Peripheral Intravenous Catheter Securement With Tissue Adhesive Compared to Conventional Dressing: A Randomized Controlled Trial
Phase: NA
Conditions: Vascular Access Devices
Sponsor: Corewell Health East

 
TITLE: Peripheral Intravenous Catheter Securement With Tissue 
Adhesive Compared to Conventional Dressing: A Randomized 
Controlled Trial   
 
NCT04086693 
 
6/16/2020 

06.15.2020
Peripheral Intravenous Catheter Securement with Tissue 
Adhesive Compared to Conventional Dressing: A 
Randomized Controlled Trial 
Background/Scientific Rationale:
Nearly all hospitalized patients require intravenous (IV) access for treatment. 
Patients rely on functional vascular access to receive life saving IV therapies. 
Generally, peripheral IVs have high failure rates with 19-25% of IVs failing prior to 
completion of therapy and 45-56% of ultrasound-guided peripheral IVs failing prior 
to completion of therapy. Dislodgment, infiltration/extravasation, and phlebitis are 
common complications that lead to early failure. 1-5 IV restarts are a common 
procedure and are unfortunately simply a part of a normal workday for nurses.  A 
failure rate of up to 56% in a technology that is over 75 years old is unacceptable.
If access is lost, patients may experience treatment delays, dissatisfaction from 
repeat needle-sticks, and health complications if the patient’s condition becomes 
critical.  IV failure can result in a number of negative health/quality outcomes 
including phlebitis and infections and/or skin necrosis from caustic medication 
infiltration; utilization of invasive procedures such as peripherally inserted central 
catheters (PICC) and central lines; and wasted medical/nursing time.6
Because failure rate is high, it is important to approach insertions methodically to 
improve survival rates. One area of opportunity is securement of the catheter. 
Accidental dislodgment is a common cause of early IV failure accounting for up to 
50% of catheter failures.7 Beyond dislodgment, inadequate fixation of the catheter 
to the patient’s skin causes micromotion, leading to vein irritation and entry of skin 
bacteria into the entry site. This micromotion leads to phlebitis, occlusion, and 
infection.8 Standard practice for securement involves placement of a polyurethane 
dressing with clear tape. A variety of additional devices are available on the market 
including tissue adhesives, specially designed securement dressings, and sutureless 
securement devices. The evidence suggests the use of tissue adhesives may decrease 
peripheral IV failure with a decrease in dislodgments and occlusions compared to 
the alternatives.8 Bugden et al. found that skin glue reduced catheter dislodgment by 
7% and reduced peripheral IV failure by 10%.9
While some evidence supports the use of tissue adhesives for securement, further 
randomized controlled trials are needed to assess the effectiveness of this 
intervention. Further, only one prospective, randomized trial evaluated patients in 
the emergency room setting. Nearly 50% of all hospital admissions start in the 
emergency department (ED) and 80% of hospitalized patients require IV 
access.  This highlights the importance of understanding the impact of tissue 
adhesives on peripheral IV survival for patients admitted through the ED. While 
Bugden found that skin glue reduced IV failures for patients hospitalized from the 
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ED, patients were only followed for 48 hours. The general consensus is to continue 
using IVs as long as there is no clinical indication for removal. 10 As the average 
hospital length of stay in the United States is 4-6 days, it is clear that the 48 hour 
cutoff is a critical flaw in the analysis and further investigation over a longer time 
period is urgently needed. 
We propose a prospective randomized controlled trial to evaluate peripheral IV 
failure with ED patients that are hospitalized comparing securement with standard 
securement plus Adhezion Biomedical SecurePortIVTM to standard securement.
Specific Aim 1: Test the prediction that the experimental securement solution of 
standard dressing plus Adhezion Biomedical SecurePortIVTM will have a lower 
probability of failure compared to the control standard of care securement.
For Aim 1, an improved survival of the experimental securement solution will be 
evaluated by functionality of catheter for intravenous therapy prior to patient 
discharge. The event is failure of functionality identified during follow-up 
assessment during hospitalization. Duration of dwell and functional failure of the 
catheter will be employed to estimate catheter survival.  
