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
Phase: NA
Conditions: Central Line Complication, Neonatal Disease
Sponsor: Columbia University

 
 
 
 
 
 
 
 
 
Impact of Cyanoacrylate Glue on PICC Line 
Dressing Care 
 
NCT05246709 
 
IRB approval date: 12/06/2022 
 
 

BACKGROUND 
 
In the Neonatal Intensive Care Unit (NICU) and the Infant Cardiac Care Unit (ICCU) at 
Children’s Hospital of New York (CHONY), a peripherally inserted central catheter (PICC) is a 
crucial way to provide high osmotic parental nutrition and to safely administer caustic 
medications. Almost all patients admitted to these units, from the extremely low birth weight 
infant to the full-term infant with congenital heart defects, require a PICC line during their 
hospitalization. The dwelling times for a PICC line in this population vary from less than 7 days 
to as long as 5 months according to an in-patient chart review. Maintenance of the PICC 
insertion site including the integrity of the PICC dressing are paramount in preventing iatrogenic 
complications such as infection, phlebitis, thrombosis, infiltration, catheter migration and 
catheter dislodgement. The neonatal population poses a unique challenge due to the small surface 
area of PICC sites, underdeveloped skin layer, and the 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 NICU (Sharpe et al., 2017). The PICC migration/dislodgement mostly occurs 
during PICC dressing changes among the neonatal population (Acun et al., 2020). Inadvertent 
PICC line migration out of its central location into a peripheral vein as a result of dressing 
changes, increases PICC related complications by 3 to 8 times (Sharpe, 2014). 
In our NICU/ 9North ICCU, the policy for PICC dressing change is every 7 days or 
whenever the integrity of the dressing is compromised (see the attached document for the NICU 
PICC dressing change guideline). Integrity is often compromised as a result of blood at the 
insertion site or lack of adherence of the dressing to the skin. For patients in the NICU/9 North 
ICCU, it is a common observation that PICC lines are often dislodged from their central position 
as a result of frequent dressing changes. Medical tissue adherence glue, Cyanoacrylate, has been 
safely used for hemostasis, wound closure, or fistula repair (ASGE, 2013; Nose et al. 2016) and 
has been shown to significantly reduce the incidence of catheter migration and insertion site 
bleeding of PICC lines in all age of patients including premature infants (Bierlaire et al., 2021; 
D’Andrea et al., 2021; Kleidon et al., 2017; Ostroff et al, 2020; Scoppettuolo et al., 2013). One 
of the tissue adhesive glues on the USA market is SecurePortIVTM by Adhezion Biomedical®. 
This product is the first FDA approved cyanoacrylate that is intended to secure venous catheters 
including PICC lines (Guido et al., 2020). This product is a mixture formula of n-butyl and octyl 

cyanoacrylate that provides prevention of bleeding at the insertion site, a microbial barrier from a 
mechanical seal at the insertion site, and securement of both the catheter at the insertion site and 
the catheter hub (Guido et al., 2020). Despite the evidence of the efficacy of cyanoacrylate glue 
in bleeding control at the insertion site of PICC lines and reduction of catheter migration, there is 
still a gap of knowledge for our NICU to confidently adopt cyanoacrylate glue as our standard 
practice of PICC line maintenance care. The purpose of this study is to evaluate the efficacy of 
this FDA approved medical tissue adhesive glue applied to PICC insertion sites to reduce the 
number of dressing changes required due to bleeding at the insertion site and to reduce catheter 
migration. This study will focus strictly on those patients admitted to the 9 North ICCU who 
require PICC lines. 
 
RESEARCH AIMS & ABSTRACTS 
 
Research Question(s)/Hypothesis(es): 
Research question: Does the use of a cyanoacrylate glue effect the interval time between 
routine PICC line dressing changes and the incidence of PICC line migration in patients admitted 
to the 9 North ICCU? 
 
Hypotheses: 
The application of micro drops of cyanoacrylate glue at the insertion sites prior to 
dressing a PICC line area with a standard transparent polyurethane film dressing will increase the 
longevity of the PICC line dressing and reduce the incidences of PICC line migration. 
 
Scientific Abstract: 
The most common complication related to PICC line maintenance and care is a catheter 
migration in the neonatal population. Frequent PICC dressing changes is a commonly observed 
culprit of PICC line migration in the NICU. This study is a randomized control study to 
investigate an application of a cyanoacrylate glue to determine its impact on the duration of the 
PICC line dressings and the occurrence of PICC migration. All patients in 9 North ICCU with 
PICC lines will be eligible to participate in this study. 

