms. Each participant will have 2 separate devices applied, one to each arm. Those participants who have the StatLock ™ Arterial Plus, StatLock™ Dialysis II, or the StatLock IV Select , will also have the Foam Strip applied.
The participant will also wear a dressing over top of a StatLock™ compatible catheter, which will be connected to an extension set. For this study, the catheter will not be inserted into the study participant but instead will be shortened or modified and placed on the skin and secured with the StatLock™ Stabilization Device. The catheter tip will be marked with indelible ink, to assess for any catheter movement. The use of the catheters, extension set, and the dressing represents how the device would be used in a clinical setting.
Once the devices are applied the participant will have the skin assessed (using a modified Draize Scale) by the investigator, clinician, and/or designee on Day 0. The participant will wear the devices at home for 1 week and will return on Day 7 for a skin assessment, evaluation of pad and foam strip lift, and catheter movement, evaluation of pain, and removal of the devices by the investigator, clinician, and/or designee. On Day 8, there may be a phone call and/or video call with the participant to review the skin condition of the site where the device was removed from.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Healthy volunteers | – | Device: StatLock™ Catheter Stabilization Device and the StatLock™ stabilization device accessory (Foam Strip)There will be 4 separate StatLock™ devices being tested, which will be randomly applied to the participants on their inner (ventral) forearms. Each participant will have 2 separate devices applied, one to each arm. Those participants who have the StatLock ™ Arterial Plus, StatLock™ Dialysis II, or the StatLock IV Select, will also have the foam strip applied. |
Who may qualify
- Ages
- 14 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Potential participants will be recruited from healthy volunteer participant pools identified and/or held by the study site(s).
Key inclusion criteria (6 listed)
- Any healthy human, 14 years of age or older, regardless of gender (Note: Consent of guardian or parent may be required for patients who are under 18 years of age).
- If they provide written and informed consent.
- Expected to be available for observation from consent, to the application on Day 0, and then removal of the StatLock™ Catheter Stabilization Device on Day 7, and for a follow up phone and/or video call on Day 8 for a skin assessment.
- Participant agrees to maintain a diary from device application, Day 0, through device removal, Day 7.
- Agree to keep the StatLock™ Catheter Stabilization Device, ancillary products, and site dry throughout the study
Key exclusion criteria (3 listed)
- If their skin was burned or scarred at the insertion site, or has any other skin condition which may affect the adherence and/or interpretation of the study results.
- If they have a known allergy to the study products (known tape or adhesive allergy).
- Has a medical condition which may prevent him or her from completing the study or place the study participant at undue risk.
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 |
|---|---|---|
| StatLock™ Catheter Stabilization Device and the StatLock™ stabilization device accessory (Foam Strip)Also: StatLock™ Pro- SLP001, StatLock™ IV Select- IV0521CE, StatLock™ Arterial Plus- ART0222CE, StatLock™ Dialysis II- VDS2Each participant will have 2 separate devices applied, one to each arm, with or without a Foam Strip.The participant will also wear a dressing over top of a StatLock™ compatible catheter, which will be connected to an extension set. For this study, the catheter will not be inserted into the study participant but instead will be shortened or modified and placed on the skin and secured with the StatLock™ Stabilization Device. The use of the catheters, extension set, and the dressing represents how the device would be used in a clinical setting. | Device | Healthy volunteers |
Primary outcome
Percent lift of the StatLock™ Catheter Stabilization Device Pad at Day 7
Time frame: Day 7
Device pad lift will be assessed using a Visual Analog Scale, ranging from 0 - Fully adhered to 100 - Device absent. When the percent lift at day 7 is >50%, it is considered a failure.
Percent of Device Movement of the StatLock™ Catheter Stabilization Device at Day 7
Time frame: Day 7
The percent of device movement of the catheter will be assessed using a Visual Analog Scale from 0 (no movement) to 100 (completely displaced).
Ease of Removal of the StatLock™ Catheter Stabilization Device
Time frame: Day 7
Ease of removal will be assessed using a 100 mm Visual Analog Scale where 0 is very easy to remove and 100 is very difficult to remove.
Percent of participants with erythema score ≥ 2
Time frame: Day 7
Erythema score will be assessed using a modified Draize scale with scores ranging from 0 to 3, as follows: 0 - no visible reaction; 0.5 - Doubtful or negligible erythema reaction; 1.0 - mild or just perceptible macular erythema reaction in a speckled/follicular, patchy or confluent pattern (slight pinking); 2.0 - Moderate erythema reaction in a confluent pattern (definite redness); 3 - Strong or brisk erythema reaction that may spread beyond the test site).
3 secondary outcomes
Percent lift of the Foam Strip (StatLock™ Stabilization Device Accessory) at Day 7
Time frame: Day 7
Ease of Removal of the StatLock™ Stabilization Device Foam Strip
Time frame: Day 7
Level of pain upon removal of the StatLock™ Catheter Stabilization Device
Time frame: Day 7
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2021.
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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.
Michael Casser, MD principal investigator
TKL Research, Inc.
Gary Grove, PhD principal investigator
Dermico, LLC
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Peripheral Intravenous Catheter Stabilization, run by Becton, Dickinson and Company at 2 sites 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 6 inclusion and 3 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 8 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Percent lift of the StatLock™ Catheter Stabilization Device Pad at Day 7 (time frame: Day 7). The study lists 4 primary outcomes in all. 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 8 Sep 2021.