3M Launches Skin and Nasal Antiseptic for Preoperative Use

Addressing the rising concern about surgical site infections caused by Staphylococcus aureus (S. aureus), including methicillin-resistant Staphylococcus aureus (MRSA), 3M today announced the launch of the 3M™ Skin and Nasal Antiseptic (Povidone-Iodine Solution 5 percent w/w (0.5 percent available iodine) USP) Patient Preoperative Skin Preparation.

This is the first product designed to reduce S. aureus in the nasal passages or nares, and is applied in the healthcare setting prior to surgery. Clinical studies show that the antiseptic kills 99.5 percent of S. aureus in the nares in one hour and maintains that level for at least 12 hours, an important benefit for patients undergoing surgery who may be at risk for infection.(1)

 “Staphylococcus aureus is the leading cause of surgical site infections with approximately 80 percent of S. aureus infections caused by the patient’s own nasal flora,” said Matt Scholz, corporate scientist with the  Infection Prevention Division at 3M.(2)  “As a patient preoperative skin preparation, 3M Skin and Nasal Antiseptic helps reduce the risk of S. aureus surgical site infection, including MRSA, which provides healthcare providers with confidence and control.” 

 According to a company-sponsored survey of 130 surgeons and infection preventionists, the pre-surgical landscape is changing rapidly.  Not only has the prevalence of MRSA resulted in an increase in screening over the last year, but healthcare professionals expect to see an increase in the use of nasal prep products in the coming five years. The new 3M Skin and Nasal Antiseptic is designed to be used in the preoperative process and should be applied an hour before surgery. The solution consists of film-forming materials that enable the active ingredient to remain in the nares and efficiently coat and adhere to mucosal tissue where bacteria reside. This is especially important because the unique physiology of the nose presents many challenges not seen on the skin. The nose works continuously to clear foreign particles and microorganisms making it difficult for antimicrobials to reach and kill bacteria.

 As the only product designed to work within the preoperative process to quickly and effectively reduce S. aureus colonization in the nares, healthcare providers can be confident their patients are entering surgery with a reduced risk of infection. Using this product won’t compromise the hospital’s antibiotic stewardship – the active ingredient is an antiseptic, and has not been shown to lead to acquired resistance. 

 A number of in vivo and in vitro studies of the 3M Skin and Nasal Antiseptic have been conducted, including:

-- Adomen and Groin Tests (in vivo):  The bactericidal effect of 3M Skin and Nasal Antiseptic on the skin of healthy subjects was assessed using the in vivo clinical method for patient preoperative skin preparations, as outlined in the FDA Tentative Final Monograph (TFM) for Health-Care Antiseptic Drug Products.  The 3M Skin and Nasal Antiseptic was applied to the abdomen and groin test sites with post-prep samples taken at 10 minutes, one hour and six hours.  Results showed that the 3M Skin and Nasal Antiseptic exceeded the TFM requirements of producing a 2-log reduction of bacteria on the abdomen and 3-log reduction on the groin at 10 minutes post-prep and kept counts below baseline at six hours.(3)

 -- Effectiveness in Nasal Flora (In vivo):  Subjects applied 3M Skin and Nasal Antiseptic or the saline control twice to each nostril for 30 seconds.  Post-prep samples from the nares were taken at one, six and 12- hours.  Results demonstrated that 3M Skin and Nasal Antiseptic killed 99.5 PERCENT of the bacteria within one hour and maintained the 99.5 PERCENT kill for at least 12- hours post-prep.  Results were statistically significant over baseline (p-value≤0.0004) and showed significantly more S. aureus reduction than the control (p-value≤0.05).(4) 

-- Safety Study:  Subjects applied either 3M Skin and Nasal Antiseptic or the saline control twice to each nostril for 30 seconds.  After 60 minutes, the nostrils of each subject were assessed for the level of erythema (redness) and edema (swelling).  Results showed little swelling or irritation, which meant that the nasal swab was considered non-irritating.(5)

“These studies affirm that the 3M Skin and Nasal Antiseptic is effective in killing high levels of bacteria both on the skin and in the nares, and maintaining that high level of reduction for at least 12 hours in the nares.  Ultimately, that reduction in bacteria may also decrease the patient’s risk for acquiring a post-operative infection from nares colonized with harmful bacteria,” said Scholz.  “The product is easy for clinicians to use and patients reported the smell, taste and amount of dripping to be acceptable.”(6)

The 3M Skin and Nasal Antiseptic is packaged in an easy-to-open 4 mL bottle with swabs.  The swabs are designed to fit comfortably into nostrils while providing good coverage of the nasal passage and nares with minimal dripping or running.

References:

 1.        3M Data on File

2.         Wertheim, HFL, et al. Risk and Outcome of Nosocomial Staphylococcus aureus Bactaeremia in Nasal Carriers versus Non-carriers. The Lancet 2004;364: 703-705.

3.         3M Data on File

4.         3M Data on File

5.         3M Data on File

6.         3M Data on File

 

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