Science & Skin - Surgicept

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Science & Skin

Developed and patented by Columbia University scientists, the non-sticky formula with moisturizers helps prevent drying and leaves hands soft and smooth, so you can use Surgicept® Hand Sanitizer multiple times per day without drying.

6 Hours Proven Persistence Study

Independent laboratory1 evaluated the effectiveness of Surgicept® Hand Antiseptic (70% ethyl alcohol) compared to two traditional alcohol hand sanitizers (61% ethyl alcohol) up to six (6) hours after application.

Test Method

  1. Wash hands with soap and water.
  2. Hands were contaminated
  3. Apply product per directions for use
  4. Wait 15 minutes
  5. Culture the hands to evaluate the bacteria colony forming unit growth at time internals for six hours

Conclusion

  • Only Surgicept® Hand Antiseptic provided effectiveness up to six (6) hours post application.
  • Without sanitizing protection, bacteria started reproducing almost immediately.
  • If using a traditional hand sanitizer, consider reapplying frequently

Results

Exaggerated Hand Wash Clinical Study

The FDA outlined testing criteria for over-the-counter (OTC) Consumer Antiseptic Rub products published in the Federal Register (FR) of June 17, 1994 (Tentative Final Monograph) and subsequent Final Monograph published in Federal Register of June 30, 2016. The tests measure log reduction in colony forming units (CFU's) from baseline.

BioScience Laboratories, accredited third party testing laboratory, performed the in vitro and in vivo (human) studies per the FDA's the monograph for Surgicept® hand antiseptic labeling, with the following results:

FDA Monograph Requirement: 100 fold (2 log) reduction after wash 1 and a 1,000-fold (3 log) reduction after wash 10.

Surgicept® Results:
• Test subjects started with a mean baseline of 9.07 log10 (1.174 billion bacterial count)
• After Wash 1, a 4.91 log reduction reducing the mean bacterial count 10,000-fold or (>99.99%) from baseline.

• After Wash 10, a 5.94 log reduction reducing the mean bacterial count 100,000-fold or (>99.999%) from baseline.



Conclusion:
Surgicept® hand antiseptic meets and exceeds the FDA's OTC Monograph criteria for hand antiseptic labeling.

Log Reduction from Baseline Testing

Virus Testing

Additional in vitro testing was performed to determine Surgicept®'s efficacy against 6 well known enveloped and nonenveloped viruses:

• Swine-like H1N1 influenza A virus strain
• Avian influenza
• Bovine viral diarrhea virus
• Herpes simplex virus (surrogate for hepatitis C virus)
• Human immunodeficiency virus type 1
• Respiratory syncytial virus

Results

Skin Friendliness Study

Surgicept’s patented medical grade formula was designed for repeated use without drying out the hands. The smart formula includes 6 moisturizers, emollients and skin conditioners to counteract the drying effects of alcohol.

Test: 68 subjects applied Surgicept® 25 times per day after 4 days.

Results: of the 68 subjects tested, no significant difference in skin hydration, values between baseline |before repeted exposire| and after exposure.

Skin Damage Potential Study

Healthcare professionals must apply a hand antiseptic between each patient contact requiring numerous applications per day potentially resulting in skin damage. Surgicept® hand antiseptic was tested to determinate the skin damage potential after repeated applications over an extended period.

No significant difference in skin hydration

Test results performed by BioScience Laboratiories, 2011

Premium Quality Moisturizing Ingredients

Surgicept is smart, patented formulation combining 6moisturizers, emollients and skin conditioners to counteract the drying from repeated alcohol use and leave the hands feeling soft and smooth. The unique blend of skin conditioning ingredients used in premium quality lotions and skin related products.

Tegosoft® APM
Very high polar cosmetic oil.

PPG-3 Myristyl Ether
Coscmetic oil with solubilizing properties, especially suitable for transparent deodorant/antiperspirant sticks.

Sensiva® SC50
Multifunctional cosmetic ingredient

Ethylhexylglycerin
Emolient derived from glycerin and comonly found in soaps, shampoos, and conditioners to improve skin feel.


Polyquaterinum-10
Premium quality emollient that creates a smooth feeling on the surface white conditioning the skin. Used in cosmetics and personal care products, primarily for hair care, lotions and makeup.

IncroquatTM Behenyl TMS-50
(Vegetable derived)

Ethylhexylglycerin
Formulation created by Croda, Inc.combining Behentrimonium methosulfate, Butylene Glycol and Cetyl Alcohol to create a premium quality skin conditioner used in cosmetic dermatology products.

Behentrimonium methosulfate

Butylene Glycol
Bonds with water molecules to increase the water content in the skin itself.

Cetyl Alcohol
Emollient derived from vegetable oils suchs as palm or coconut oil. Used primarily in creams and lotions.

Trademarks are the respective property of the following with all rights reserved. Tegosoft is a registered trademark of Evonik Industries AG (Germany). Sensiva is a registered trademark of SchÜlke, Inc. (SchÜlke & Mayr GmbH, Germany). Incroquat is a trademark of Croda, Inc.

Reference Materials

· Cargill, Innes D. PhD, et al., Development of a health care personnel handwash with 6-hour persistence, American Journal of Infection Control, 2011, Vol 39 No. 3, 226-234. · https://www.ajicjournal.org/article/S0196-6553%2811%2900104-0/abstract
· https://pubmed.ncbi.nlm.nih.gov/21458685/
· Gaonkar, T.A., Geraldo, I., et al., In vivo efficacy of an alcohol-based surgical hand disinfectant containing a synergistic combination of ethylhexglycerin and preservatives,
American Journal of Infection Control, 2006, 63, 412-417
· https://pubmed.ncbi.nlm.nih.gov/16759740/
· Modak, S., PhD., Cayci, C. PhD, Seal, L. PhD. Columbia University, Dept of Surgery, College of Physicians and Surgeons, New York City, NY. Low Adherence with Waterless
Surgical Hand Antisepsis. Association of Operating Room Nurses Clinical Poster. 2005, March. (pdf enclosed, make it a pop-up)
FDA Monograph for Consumer Antiseptic Rubs https://www.federalregister.gov/doents/2019/04/12/2019-06791 safety-and-effectiveness-of-consumer-antiseptic-rubs-top
cal-antimicrobial-drug-products-for
· CDC Recommended Application Process for Alcohol Hand Sanitizers https://www.cdc.gov/handwashing/hand-sanitizer-use.html#:~
text=based Hand Sanitizer-,Use an alcohol Dbaedz hand sanitizer that contaz at least,hands to cover all surfaces
· CDC Handwashing Guidelines. https://www.cdc.gov/handwashing/when-how-handwashing.html
https://healthmanagement.org/c/imaging/news/3-step-15sec-hand-rubs-reduce-infection-improve-hygiene-compliance

Microorganism Log Reduction Reference Table