Central Venous Catheter Exit Site InfectionNCT04462861
A New Securement Method for External Tunneled Central Venous Access Devices (CVAD)
A study testing Central venous access device (CVAD) Snuggie Securement Device in people with Central Venous Catheter Exit Site Infection and Central Venous Catheter Related Bloodstream Infection, run by University of Colorado, Denver at 1 site in United States.
Trial summary
An external tunneled central venous access device (CVAD) is a small plastic tube that is tunneled under the skin into a major vein for long-term use (Figure 1). Patients who require a tunneled CVAD are some of the sickest patients we encounter and include oncology, hematology, and gastrointestinal (intestinal failure)… Read more about this study
- Who is it for?
- Ages 31 days to 18 years
- Conditions the study is for
- Central Venous Catheter Exit Site Infection, Central Venous Catheter Related Bloodstream Infection
- What is being tested?
- Central venous access device (CVAD) Snuggie Securement Device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Oct 2020to Jun 2024
- Phase
- Interventional
- 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 31 days to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Patients aged 31 days to 18 years old, who will undergo surgical placement of a tunneled CVAD
- Any patient with a pre-existing CVAD, who presents to the surgery clinic, emergency department, or is seen as an inpatient consult relating to complications associated with their CVAD
- Patients admitted to the hospital with a pre-existing CVAD for reasons unrelated to the CVAD will be eligible for the study
Who cannot join
- Any assenting child or consenting parent/guardian can at any time refuse to participate in the study and will be removed
- Any patient whose parents or legal guardians cannot be reached in person or by telephone to provide consent
- Any prisoners, pregnant women, or person with impaired decision-making capacity
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Children's Hospital Colorado
Aurora, Colorado, 54008
Marina Reppucci, MD, 203-731-4914
About this study
An external tunneled central venous access device (CVAD) is a small plastic tube that is tunneled under the skin into a major vein for long-term use (Figure 1). Patients who require a tunneled CVAD are some of the sickest patients we encounter and include oncology, hematology, and gastrointestinal (intestinal failure) patients. These patients are heavily reliant on their tunneled CVAD, which can be a lifeline for long-term administration of chemotherapeutics, IV medications, blood product transfusions, antibiotics, enteral nutrition, blood draws and fluids. Unfortunately, nearly 30% of pediatric external tunneled CVADs fail prior to the completion of treatment. External tunneled CVAD failures lead to unnecessary morbidity and mortality, interruption of medical therapy, and the added costs and risks associated with additional procedural complications. It is hypothesized that a newly designed securement method for external tunneled central venous access devices (CVAD) will reduce catheter-related complications and increase patient, parent and provider satisfaction, compared to the current standard of care, which is a clear transparent film dressing over the catheter exit site. A 20 patient, prospective clinical trial is proposed to address the following specific aims, which will determine if the securement device:
- Is rated by patients, parents and providers as easy to apply and comfortable for users
- Reduces CVAD-related complications, such as delayed healing of the tract, catheter-related infections, and episodes of catheter dislodgement
- Improves the quality of life for patients and their parents
- Is preferred over the standard, clear transparent dressing alone
- Requires any design modifications to improve performance and/or comfort of the device
Read the detailed description
A prospective pilot trial to examine the feasibility for a new CVAD securement device prototype (see appendix for computer-aided design drawings). Eligible patients will be identified by either mid-level providers, consulting services, or attending surgeons. Researchers will obtain consent from the patient or their parent/legal guardian. Caregivers will be educated on how to apply the securement device and will be given a number to call should they have any questions or concerns. Once the patient is enrolled and provided with the device, the investigators will perform follow up telephone interviews at one and three weeks to evaluate their experience and ensure they did not experience any adverse events.
The investigators will prospectively record the primary and secondary outcomes regarding use of the securement device, including: comfort, quality of materials, adhesive, ease of use, skin problems, infections, dislodgement episodes, catheter breakage, types and numbers of interactions with healthcare providers (phone calls, emergency department and clinic visits), perceived safety, and overall impressions.