Specific Aim 2: Determine the difference in cause-specific IV failure rates between 
the experimental and control groups. Specific etiologies to be evaluated include 
dislodgment, infection, phlebitis, and occlusion.
Specific Aim 3: Determine the difference in costs associated with the experimental 
group versus the control group. Cost calculation will include all costs of placement 
in each group: labor and material. 
Study Design:
We propose a prospective, single-site, parallel, two-arm randomized investigation of 
catheter survival when securement strategies are evaluated. Specifically, 
conventional securement with polyurethane dressing and tape will be compared 
with experimental securement with tissue adhesive, polyurethane dressing and 
tape. The primary objective of this study is to demonstrate that there is better 
survival of the catheter securement with the tissue adhesive. Exploratory secondary 
and adjusted multivariable analyses will also be conducted.  
Pre-Enrollment Staff Training: 
The proper application of the tissue adhesive requires some education and training 
of staff. Research staff performing patient enrollments will be trained to place the 
tissue adhesive by the Adhezion clinical/education team. A possible training may 
include a short didactic and hands-on session and application of the solution on 
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healthy volunteers/patients. Enrollment will begin once staff are deemed proficient 
in the procedure.
 
Study Population and Eligibility: 
Inclusion Criteria:
A convenience sample of patients with expected greater than 48 hours admission 
likelihood will be eligible for enrollment.
1. All adult patients greater or equal to 18 years of age
2. Admission from the ED to a progressive floor expected for over 48 hours OR 2a: 
Admission from ED to any floor type with express approval from the Principal 
Investigator
3. IV placement in the antecubital fossa, forearm, wrist or hand
4. IV placement in the Emergency Department 
5. Enrollment within 8 hours of IV insertion
6. 18 or 20 gauge 1.16 inch IV catheter
Exclusion Criteria:
1. Patients with ultrasound-guided IV insertions
2. Alternate site of cannulation 
3. Voluntary withdrawal
4. Patients with a non-standard polyurethane dressing
5. Known allergy to cyanoacrylate or formaldehyde
The survival analysis will only be performed on patients that have an IV dwell time 
greater than 48 hours. Over 85% of patients admitted to a progressive floor have 
length of stay greater than 48 hours. The sample size calculation reflects an 
assumed 10 - 15% exclusion rate. 
Study Procedure:
Initial Assessment:
Patients admitted from the ED to a progressive floor are eligible participants. 
Research staff will approach a convenience sample of patients admitted to the 
progressive floors based on screening of the electronic medical record. These 
patients are admitted to a progressive floor but approached by research staff when 
physically in the emergency department waiting for a room assignment. The 
principal investigator may also choose to include additional patients admitted to 
non-progressive inpatient units. The principal investigator will inform the research 
staff when such cases arise. Similar to other study subjects, these patients will be 
approached in the Emergency Department. If the patient agrees to participate in the 
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trial, the study subject will be consented by the research staff. Research staff will 
confirm functionality of the existing IV previously placed by ED staff. The 
assessment will include observing for blood return into the tubing upon aspiration 
and/or unobstructed flush with a minimum of 1-2 ml of normal saline. Staff will also 
observe the site for any signs of redness or tenderness. 
