search
Back to results

Impact of Cyanoacrylate Glue on PICC Line Dressing Care

Primary Purpose

Central Line Complication, Neonatal Disease

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Cyanoacrylate glue
Standard transparent film dressing
Sponsored by
Columbia University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Central Line Complication focused on measuring PICC line dressing, cyanoacrylate glue, NICU

Eligibility Criteria

1 Day - 6 Months (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • All patients admitted to the 9 North intensive coronary care unit (ICCU) at NewYork-Presbyterian Morgan Stanley Children's Hospital greater than 35 weeks of corrected gestational age who have a PICC line placed by a NICU provider.

Exclusion Criteria:

  • Any patient with a PICC line in situ from an outside hospital.
  • Any patient with a PICC line placed by an outside department, namely the interventional radiology department.
  • Any patient with a PICC line that is silicon material catheter, such as Vygon Epicutaneo-Cava catheter because of limited accuracy of measuring a movement of the catheter migration after 25 centimeter mark due to absence of a centimeter mark on the catheter.

Sites / Locations

  • NewYork-Presbyterian Morgan Stanley Children's Hospital at CUIMC

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Control Group

Cyanoacrylate Glue Group

Arm Description

This group will be received the current standard of care (SOC) dressing method for PICC lines.

This group will receive a few drops of cyanoacrylate glue on PICC line site prior to application of usual standard film dressing over the PICC line site.

Outcomes

Primary Outcome Measures

Duration of longevity of PICC line dressing
Duration of longevity defined as the number of days the PICC line dressing lasts from the scheduled dressing change.

Secondary Outcome Measures

PICC line migration incidences
The incidence of PICC line migration defined as a change in the length of catheter extruding from the insertion site - a catheter migration of more than 0.25 cm will be counted as an incidence.

Full Information

First Posted
February 9, 2022
Last Updated
September 19, 2023
Sponsor
Columbia University
search

1. Study Identification

Unique Protocol Identification Number
NCT05246709
Brief Title
Impact of Cyanoacrylate Glue on PICC Line Dressing Care
Official Title
Randomized Control Study to Evaluate Impact of the Use of Cyanoacrylate Glue on PICC Line Dressing Care in the Infant Cardiac Care Unit at Children's Hospital of New York
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Completed
Study Start Date
February 26, 2022 (Actual)
Primary Completion Date
October 30, 2022 (Actual)
Study Completion Date
October 30, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Columbia University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
This study will evaluate whether applying micro drops of cyanoacrylate glue to the participant's peripherally inserted central catheter (PICC) insertion site prior to covering the area of PICC line with a transparent film dressing will make the PICC dressing last longer and prevent an occurrence of PICC line moving out of its original placement. The investigators aims to evaluate whether 1) using the cyanoacrylate glue will lengthen the time to first dressing change; and 2) participants in the experimental arm (glue used) will have fewer dressing changes per week compared to the control arm (standard care) during admission.
Detailed Description
The neonatal population poses a unique challenge due to the small surface area of PICC sites, underdeveloped skin layer, and inability to contain the child's movements during a dressing change. PICC line migration is the most common complication of PICC line maintenance in the neonatal intensive care unit (NICU). Previous studies have found that the PICC migration/dislodgment mostly occurs during PICC dressing changes among the neonatal population. Recent published studies demonstrated that medical tissue adherence glue, Cyanoacrylate, significantly reduces the incidences of catheter migration and insertion site bleeding of PICC lines in all age of patients including premature infants. The proposed study is a randomized control study with aimed data collection of 60 participants; of the 60 participants, 50 participants' data are to be used for statistical analysis and additional 10 participants to account for withdrawals. The participants will be randomly assigned to one of two groups: one (the control group) receiving our standard PICC dressing method and the other (the study group) receiving cyanoacrylate glue at the PICC insertion sites prior to applying a standard transparent film dressing over the PICC sites. The control group will reflect standard practice of PICC insertion and dressings using a standard transparent polyurethane film dressing, 3M TEGADERM Film. The study group will reflect the application of a few drops of cyanoacrylate glue, SecurePortIVTM by Adhezion Biomedical® at the insertion sites prior to dressing a PICC line area with a standard transparent polyurethane film dressing. The aim for this study is to investigate whether the application of cyanoacrylate glue at the insertion sites prior to dressing a PICC line area with a standard dressing will increase the longevity of the PICC line dressing and reduce the incidences of PICC line migration.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Central Line Complication, Neonatal Disease
Keywords
PICC line dressing, cyanoacrylate glue, NICU