- Conditions
- Central Venous Catheter Exit Site Infection, Central Venous Catheter Related Bloodstream Infection
- Being tested
- Central venous access device (CVAD) Snuggie Securement Device
- Keywords
- central venous access device, CVAD
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Central venous access device (CVAD) Snuggie Securement DeviceDevice
Participants will be given a prototype of a CVAD securement device for a three week trial. Descriptive data relating to user satisfaction will be collected at 1 and 3 weeks
| Study group | Role | What they receive |
|---|---|---|
| CVAD securement device | Experimental | Patients with a pre-existing CVAD who will trial the new securement dressing Receives: Device: Central venous access device (CVAD) Snuggie Securement Device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comfort
Survey question asking for qualitative description of satisfaction
Measured: 3 weeks
quality of materials
Survey question asking for qualitative description of satisfaction
Measured: 3 weeks
Quality of Adhesive
Survey question asking for qualitative description of satisfaction
Measured: 3 weeks
Ease of use
Survey question asking for qualitative description of satisfaction
Measured: 3 weeks
Skin irritation
Survey question asking for qualitative description of complication, if applicable
Measured: 3 weeks
Infection
Survey question asking for qualitative description of complication, if applicable
Measured: 3 weeks
dislodgement
Survey question asking for qualitative description of complication, if applicable
Measured: 3 weeks
catheter breakage
Survey question asking for qualitative description of complication, if applicable
Measured: 3 weeks
types and numbers of interactions with healthcare providers
Survey question asking for qualitative description of interaction, if applicable
Measured: 3 weeks
Perceived safety
Survey question asking for qualitative description of perceived device safety
Measured: 3 weeks
overall impression
Survey question asking for qualitative description of overall impression of device
Measured: 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2020
- Study start19 Oct 2020
- Primary completionJun 2024 (estimated)
- Study completionJun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Central Venous Catheter Exit Site InfectionStudies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe sponsor's other registered studies.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Collaborators
- Children's Hospital Colorado
- Responsible party
- Sponsor
- Investigators
- Steven L Moulton, MD, Principal investigator, Children's Hospital Colorado
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04462861
- Sponsor's protocol ID
- 20-1592
- Status last verified
- Jun 2023
- First submitted
- 24 Jun 2020
- Last updated
- 15 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is no plan to make individual participant data available to other researchers
Publications
Ullman AJ, Marsh N, Mihala G, Cooke M, Rickard CM. Complications of Central Venous Access Devices: A Systematic Review. Pediatrics. 2015 Nov;136(5):e1331-44. doi: 10.1542/peds.2015-1507. Epub 2015 Oct 12.
PubMed 26459655Ullman AJ, Cooke M, Rickard C. Examining the role of securement and dressing products to prevent central venous access device failure: a narrative review J Assoc Vasc Access 2015; 20:99-110
Frey AM, Schears GJ. Why are we stuck on tape and suture? A review of catheter securement devices. J Infus Nurs. 2006 Jan-Feb;29(1):34-8. doi: 10.1097/00129804-200601000-00007.
PubMed 16428999Orgel E, Ji L, Pastor W, Schore RJ. Infectious morbidity by catheter type in neutropenic children with cancer. Pediatr Infect Dis J. 2014 Mar;33(3):263-6. doi: 10.1097/INF.0000000000000060.
PubMed 24263218Brandt B, DePalma J, Irwin M, Shogan J, Lucke JF. Comparison of central venous catheter dressings in bone marrow transplant recipients. Oncol Nurs Forum. 1996 Jun;23(5):829-36.
PubMed 8792352Shivnan JC, McGuire D, Freedman S, Sharkazy E, Bosserman G, Larson E, Grouleff P. A comparison of transparent adherent and dry sterile gauze dressings for long-term central catheters in patients undergoing bone marrow transplant. Oncol Nurs Forum. 1991 Nov-Dec;18(8):1349-56.
PubMed 1762975Chambers ST, Sanders J, Patton WN, Ganly P, Birch M, Crump JA, Spearing RL. Reduction of exit-site infections of tunnelled intravascular catheters among neutropenic patients by sustained-release chlorhexidine dressings: results from a prospective randomized controlled trial. J Hosp Infect. 2005 Sep;61(1):53-61. doi: 10.1016/j.jhin.2005.01.023.
PubMed 16002181Ruschulte H, Franke M, Gastmeier P, Zenz S, Mahr KH, Buchholz S, Hertenstein B, Hecker H, Piepenbrock S. Prevention of central venous catheter related infections with chlorhexidine gluconate impregnated wound dressings: a randomized controlled trial. Ann Hematol. 2009 Mar;88(3):267-72. doi: 10.1007/s00277-008-0568-7. Epub 2008 Aug 5.
