SOURCE: Gebauer Company

Gebauer Company

August 11, 2015 10:30 ET

Research Finds That Cleveland-Produced Pain Ease Does Not Increase Bacterial Growth

CLEVELAND, OH--(Marketwired - Aug 11, 2015) - A new Cleveland Clinic study has found that using pentafluoropropane/tetrafluoroethane coolant spray as a topical anesthetic does not affect the sterility of treatment sites.

Vapocoolant sprays (or skin refrigerants) -- such as Gebauer's Pain Ease® -- are often used in office settings to diminish pain caused by needle injections or minor surgical procedures.

The research, conducted by James Zins, M.D., chairman of plastic surgery at Cleveland Clinic, determined that spraying Pain Ease on patients' skin resulted in no statistically significant increase in bacteria when applied after a topical antiseptic. The study included 50 volunteers. Results were based on the application of Pain Ease to the face/cheeks after being cleansed with povidone iodine. Skin bacteria count was measured before and after administering povidone iodine and after spraying the skin refrigerant.

Pain Ease is produced by Cleveland-based Gebauer Company. The study -- funded by Gebauer -- was published in Dermatologic Surgery, the journal of the American Society for Dermatologic Surgery.

"As plastic surgeons, we are always attentive to reducing any pain or discomfort associated with the procedures we perform," said Dr. Zins, who is also a professor of plastic surgery at the Cleveland Clinic Lerner College of Medicine at Case Western Reserve University. "However, some physicians may have avoided skin refrigerants due to the lack of microbiological data."

The skin sterility results provide clinical evidence to back what Gebauer and many medical professionals already suspected -- there is no increase in pathogens on the face/cheeks after using Pain Ease. Similar findings from a study by Dr. Zins of skin cleansed with isopropyl alcohol were recently published in Aesthetic Plastic Surgery.

The findings are significant, said John Kreft, Director of Engineering and New Product Development at Gebauer. "We are steadfast in our concern and focus on safety and believe it is our obligation to prove that our products do not increase bacteria at a procedure site. Dr. Zins' study does exactly that."

Pain Ease Indications for Use:
Pain Ease instantly and temporarily controls pain associated with needle procedures (venipuncture, IV starts, cosmetic procedures, injections), minor surgical procedures (suturing, foreign body removal, incisions and drainage of small abscesses) and the temporary relief of minor sports injuries (sprains, bruising, cuts and abrasions). Pain Ease is intended for topical application to skin, intact mucous membranes and minor open wounds.

Important Risk and Safety Information for Pain Ease:
Published clinical trial results support the use in children three years of age and older. Do not use on large areas of damaged skin, puncture wounds, animal bites or serious wounds. Do not spray in eyes. Over spraying may cause frostbite. Freezing may alter skin pigmentation. Use caution when using product on diabetics or persons with poor circulation. Apply only to intact oral mucous membranes. Do not use on genital mucous membranes. The thawing process may be painful and freezing may lower resistance to infection and delay healing. If skin irritation develops, discontinue use. CAUTION: Federal law restricts this device to sale by or on the order of a licensed healthcare practitioner.