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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
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.
Age
0 - 0 years
Sex
ALL
Healthy Volunteers
No
NewYork-Presbyterian Morgan Stanley Children's Hospital at CUIMC
New York, New York, United States
Start Date
February 26, 2022
Primary Completion Date
September 15, 2022
Completion Date
November 16, 2022
Last Updated
June 26, 2025
32
ACTUAL participants
Cyanoacrylate glue
DEVICE
Standard transparent film dressing
DEVICE
Lead Sponsor
Columbia University
NCT07166172
NCT06187831
Data Source & Attribution
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