Clinical Evidence > Clinical Evidence Summaries

STATLOCK® Stabilization Device Clinical Studies:

STATLOCK® IV Stabilization Device

Improving Short Peripheral IV Outcomes: A Clinical Trial of Two Securement Methods

Timothy Royer, The Journal of the Association for Vascular Access (JAVA), 2003, Vol. 8, No. 4, pg. 1-6.

  • Peripheral IV
  • Prospective, nonrandomized, sequential, observational study
  • STATLOCK® IV Ultra Stabilization Device and tape
  • VA Puget Sound
  • Acute medical unit and surgical unit
  • n = 86 with tape, n = 36 with STATLOCK® IV Ultra Stabilization Device
  • Observed rates:
    • Restarts: tape 41%, STATLOCK® Device 15%
    • Total complications: tape 47%, STATLOCK® Device 22%
  • Statistical testing not performed

Peripheral Intravenous Catheter Dwell Times: A Comparison of Three Securement Methods for Implementation of a 96-Hour Scheduled Change Protocol

Bonnie Smith, Journal of Infusion Nursing, January/February 2006, Vol. 29, No. 1, pg. 14-17.

  • Peripheral IV
  • STATLOCK® IV Ultra Stabilization Device, HubGuard® and tape
  • Holmes Regional Medical Center, Melbourne, FL
  • Prospective, nonrandomized, sequential, observational study
  • n = 73 with tape
  • n = 286 with STATLOCK® IV Ultra Stabilization Device (phase 1 and phase 2)
  • n = 300 with HubGuard®
  • 96 hour IV protocol
  • Observed rates:
    • 8% PIV survival rate with tape
    • 9% survival rate with HubGuard®
    • 52% PIV survival rate with STATLOCK® IV Ultra Stabilization Device
  • P < .001 STATLOCK® device vs. tape or HubGuard®

Other resources:

Catheter Securement Device Provides Substantial Cost Savings; Robert Inbornone, Healthcare Purchasing News, June 2005.
Securing Quality and Safety Without Tape; Holmes Regional Medical Center; Susan Birk, Materials Management in Health Care, June 2007, Vol. 16, No. 6.

Summary of Product Trials for 10,164 Patients: Comparing an Intravenous Stabilizing Device to Tape

Gregory J. Schears, Journal of Infusion Nursing, July/August 2006, Vol. 29, No. 4, pg. 225-230.

  • Peripheral IV
  • Prospective, nonrandomized, sequential, observational study
  • Pooled data
  • 83 hospitals
  • 10,164 patients
  • 67% reduction in total complications
  • 76% reduction in unscheduled PIV restarts
  • Estimated $18,000 annual savings on PIV materials in sample hospital
  • Estimated $277,000 annual savings on materials, complications costs and nursing time in a sample hospital
  • P = .0001 for unscheduled restarts with the stabilizing device vs. tape

A Prospective Study of Two Intravenous Catheter Securement Techniques in a Skilled Nursing Facility

Kathy Sheppard, Journal of Intravenous Nursing, May/June 1999, Vol. 22, No. 3, pg. 151-156.

  • Skilled nursing facility/homecare
  • Peripheral IV
  • Prospective, nonrandomized, sequential, observational study
  • STATLOCK® IV Stabilization Device and tape
  • n = 30
  • 12.5/1,000 catheter days decrease in complications
  • 5.27/1,000 catheter days decrease in unscheduled catheter restarts
  • Dwell time extended to 3.95 days with the STATLOCK® Device compared to 2.45 days with tape
  • 13.5 minutes/patient reduction in time spent managing access device

Optimizing IV Therapy in the Elderly: Manufactured Catheter Stabilization Devices Make Their Case in Multiple Studies

Bonnie Smith, R.N., C.R.N.I. and Frances Hannum, B.A., B.S., Advance For Nurses, August 25, 2008.

  • Stabilization with a manufactured device – rather than tape – helps address problems such as thin skin, sensory deficits, loose skin, fragile veins and short-term memory deficits
  • The INS doesn’t distinguish between available devices; but one particular device, STATLOCK® Stabilization Device, is cited in all the studies in the INS bibliography on catheter stabilization

New Standards for Improving Peripheral IV Catheter Securement

Bonnie Smith and Timothy Royer, Nursing 2007, Vol. 37, No. 3, pg. 72-73.