A tourniquet may be applied as needed. If the patient is actively receiving an 
infusion, the drip will briefly be halted to evaluate for functionality. Functionality 
will be assessed with the existing dressing in place. If the catheter is functional and 
free of any signs of complications, study subjects will be randomized by a computer 
generated 1:1 envelope system to either the control group: polyurethane dressing + 
clear tape or the experimental group: polyurethane dressing + clear tape + tissue 
adhesive. If the IV is not functional, a new catheter will be inserted in a new location, 
documented, and patient continues in the study. For the control group, the 
polyurethane dressing will be gently removed. Dressing will be removed carefully to 
minimize any potential dislodgments or skin injury. The site will be evaluated for 
oozing or blood and as needed cleaned with sterile gauze. Once the site is 
completely dry, a new polyurethane dressing will be applied and reinforced with 
tape in a standard fashion. See Appendix A for pictures depicting standard dressing 
application with tape. Once securement is complete, functionality will be reassessed 
per protocol above. For the experimental group, the existing securement will be 
gently removed. The site will be evaluated for oozing or blood and as needed 
cleaned with sterile gauze. Once the site is completely dry, the tissue adhesive will 
be applied per directions in Appendix B. A new standard polyurethane dressing will 
be applied and tape will be applied per the standard approach. Once securement is 
complete, functionality will be reassessed per protocol above. The time of the new 
dressing application will be noted as time zero. Catheter dwell time will begin at this 
point. 
Additional data variables collected at the initial assessment include: demographics 
such as age, sex, INR>1.5, platelets < 50, insertion site details, hours from insertion 
to recruitment, inserter credentials.
Follow-up Assessment: 
After initial assessment, the catheter will be assessed by the research team every 24 
+/- 5 hours as long as the patient is hospitalized up to 7 days or 168 hours. At each 
follow up interval the researcher notes the date/time of evaluation and assesses for 
any signs and symptoms of complications and functionality of the device. A catheter 
is functional if the IV flushes without resistance. Catheters will be assessed daily for 
signs and symptoms of complications.11 See Appendix C for details regarding the 
assessment for complications. Any signs or symptoms of complications or lack of 
functionality will be reported to the patient’s primary care team so that 
management of the IV catheter can be addressed. If the catheter and adhesive are 
removed early due to catheter failure or complication, or for patient discharge prior 
to 7 days a medical adhesive remover may be used.
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If the catheter was identified to have any signs or symptoms of complications during 
follow-up assessment the date and time of observation of the complication will be 
documented in the data collection tool and the primary team will be notified of the 
complication. If the catheter was removed prior to the follow-up assessment then 
the IV removal time and the reason for removal will be obtained through chart 
review. For all catheters removed due to a complication, re-insertion attempt data 
will be tracked through the medical record in the nursing section for venous lines 
and need for reinsertion of the IV or escalation to a midline, PICC, or CVC will be 
noted. If the patient is discharged prior to the time of follow-up assessment then the 
time of discharge will be documented and the IV will be presumed functional until 
time of discharge unless otherwise noted in the chart.
The medication administration record will be queried for all medications given 
through each catheter with specific attention to antibiotics and anticoagulants. 
Vesicants/irritants that are generally given via central line or considered caustic to 
the vessel will be noted in both groups. Number of doses will be recorded. See 
Appendix D for full list of non-neoplastic vesicants. 
Additional data gathered by research staff on follow-up evaluation includes: dwell 
time in days/hours, hospital length of stay, and number of peripheral IVs for 
duration of stay. 
Appendix E represents the data collection documentation tool for all catheter 
follow-ups. 
Statistical Rationale and Analysis Plan: 
Sample Size and Power Analysis 
For this randomly allocated two-groups experiment, the primary outcome is 
catheter survival associated with securement devices. Sample size calculation is 
based on primary outcome: composite or all cause premature removal due to 
complication of the IV catheter. Based on existing literature, the maximum mean 
failure rate across major investigations is 25% which functions as the estimated 
failure rate of the standard of care group.  Assuming a minimum difference of 10% 
needed for prompting a change in practice and based on existing literature, the 
experimental group  (standard of care plus tissue adhesive) is hypothesized to have 
a composite failure rate of 15%. 154 subjects per group for a total sample size of 
308 subjects is the minimum recommendation assuming a 10% dropout rate. To 
account for a larger dropout percentage, 350 patients or 175 subjects per group is 
the final sample size to provide 80% power to detect a significant effect.  
