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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control Group | Active Comparator | This group will be received the current standard of care (SOC) dressing method for PICC lines. |
|
| Cyanoacrylate Glue Group | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cyanoacrylate glue | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Up to 7 days |
| Measure | Description | Time Frame |
|---|---|---|
| Number of PICC Line Migrations | A PICC line migration is 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. The reported values represent the total number of PICC line migrations observed across all participants. | Until PICC line removal (approximately 12 weeks) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Marianne Garland, MD | Morgan Stanley Children's Hospital of NYP | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| NewYork-Presbyterian Morgan Stanley Children's Hospital at CUIMC | New York | New York | 10032 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33459671 | Background | 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. | |
| 33083900 | Background | 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. |
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Plan to submit the study finding to professional nursing journals, such as Advanced in Neonatal Care, Journal of Neonatal Nursing, and etc
1 to 2 years
To be determined by the PI
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| ID | Title | Description |
|---|---|---|
| FG000 | Control Group | This group will be received the current standard of care (SOC) dressing method for PICC lines. |
| FG001 | Cyanoacrylate Glue Group | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Control Group | This group will be received the current standard of care (SOC) dressing method for PICC lines. |
| BG001 | Cyanoacrylate Glue Group | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Median | Inter-Quartile Range | days | Up to 7 days |
|
12 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Control Group | This group will be received the current standard of care (SOC) dressing method for PICC lines. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Seon Mi Jeong | Columbia University | 646-317-5238 | smj9007@nyp.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Dec 6, 2022 | Jan 22, 2025 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D007232 | Infant, Newborn, Diseases |
| ID | Term |
|---|---|
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
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Randomized control study
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|
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| Standard transparent film dressing | Device | A standard transparent polyurethane film dressing, such as 3M TEGADERM Film, for dressing the PICC line area. |
|
| Background | 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. |
| 31495268 | Background | 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. |
| 28893464 | Background | 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. |
| 33148114 | Background | 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. |
| 28045704 | Background | 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. |
| BG002 | Total | Total of all reporting groups |
| days |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Secondary | Number of PICC Line Migrations | A PICC line migration is 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. The reported values represent the total number of PICC line migrations observed across all participants. | Posted | Number | PICC line migrations | Until PICC line removal (approximately 12 weeks) |
|
|
|
| 0 |
| 15 |
| 0 |
| 15 |
| 0 |
| 15 |
| EG001 | Cyanoacrylate Glue Group | 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. | 0 | 17 | 0 | 17 | 0 | 17 |
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