Pre-Market Evaluation

(1)

Joseph Hommes BSN, RN, VA/BC Graham Smith Biostatistician

The clinical performance of a CHG transparent

dressing designed for use with Huber needles

(2)

Pre-Market Evaluation

• Study Period: November 2014 – January 2015

• 15 facilities from 7 states participated

• 468 patients with implanted ports were observed

• Clinicians used the 3M

^TM

Tegaderm

^TM

CHG Chlorhexidine Gluconate I.V.

Port Dressing for 2-4 weeks to provide antimicrobial protection to their port sites rather than their usual product consisting of either:

o BioPatch® + dressing (n=82)

3M

^TM

Tegaderm

^TM

CHG Chlorhexidine Gluconate I.V. Securement Dressing (n=4)

(3)

Performance Characteristics Measured

 Wear time

 Gentleness to skin

 Patient comfort

 Ease of application

 Ease of removal

 Ability to visualize site

 Skin irritation

(4)

Facility 1 Facility 2 Facility 3 Facility 4 Facility 5 Facility 6 Facility 7 Facility 8 Facility 9 Facility 10

Study Diversity

• Both single and dual port usage tested

• Hospital and OutPatient usage tested

• In Hospital, multiple units

usage tested

(5)

(6)

Evaluation Discussion

• No skin irritation or adverse events reported

• Customer Quotes:

– “This dressing feels soft and comfortable”

– “Dressing removes easier and does not stick to needle”

– “Less irritation”

– “Difficult to place BioPatch® under dual ports”

• 95.1% of evaluators preferred the 3M

^TM

Tegaderm

^TM

CHG Chlorhexidine

Gluconate I.V. Port Dressing based on overall performance when compared

(7)

References

1 American Cancer Society. Cancer Facts & Figures 2010 Tables & Figures.

http://www.cancer.org/Research/CancerFactsFigures/CancerFactsFigures/most-requested-tables-figures-2010.

2 Warren JL, Mariotto AB, Meekins A, Topor M, Brown ML. Current and future utilization of services from medical oncologists. J Clin Oncol 2008;26:3242−7.

3 Kamboj M, Sepkowitz KA. Nosocomial infections in patients with cancer. Lancet Oncol 2009;10:589−97.

4 Maschmeyer G, Haas A. The epidemiology and treatment of infections in cancer patients. Int J Antimicrob Agents 2008;31:193−7.

5 Guinan JL, McGuckin M, Nowell PC. Management of health-care−associated infections in the oncology patient.

Oncology 2003;17:415−20.