Statistical Analysis 
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Characteristics of enrolled patients will be summarized using means [standard 
deviations] and medians [interquartile ranges] for continuous variables, and 
frequencies (percentages) for categorical variables. Exploratory data analyses 
including histograms, Pareto charts, scatter plots, and box plots will be further used 
to show the distribution. Appropriate transformations and estimation procedures 
will be performed as necessary. To test the effect of securement strategies on each 
of aims, we will further use Cox proportional hazard regression models for time-to-
event outcomes and logistic regression models for binary outcomes. P-values of less 
than 0.05 will be considered statistically significant. Analysis will be conducted 
using SAS 9.4.
 
Data Collection/Management Plan:
Data will be collected as subjects are enrolled and information will be stored in a 
password protected excel file until ready for statistical analysis. 
Publication and Presentation Plan:
The publication plan is to submit a manuscript to a high impact medical journal. 
This publication has the potential to significantly change securement practice and 
enhance quality for patients. The study results will also be presented at least one 
national meeting and potentially additional vascular access conferences. 
Potential Impact:
Optimization of peripheral vascular care is a critical strategy to improve patient 
outcomes and reduce health care costs. Enhanced dwell times will lead to improved 
patient/staff satisfaction, decreased interruptions in care with shorter hospital 
length of stay, and decrease in complications such as thrombosis, bleeding, and 
infection. At the Royal Oak campus, over 450,000 IV catheters are purchased 
annually. Across the health system, this number exceeds 2 million catheters per 
year. In a study by Rickard et al in 2012, a patient required an average of 1.7 IV 
catheters per admission.10 With a cost of approximately $35 per catheter for 
straightforward insertions, even a slight improvement in dwell time has the 
potential to save our health system millions of dollars. 
Principal Investigator: 
Amit Bahl, MD is the principal investigator and lead author for this investigation. He 
is board-certified in Emergency Medicine and subspecializes in Emergency 
Ultrasound. Further, Dr. Bahl serves as the medical director of the inpatient Vascular 
Access Team at Beaumont Royal Oak campus. He has authored a number of peer-
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reviewed manuscripts with a key focus on ultrasound-guided vascular access. He 
recently completed three randomized controlled trials assessing catheter dwell time 
with ultrasound-guided IV insertions. 
Site: 
Beaumont Health is Michigan’s largest health care system and is the most preferred 
for health care in the tri-county area, according to National Research Corporation 
survey data. A not-for-profit organization, it was formed in 2014 by Beaumont 
Health System, Botsford Hospital and Oakwood Healthcare to provide patients with 
the benefit of greater access to extraordinary, compassionate care, no matter where 
they live in Southeast Michigan. Beaumont Health has total net revenue of $4.5 
billion and consists of eight hospitals with 3,429 beds, 187 outpatient sites, nearly 
5,000 physicians, 38,000 employees and 3,500 volunteers. In 2017, Beaumont 
Health had 175,700 inpatient discharges, 17,800 births and 575,000 emergency 
visits.
William Beaumont Hospital, Royal Oak (RO) campus is the proposed site for the 
investigation. It is a 1,100 bed major academic and referral center with Level 1 adult 
trauma and Level 2 pediatric trauma status. A major teaching facility, Beaumont, 
Royal Oak has 55 residency and fellowship programs with 454 residents and 
fellows. Beaumont is the exclusive clinical partner for the Oakland University 
William Beaumont School of Medicine. The Beaumont Research Institute was 
established more than 30 year ago at Royal Oak and offers research support services 
to clinical investigators.
References:
1.
Bregenzer T, Conen D, Sakmann P, et al. Is routine replacement of peripheral 
intravenous catheters necessary? Arch Intern Med. 1998;158(2):151-156.
2.
Catney MR, Hillis S, Wakefield B, et al. Relationship between peripheral 
intravenous catheter Dwell time and the development of phlebitis and 
infiltration. J Infus Nurs. 2001;24(5):332-341.
3.
Dargin JM, Rebholz CM, Lowenstein RA, et al. Ultrasonography-guided 
peripheral intravenous catheter survival in ED patients with difficult access. 
Am J Emerg Med. 2010;28(1):1-7.
4.