  • Peripheral IV
  • 3 arm, nonrandomized observational study of tape, HubGuard®, and STATLOCK® Stabilization Device
  • Outcome measure: percent of IVs surviving for 96 hours
  • n = 73 with tape
  • n = 286 with STATLOCK® IV Ultra Stabilization Device (phase 1 and phase 2)
  • n = 300 with HubGuard®
  • 96 hour IV protocol
  • Observed rates:
  • 8% PIV survival rate with tape
  • 9% survival rate with HubGuard®
  • 52% PIV survival rate with STATLOCK® IV Ultra Stabilization Device
  • P < .001 STATLOCK® Device vs. tape or HubGuard®

How to Secure a Peripheral IV Catheter

Bonnie Trottier, Infection Control Today, February 2005, Vol. 9, No. 2.

  • Tape inadequacies can lead to complications such as phlebitis, infiltration, migration and dislodgement that cause patient discomfort and harm
  • Frequent IV restarts consume time that nurses really don’t have due to their patient care and paperwork responsibilities
  • The precision engineered securement device (STATLOCK® IV Ultra Stabilization Device) also proved fast and easy to apply
  • Follow the methods that work best: Prep, Press, Peel and Place, followed by Dissolve and Disengage

STATLOCK® PICC Stabilization Device

Achieving Zero Catheter Related Blood Stream Infections: 15 Months Success in a Community Based Medical Center

Sophie A. Harnage, The Journal of the Association for Vascular Access (JAVA), 2007, Vol. 12, No. 4; pg. 218-225.

  • Sutter Roseville Medical Center
  • 32 critical care beds
  • PICC team
  • Retrospective study of CRBSI before and after implementation of a central line bundle
  • Lowered complications and improved patient outcomes through central line bundling, focused nursing practice and product technologies, including consistent use of the STATLOCK® PICC Plus Stabilization Device

A Comparative Retrospective Analysis of Two Securement Techniques for Peripherally Inserted Central Catheters (PICC) and Midlines in the Homecare Setting

Diana Wood and Leigh Ann Bowe-Geddes, Journal of Vascular Access Devices, Fall 1997, Vol. 2, No. 3, pg. 1-6.

  • Homecare
  • PICC
  • Home infusion therapy providers in Kentucky and Pennsylvania
  • STATLOCK® PICC Plus Stabilization Device, Steri-Strips® and tape
  • 178 patient charts equaling 5,347 days of therapy
  • 10.7/1,000 catheter days therapy discontinuation due to complications in control group
  • 2.18/1,000 catheter days therapy discontinuation due to complications in study group
  • (STATLOCK® PICC Plus Stabilization Device)
  • 14.86/1,000 catheter days unscheduled nursing visits in the control group
  • 3.55/1,000 catheter days unscheduled nursing visits in the study group (STATLOCK® PICC Plus Stabilization Device)
  • Three-fold decrease in dislodgement with STATLOCK® PICC Plus Stabilization Device
  • Reduction in overall incidence of complications P < 0.05

Other resources:

Catheter Stabilization Devices Are Becoming Standard of Care; Gregory Schears, M.D., American Society of Anesthesiologists, June 2007, Vol. 71, No. 6.
Caring for a Nontunneled CVC Site; Lynn Hadaway, Nursing, 2005, December, Vol. 35, No. 12, pg. 54-56.

STATLOCK® Arterial Stabilization Device

The Advantages of a Precision-Engineered Securement Device for Fixation of Arterial Pressure-Monitoring Catheters

Catherine Stephenson, The Journal of the Association for Vascular Access (JAVA), 2005, Vol. 10, No. 3, pg. 1-3.