Once patients needing a PICC line are enrolled into the study, they will be randomly assigned to 
two groups: control and study. The control group will receive the current standard method of 
securing a PICC line. The study group will receive a new way of securing PICC line with a 
cyanoacrylate glue in addition to a transparent film dressing over the PICC line site. 
The subjects who do not participate in the research will receive regular medical care. 
Also, NICU providers who perform a PICC insertion procedure and designated nursing staff who 
perform a PICC line dressing change will be surveyed anonymously to assess the acceptability of 
the use of the glue. The survey will be filled out voluntarily. 
If the application of cyanoacrylate glue at the insertion site demonstrates an increase in 
longevity of PICC line dressing and a reduction of PICC line migration, then its use can be 
incorporated as a standard care of neonatal PICC insertion and maintenance in 9 North ICCU. 
 
Study Design: 
The proposed study is a randomized control study with aimed data collection of 60 
subjects; of the 60 subjects, 50 subject data are to be used for statistical analysis and additional 
10 subjects to account for withdrawals. 
The subjects 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 dressing a PICC line area with a standard 
transparent film dressing. The control group will reflect our standard practice of PICC insertion 
and dressings using a standard transparent polyurethane film dressing, 3MTMTegadermTM 
Film. The study group will reflect the application of micro 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 data will be collected from the 
electronic medical records. This study will be conducted in the 9 North Infant Cardiac Care unit 
at CHONY. 
Sample: Patients in the 9 North ICCU who have a PICC line placed during their 
hospitalization. 
Inclusion and exclusion criteria: 
Inclusion: All patients admitted to the 9 North ICCU greater than 35 weeks of corrected 
gestational age who have a PICC line placed by a NICU provider. 

Exclusion: 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. 
 
Study variables: 
Independent variables: Gestational age, Postconceptural age, Sex, Diagnosis, Catheter 
size, PICC insertion site, Cyanoacrylate glue, and 3MTMTegadermTM Film dressing. 
Dependent variables: The interval of time between initial insertion and first dressing 
change, the interval of time between dressing changes after the first dressing change, and the 
incidence of catheter migration from the initial documented insertion measurement. 
 
Statistical analysis plan: 
Data will be analyzed by utilizing unpaired T-test to compare control group (standard 
transparent film dressing, 3MTMTegadermTM Film) and study group (micro drops of 
cyanoacrylate glue in addition to the standard transparent film dressing) on the interval of time 
between each dressing change and the incidence of catheter migration. 
Also, multiple general linear regression will be used to control for the effects of potential 
covariates (age, sex, diagnosis, catheter size, & PICC insertion site) on the outcome. 
As per our CLABSI (central line-associated bloodstream infections) surveillance quality 
assurance data of PICC lines previously inserted in 34 randomly chosen patients in the ICCU. 
Findings were that the average day patients were getting their first dressing change after the 
insertion was at 2.7 days with a standard deviation of 1.66 days. Our hypothesis (Hypothesis I) is 
that using the cyanoacrylate glue, we expect that the day of first dressing change will be 
significantly longer, approaching 7 days which is the current practice standard of recommended 
PICC line dressing change. Using this information, if we were to hypothesize that using the glue 
would extend the mean dressing change to 4 days in the experimental group, assuming an alpha 
of 0.05 and Power of 80%, we would need to include 24 study subjects in each group. 

We further hypothesize (Hypothesis II) that over the course of the stay for any patient for 
whom the glue was used, that patient will have experienced fewer dressing changes per week 
compared to patients receiving the standard care. 
Lastly, based on available quality assurance data showing the average centimeter of 
catheter migration was 0.875 cm with a standard deviation of 0.777 cm, we hypothesize that 
patient receiving the cyanoacrylate glue will experience significantly reduced catheter migration. 
Based on this assumption, if we were to aim for a mean catheter migration in a study group of 
0.25 cm, assuming an alpha of 0.05 and Power of 80%, we would need to study 25 subjects each 
group to prove this hypothesis. 
We are planning to recruit total of 60 subjects to allow for up to 10 withdrawal due to 
failure to use the glue or missing follow up data in the medical records. 
 
REFERENCES 
 
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