Elia F, Ferrari G, Molino P, et al. Standard-length catheters vs long catheters 
in ultrasound-guided peripheral vein cannulation. Am J Emerg Med. 
2012;30(5):712-716.
5.
Soifer NE, Borzak S, Edlin BR, et al. Prevention of peripheral venous catheter 
complications with an intravenous therapy team: a randomized controlled 
trial. Arch Intern Med. 1998;158(5):473-477.
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6.
Dychter SS, Gold DA, Carson D, et al. Intravenous therapy: a review of 
complications and economic considerations of peripheral access. J Infus Nurs. 
2012;35(2):84-91.
7.
Helm, RE, Klaunser, JD, Klemperer, JD, Flint, LM, Huang, E, Accepted but 
Unacceptable:  Peripheral IV Catheter Failure. Journal of Infusion Nursing. 
2015;38(3):189-203.
8. 
Rickard C, Marsh N, Webster J, Runnegar N et al. Dressings and securements 
for the prevention of peripheral intravenous catheter failure in adults 
(SAVE): a pragmatic randomised controlled, superiority trial. Lancet. 
2018;392:419-30.
9. 
Bugden S, Shean K, Scott M, Mihala G, et al. Skin glue reduces failure rate of 
emergency department-inserted peripheral intravenous catheters: a 
randomized controlled trial. Annals of Emergency Medicine. 2016;68(2):196-
201.
10. 
Rickard CM, Webster J, Wallis MC. Routine versus clinically indicated 
replacement of peripheral intravenous catheters: a randomized controlled 
equivalence trial. Lancet. 2012;380 (9847):1066-1074.
11.
Gorski L, Hadaway L, Hagle M, McGoldrick M, et al. Infusion Therapy: 
Standards of Practice. Journal of Infusion Nursing. 2016;39(1S): S91
 
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Appendix A: Standard Dressings with Securement
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Appendix B: Tissue Adhesive Application Instructions
Point the tip towards the ceiling and away from the 
patient.  Press the bottom of the applicator upward.
Invert the applicator and gently squeeze the ridges to 
initiate adhesive flow. Place 1-2 drops of adhesive at the 
catheter-skin junction.
Allow each drop of glue to “set-up” for a few seconds 
before adding the next drop.
Make sure the tissue adhesive is surrounding the entire 
circumference of the catheter. 
Place an additional 1-2 drops of adhesive under the 
catheter hub/extension set connection.
  Apply gentle pressure for 30 seconds to ensure 
securement between the catheter and the skin surface. 
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As desired, the remaining adhesive can be spread out 
beyond the area of the catheter to increase dressing 
adherence.
After application of SecurePortIV, a transparent film 
dressing should be applied per facility protocol.
Appendix C: Signs and Symptoms of Catheter-Related 
Complications
1. Any level of pain and/or tenderness with or without palpation
2. Changes in color (erythema or blanching)
3. Changes in skin temperature (hot or cold)
4. Edema
5. Induration
6. Leakage of fluid or purulent drainage from the puncture site
7. Other dysfunction (e.g. resistance with flushing, lack of blood 
return
Appendix D: List of Vesicants/Irritants
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Appendix E: Follow Up: 
Day
Functional
1: draw
2: flush
3: infusing
4: failed
Removal 
Time
Reason for 
Removal
Signs/Symptoms 
of Complications
Rescue 
Device           
1.PIV  
2. USPIV
3. CVC
4. PICC
5. Midline
6. IO              
Discharge <48hrs 
from insertion (if 
yes, remove 
patient from 
study)
Research 
staff 
initials
1
2
3
4
5
6
7
8
9
10
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Reasons for Removal: (1) completion of therapy (2) infiltration (3) phlebitis 
(4) dislodgement  (5) oozing fluid/blood (6) purulent drainage (7) occlusion 
(8) removed by patient (9) site changed (10) other
Day
Medications transfused via catheter
1
2
3
4
5
6
7
8
9
10
Signature/Date (completer of post data): 
________________________________________________________________________
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