  • Prospective, nonrandomized, sequential, observational study
  • Bay Medical Center, Panama City, FL
  • 468 arterial catheters secured with STATLOCK® Arterial Select Stabilization Device
  • 995 arterial catheters secured with the protocol during control period
  • 20-g radial artery catheters
  • Immobilized wrist with adult arm board
  • 25% restart rate with tape and transparent membrane dressing
  • 12.8% restart rate with study device (STATLOCK® Arterial Select Stabilization Device)
  • Representing 48.8% reduction in unscheduled arterial catheter restarts
  • P < .001
  • STATLOCK® Arterial Select Stabilization Device usage was essentially cost neutral
  • The device allowed for a securement procedure that complies with CDC guidelines and conforms to OSHA requirements

Ancillary

Evaluation of a Visual Infusion Phlebitis Scale for Determining Appropriate Discontinuation of Peripheral Intravenous Catheters

Paulette Gallant, Journal of Infusion Nursing, November/December 2006, Vol. 29, No. 6, pg. 338-345.

  • 851 PIV catheters and 513 patients
  • Prospective, nonrandomized, sequential, observational study
  • Financial cost of inserting a new PIV catheter is estimated at $25 in author’s facility, not including patient suffering and nurse time
  • When PIV catheters are restarted, the risk of phlebitis is 4.4 times higher than when PIV was not restarted

The 4-1-1 on New Infusion Nursing Standards of Practice

Lynn Hadaway, Infection Control Today, June 2006.

  • Interview format on INS Standards of Practice
  • The standards are intended to promote positive patient outcomes and reduce the risk of unnecessary trauma or complications, assist the nursing profession by reducing risk of malpractice claims, and assist manufacturers by reducing risk of product liability claims
  • OSHA mandates to review catheter securement, annually, as part of an exposure control plan
  • Nonsterile tape, suture and site dressings are no longer considered adequate for catheter stabilization
  • The practice criteria state that if for some reason suture is initially used for stabilization, then it should be replaced with a manufactured device when the sutures become loose or are no longer intact

Needlestick Injuries Among Surgeons in Training

M.A. Makary, The New England Journal of Medicine, Vol. 356, No. 26, pg. 2693-2699.

  • Needlestick injuries are common among surgeons in training and are often not reported
  • 52% of 578 respondents received a needlestick during suturing
  • A total of 297 respondents (51%) did not report an injury to an employee health service

Influencing Product Evaluation With Hard-Hitting Evidence

Jeannie Akridge, Healthcare Purchasing News, July 2007, Vol. 31, No. 7.

  • New clinical products should be thoroughly evaluated by a multidisciplinary team and be proved to be safe, contribute to good patient outcomes, and be cost effective
  • Clinical product evaluation criteria include: indication, ease of use, clinical advantages, additional components, single vs. reusable, sterilization, vendor support, service after purchase

OSHA Fact Sheet – Securing Medical Catheters

OSHA, U.S. Department of Labor, August 2004. http://www.jointcommission.org/patientsafety

  • The process of suturing devices presents needlestick hazards
  • Engineering controls, such as improved adhesive products and securement devices, may decrease or eliminate the need for sutures and thus directly reduce needlestick risk
  • OSHA (29 CFR 1910.1030) requires that employers of workers with occupational exposure to blood or other potentially infectious materials annually consider and implement appropriate, available and effective safer medical devices designed to eliminate or minimize that exposure

CDC’s Seven Healthcare Safety Challenges

CDC, July 11, 2003. http://www.cdc.gov/ncidod/dhqp/about_challenges.html

  • Challenge 1: reduce catheter-associated adverse events by 50% among patients in healthcare settings
  • Challenge 6: eliminate occupational needlestick injuries among healthcare personnel

ECRI: OSHA Requires Annual Review of Catheter-Securement Devices

October 1, 2004.

  • OSHA specifies that healthcare facilities are required to annually review options for securing medical catheters and to consider appropriate catheters securement engineering controls as part of their annual review of methods to reduce needlestick injuries

Other resources:

Infiltration and Extravasation: Preventing a Complication of IV Catheterization; Lynn Hadaway, American Journal of Nursing, August 2007, Vol. 107, No. 8, pg. 64-72.
Suture-Free Alternatives: New Approaches to Reduce the Risk of Suture Needle Injuries; Jaime Ritter, MPH, CIC, Managing Infection Control, December 2008.
Cost Containment and Infusion Services; Kathy Kokotis, Supplement to Journal of Infusion Nursing, May/June2005, Vol. 28, No. 3S, pg. S22:S32.