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized control study
Masking
None (Open Label)
Allocation
Randomized
Enrollment
32 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control Group
Arm Type
Active Comparator
Arm Description
This group will be received the current standard of care (SOC) dressing method for PICC lines.
Arm Title
Cyanoacrylate Glue Group
Arm Type
Experimental
Arm Description
This group will receive a few drops of cyanoacrylate glue on PICC line site prior to application of usual standard film dressing over the PICC line site.
Intervention Type
Device
Intervention Name(s)
Cyanoacrylate glue
Other Intervention Name(s)
SecurePortIV® Catheter Securement Adhesive
Intervention Description
Adhesive to be applied on the PICC line site prior to usual standard film dressing over the site, such as SecurePortIV® Catheter Securement Adhesive by Adhezion Biomedical® Cyanoacrylate adhesive that is FDA-approved for securement of vascular access devices. Securement method that provides microbial protection by sealing the insertion site.
Intervention Type
Device
Intervention Name(s)
Standard transparent film dressing
Intervention Description
A standard transparent polyurethane film dressing, such as 3M TEGADERM Film, for dressing the PICC line area.
Primary Outcome Measure Information:
Title
Duration of longevity of PICC line dressing
Description
Duration of longevity defined as the number of days the PICC line dressing lasts from the scheduled dressing change.
Time Frame
Up to 7 days
Secondary Outcome Measure Information:
Title
PICC line migration incidences
Description
The incidence of PICC line migration defined as a change in the length of catheter extruding from the insertion site - a catheter migration of more than 0.25 cm will be counted as an incidence.
Time Frame
Until PICC line removal (approximately 12 weeks)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
1 Day
Maximum Age & Unit of Time
6 Months
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: All patients admitted to the 9 North intensive coronary care unit (ICCU) at NewYork-Presbyterian Morgan Stanley Children's Hospital greater than 35 weeks of corrected gestational age who have a PICC line placed by a NICU provider. Exclusion Criteria: Any patient with a PICC line in situ from an outside hospital. Any patient with a PICC line placed by an outside department, namely the interventional radiology department. Any patient with a PICC line that is silicon material catheter, such as Vygon Epicutaneo-Cava catheter because of limited accuracy of measuring a movement of the catheter migration after 25 centimeter mark due to absence of a centimeter mark on the catheter.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marianne Garland, MD
Organizational Affiliation
Morgan Stanley Children's Hospital of NYP
Official's Role
Principal Investigator
Facility Information:
Facility Name
NewYork-Presbyterian Morgan Stanley Children's Hospital at CUIMC
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Plan to submit the study finding to professional nursing journals, such as Advanced in Neonatal Care, Journal of Neonatal Nursing, and etc
IPD Sharing Time Frame
1 to 2 years
IPD Sharing Access Criteria
To be determined by the PI
Citations:
PubMed Identifier
33459671
Citation
Acun C, Baker A, Brown LS, Iglesia KA, Sisman J. Peripherally inserted central cathether migration in neonates: Incidence, timing and risk factors. J Neonatal Perinatal Med. 2021;14(3):411-417. doi: 10.3233/NPM-200684.
Results Reference
background
PubMed Identifier
33083900
Citation
Bierlaire S, Danhaive O, Carkeek K, Piersigilli F. How to minimize central line-associated bloodstream infections in a neonatal intensive care unit: a quality improvement intervention based on a retrospective analysis and the adoption of an evidence-based bundle. Eur J Pediatr. 2021 Feb;180(2):449-460. doi: 10.1007/s00431-020-03844-9. Epub 2020 Oct 20.
Results Reference
background
Citation
D'Andrea V, Pezza L, Barone G, Pronterà G, Pittiruti M, Vento G. Comparison study: before/after the practice change of the use of medical cyanoacrylate glue for securing ECC (epicutaneo-caval catheter). The Journal of Vascular Access. 2021; 00(0). 1-4.
Results Reference
background
PubMed Identifier
31495268
Citation
Guido A, Zhang S, Yang C, Pook L. An innovative cyanoacrylate device developed to improve the current standard of care for intravascular catheter securement. J Vasc Access. 2020 May;21(3):293-299. doi: 10.1177/1129729819872881. Epub 2019 Sep 9.
Results Reference
background
PubMed Identifier
28893464
Citation
Kleidon TM, Ullman AJ, Gibson V, Chaseling B, Schoutrop J, Mihala G, Rickard CM. A Pilot Randomized Controlled Trial of Novel Dressing and Securement Techniques in 101 Pediatric Patients. J Vasc Interv Radiol. 2017 Nov;28(11):1548-1556.e1. doi: 10.1016/j.jvir.2017.07.012. Epub 2017 Sep 19.
Results Reference
background
PubMed Identifier
33148114
Citation
Ostroff M, Zauk A, Chowdhury S, Moureau N, Mobley C. A retrospective analysis of the clinical effectiveness of subcutaneously tunneled femoral vein cannulations at the bedside: A low risk central venous access approach in the neonatal intensive care unit. J Vasc Access. 2021 Nov;22(6):926-934. doi: 10.1177/1129729820969291. Epub 2020 Nov 5.
Results Reference
background
PubMed Identifier
28045704
Citation
Sharpe E, Kuhn L, Ratz D, Krein SL, Chopra V. Neonatal Peripherally Inserted Central Catheter Practices and Providers: Results From the Neonatal PICC1 Survey. Adv Neonatal Care. 2017 Jun;17(3):209-221. doi: 10.1097/ANC.0000000000000376.
Results Reference
background

Learn more about this trial

Impact of Cyanoacrylate Glue on PICC Line Dressing Care

We'll reach out to this number within 24 hrs