Summary of Test Data 1998
Independent laboratories conducted the following tests to ensure the safety and effectiveness of Hand Sense.
* FHSA Primary Eye Irritation Test Report #X7D114
- Study Method: Hand Sense was placed in the conjunctivae sac of the right eye of test New Zealand White rabbits. Over a 72-hour period the animals were observed for mortality, signs of ill health or adverse reaction to the test material.
- Results: All animals remained healthy throughout the study period.
- Conclusion: The test material (Hand Sense) did not elicit an adverse ocular response in terms of corneal ulceration or lens opacity. The iris was normal. At 48 hours only slight redness of the conjuuctivae persisted in one rabbit. At 72 hours all scores reverted to normal.
* EBSA Acute Oral Toxicity Test Report #X701 Report #952895
- Study Method: Ten Wistar rats (five males, five females) were used in the study. An oral dose of 2ml/Kg per animal was administered to each animal on April20, 1995. Animals were observed for any signs of morbidity or mortality through May 5, 1995. They were also observed for changes in appearance, altered feeding habits, weight loss and/or signs of physical or behavioral distress.
- Conclusion: All test animals remained healthy throughout the duration of the study. No gross abnormalities were observed in any of the test or control animals. No adverse reaction to on! ingestion of the barrier cream was noted.
*Agar Overlay Test Report #108006
- Study Method: The agar overlay test was used to evaluate the cytotoxicity of diffusible components from materials or solutions on cell culture monolayers of mouse embryo fibroblast cells (clone L-929). The agar layer served as a cushion against mechanical cell damage. Samples were then incubated. Positive and negative reference controls were included with each assay. All tests were performed using three test wells per sample. Cells were examined microscopically using the following evaluation criteria: 0 = no detectable zone around or under the sample. 1= Some malformed or degenerate cells. 2 = Zone limited to area under the sample. 3 = Zone extends 0.5cm to 1.0cm beyond sample. 4 = Zone greater than 1cm in extension from the sample but not involving the entire well.
- Conclusion: The results from the three wells were average to give an average cytotoxicity score of 1 to 2.
* Guthrie Research Institute Fingerprint Assay for Latex Protein. D.Beezhold (1997)
- Study Purpose: It has been shown that emollient creams can remain on the surface of the skin and can increase the amount of allergenic proteins transferred to the skin of a glove wearer. This study was undertaken to determine if Hand Sense increased the transfer of protein to the skin.
- Study Method: The qualitative assay is a visual assessment of the amount of latex protein, which transfers from a natural rubber latex glove to the finger of the wearer. The Fingerprint assay was performed using Hand Sense cream in 1997. After wearing gloves for five minutes, the bare finger of test subjects was pressed to a nitrocellulose membrane for three seconds. The Fingerprint was repeated a total of 4 times, starting at the bottom of the membrane and working toward the top. The membrane was blocked, reacted with 1/2000 dilution of rabbit anti-latex protein antiserum. After washing, the blot was reacted with alkaline phosphatase labeled antirabbit IgG.
- Conclusion: The intensity of the immunoreactive fingerprints indicated that the amount of protein transferred from the glove to the wearer was no different with the cream than without the cream. It indicated that Hand Sense cream did not increase the transfer of latex protein to the skin.
* Randomized Trial of Novel Barrier Cream Amongst Health Care Workers, University of Wisconsin Hospitals and Clinics. D. Maki and R. McCormick (1997)
- Study Method: 57 Health Care Workers with clinical symptoms of contact dermatitis, allergic contact dermatitis and/or full thickness lesions entered into a two month randomized blinded trial. Subjects in the crossover study utilized an oil containing lotion for two weeks or Hand Sense skin protective cream. The products were applied five times daily. At the end of two weeks, subjects switched products (blinded crossover).
- Conclusion: During the study period, no adverse reactions were noted among study subjects, including those with full thickness lesions. Subjects continued their normal clinical duties (band washing, antimicrobial and detergent exposure, glove wearing, etc...). This prospective trial confirmed that Hand Sense protected the hands of workers against drying and chemical irritation. It showed substantial improvement in skin health among affected workers, particularly in those workers presenting with scaling, cracking, redness and pain. It confirmed the benefits of good hand hygiene together with the use of a skin protective cream for daily use.
* Nuclear Medicine Study with Tc99m. Negev Department of Nuclear Medicine. Beer Sheva, Israel
- Study Purpose: Accidental skin contact with I-125 and I=131 may occur in the radioisotope laboratory during the normal workday. Because absorption of radioactive material places workers at risk, a study was undertaken at the University to determine if Hand Sense provided skin protection against radioiodine exposure.
Study Method: 5 persons who were using Tc99m on a daily basis tested the cream for 6 months. In the production lab 8 persons conducted the experiment for 18 months. All participants used the cream on alternate months. A portable Geiger Counter for Tc99m with a RAM DA detector capable of detecting 3.7Bq for radioiodines measured contamination levels.
- Results: In all cases where no cream was used and an accidental Tc99m contamination had occurred the isotope could not be removed even partially by washing. When Hand Sense was applied prior to contact, complete removal of Tc99m was registered. In 20 cases of accidental radioiodine contamination the hands were completed cleaned with 1 to 3 washings in all cases. Conversely, in 19 cases of Tc99m contamination when Hand Sense was not used, the radioisotope could not be removed with detergent and water.
- Conclusion: The results of the study strongly indicate that the use of an additional protective layer supplied by Hand Sense is highly recommended for Nuclear Medicine staff working with Technetium. The layer formed by the barrier cream seemed to prevent adherence of the pertechnetate to the skin.
*Occupational Skin Exposure to Industrial Materials. Dr. Aaron Fink, Chief of Laboratories, Kaplan Hospital Israel
- Study Purpose: To determine the level of protection afforded by a barrier cream (Hand Sense) against direct skin contact with various industrial chemicals and substances.
o Study Methods: After applying Hand Sense, 0.2 ml of the test material was applied directly to the hands of 20 test subjects (13 men and 7 women). Test chemicals included: Sulfuric Acid (H2S04), 13%, 49% and 97%; Hydrochloric Acid (HCL), 11%, 19% and 37%; caustic material (NaOH), 13%, 20% and 40%, detergents, cleaning materials and soaps; turpentine Xylene, Toluene and solvents. Application of materials and hand washing events were repeated several times. Hands were examined after each contact for evidence of erythema, surface damage and physical change.
- Conclusion: Hand Sense appeared to prevent penetration of liquid into the human skin. It protected test subjects against test materials. The hands of test subjects sustained no damage, despite contact with and exposure to corrosive materials. Continuous protection was afforded test subjects up to five hours, despite 3 washing during each test. No after effects were detected in subjects, neither on hands nor any other part of the body of those
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Summary of Test Data