PubMed 18679683Ullman AJ, Kleidon T, Gibson V, McBride CA, Mihala G, Cooke M, Rickard CM. Innovative dressing and securement of tunneled central venous access devices in pediatrics: a pilot randomized controlled trial. BMC Cancer. 2017 Aug 30;17(1):595. doi: 10.1186/s12885-017-3606-9.
PubMed 28854967
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A New Securement Method for External Tunneled Central Venous Access Devices (CVAD)
- ClinicalTrials.gov ID
- NCT04462861
- Acronym / sponsor ID
- 20-1592
- Conditions
- Central Venous Catheter Exit Site Infection, Central Venous Catheter Related Bloodstream Infection
- Keywords
- central venous access device, CVAD
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Collaborators
- Children's Hospital Colorado
- Study start
- 19 Oct 2020 (actual)
- Primary completion
- Jun 2024 (estimated)
- Study completion
- Jun 2024 (estimated)
- First posted
- 8 Jul 2020 (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.
An external tunneled central venous access device (CVAD) is a small plastic tube that is tunneled under the skin into a major vein for long-term use (Figure 1). Patients who require a tunneled CVAD are some of the sickest patients we encounter and include oncology, hematology, and gastrointestinal (intestinal failure) patients. These patients are heavily reliant on their tunneled CVAD, which can be a lifeline for long-term administration of chemotherapeutics, IV medications, blood product transfusions, antibiotics, enteral nutrition, blood draws and fluids. Unfortunately, nearly 30% of pediatric external tunneled CVADs fail prior to the completion of treatment. External tunneled CVAD failures lead to unnecessary morbidity and mortality, interruption of medical therapy, and the added costs and risks associated with additional procedural complications. It is hypothesized that a newly designed securement method for external tunneled central venous access devices (CVAD) will reduce catheter-related complications and increase patient, parent and provider satisfaction, compared to the current standard of care, which is a clear transparent film dressing over the catheter exit site. A 20 patient, prospective clinical trial is proposed to address the following specific aims, which will determine if the securement device:
- Is rated by patients, parents and providers as easy to apply and comfortable for users
- Reduces CVAD-related complications, such as delayed healing of the tract, catheter-related infections, and episodes of catheter dislodgement
- Improves the quality of life for patients and their parents
- Is preferred over the standard, clear transparent dressing alone
- Requires any design modifications to improve performance and/or comfort of the device
Detailed description
A prospective pilot trial to examine the feasibility for a new CVAD securement device prototype (see appendix for computer-aided design drawings). Eligible patients will be identified by either mid-level providers, consulting services, or attending surgeons. Researchers will obtain consent from the patient or their parent/legal guardian. Caregivers will be educated on how to apply the securement device and will be given a number to call should they have any questions or concerns. Once the patient is enrolled and provided with the device, the investigators will perform follow up telephone interviews at one and three weeks to evaluate their experience and ensure they did not experience any adverse events.
The investigators will prospectively record the primary and secondary outcomes regarding use of the securement device, including: comfort, quality of materials, adhesive, ease of use, skin problems, infections, dislodgement episodes, catheter breakage, types and numbers of interactions with healthcare providers (phone calls, emergency department and clinic visits), perceived safety, and overall impressions.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CVAD securement device | Experimental | Device: Central venous access device (CVAD) Snuggie Securement DevicePatients with a pre-existing CVAD who will trial the new securement dressing |
Who may qualify
- Ages
- 31 days to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Patients aged 31 days to 18 years old, who will undergo surgical placement of a tunneled CVAD
- Any patient with a pre-existing CVAD, who presents to the surgery clinic, emergency department, or is seen as an inpatient consult relating to complications associated with their CVAD
- Patients admitted to the hospital with a pre-existing CVAD for reasons unrelated to the CVAD will be eligible for the study
Key exclusion criteria (3 listed)
- Any assenting child or consenting parent/guardian can at any time refuse to participate in the study and will be removed
- Any patient whose parents or legal guardians cannot be reached in person or by telephone to provide consent
- Any prisoners, pregnant women, or person with impaired decision-making capacity
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 |
|---|---|---|
| Central venous access device (CVAD) Snuggie Securement DeviceParticipants will be given a prototype of a CVAD securement device for a three week trial. Descriptive data relating to user satisfaction will be collected at 1 and 3 weeks | Device | CVAD securement device |
Primary outcome
Comfort
Time frame: 3 weeks
Survey question asking for qualitative description of satisfaction
quality of materials
Time frame: 3 weeks
Survey question asking for qualitative description of satisfaction
Quality of Adhesive
Time frame: 3 weeks
Survey question asking for qualitative description of satisfaction
Ease of use
Time frame: 3 weeks
Survey question asking for qualitative description of satisfaction
Skin irritation
Time frame: 3 weeks
Survey question asking for qualitative description of complication, if applicable
Infection
Time frame: 3 weeks
Survey question asking for qualitative description of complication, if applicable
dislodgement
Time frame: 3 weeks
Survey question asking for qualitative description of complication, if applicable
catheter breakage
Time frame: 3 weeks
Survey question asking for qualitative description of complication, if applicable
types and numbers of interactions with healthcare providers
Time frame: 3 weeks
Survey question asking for qualitative description of interaction, if applicable
Perceived safety
Time frame: 3 weeks
Survey question asking for qualitative description of perceived device safety
overall impression
Time frame: 3 weeks
Survey question asking for qualitative description of overall impression of device
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2023.
- Background: PubMed 26459655Ullman AJ, Marsh N, Mihala G, Cooke M, Rickard CM. Complications of Central Venous Access Devices: A Systematic Review. Pediatrics. 2015 Nov;136(5):e1331-44. doi: 10.1542/peds.2015-1507. Epub 2015 Oct 12.
- BackgroundUllman AJ, Cooke M, Rickard C. Examining the role of securement and dressing products to prevent central venous access device failure: a narrative review J Assoc Vasc Access 2015; 20:99-110
- Background: PubMed 16428999Frey AM, Schears GJ. Why are we stuck on tape and suture? A review of catheter securement devices. J Infus Nurs. 2006 Jan-Feb;29(1):34-8. doi: 10.1097/00129804-200601000-00007.
- Background: PubMed 24263218Orgel E, Ji L, Pastor W, Schore RJ. Infectious morbidity by catheter type in neutropenic children with cancer. Pediatr Infect Dis J. 2014 Mar;33(3):263-6. doi: 10.1097/INF.0000000000000060.
- Background: PubMed 8792352Brandt B, DePalma J, Irwin M, Shogan J, Lucke JF. Comparison of central venous catheter dressings in bone marrow transplant recipients. Oncol Nurs Forum. 1996 Jun;23(5):829-36.
- Background: PubMed 1762975Shivnan JC, McGuire D, Freedman S, Sharkazy E, Bosserman G, Larson E, Grouleff P. A comparison of transparent adherent and dry sterile gauze dressings for long-term central catheters in patients undergoing bone marrow transplant. Oncol Nurs Forum. 1991 Nov-Dec;18(8):1349-56.
- Background: PubMed 16002181Chambers ST, Sanders J, Patton WN, Ganly P, Birch M, Crump JA, Spearing RL. Reduction of exit-site infections of tunnelled intravascular catheters among neutropenic patients by sustained-release chlorhexidine dressings: results from a prospective randomized controlled trial. J Hosp Infect. 2005 Sep;61(1):53-61. doi: 10.1016/j.jhin.2005.01.023.
- Background: PubMed 18679683Ruschulte H, Franke M, Gastmeier P, Zenz S, Mahr KH, Buchholz S, Hertenstein B, Hecker H, Piepenbrock S. Prevention of central venous catheter related infections with chlorhexidine gluconate impregnated wound dressings: a randomized controlled trial. Ann Hematol. 2009 Mar;88(3):267-72. doi: 10.1007/s00277-008-0568-7. Epub 2008 Aug 5.
- Background: PubMed 28854967Ullman AJ, Kleidon T, Gibson V, McBride CA, Mihala G, Cooke M, Rickard CM. Innovative dressing and securement of tunneled central venous access devices in pediatrics: a pilot randomized controlled trial. BMC Cancer. 2017 Aug 30;17(1):595. doi: 10.1186/s12885-017-3606-9.
- Individual participant dataSharing planned: No. There is no plan to make individual participant data available to other researchers
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.
Steven L Moulton, MD principal investigator
Children's Hospital Colorado
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Central venous access device (CVAD) Snuggie Securement Device in people with Central Venous Catheter Exit Site Infection and Central Venous Catheter Related Bloodstream Infection, run by University of Colorado, Denver 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 3 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: status not confirmed, as of the sponsor's last update on 15 Jun 2023. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jenny Stevens, MD (2515899950, jenny.stevens@childrenscolorado.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comfort (time frame: 3 weeks). The study lists 11 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04462861, which also lists 9 linked publications.
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 15 Jun 2023.