Development of in vitro methods to model the impact of vaginal lactobacilli on Staphylococcus aureus biofilm formation on menstrual cups as well as validation of recommended cleaning directions.

Introduction: Menstrual cups (MC) are a reusable feminine hygiene product. A recent publication suggested that Staphylococcus aureus (S. aureus) biofilms can form on MCs which may lead to increased risk of menstrual Toxic Shock Syndrome (mTSS). Additionally, there is concern that buildup of residual menses may contribute to microbial growth and biofilm formation further increasing mTSS risk. Quantitative and qualitative analysis of in vitro tests were utilized to determine if S. aureus biofilm could form on MC in the presence of the keystone species Lactobacillus after 12 h of incubation. The methodology was based on a modification of an anaerobic in vitro method that harnesses the keystone species hypothesis by including a representative of vaginal lactic acid bacteria. Methods: MCs were incubated anaerobically for 12 h in Vaginal Defined Media (VDM) with the two morphologically distinct bacteria, Lactobacillus gasseri (L. gasseri) and S. aureus. Colony Forming Units (CFU) for each organism from the VDM broth and sonicated MC were estimated. In addition, a separate experiment was conducted where S. aureus was grown for 12 h in the absence of L. gasseri. Qualitative analysis for biofilm formation utilized micro-CT (µ-CT) and cryogenic scanning electron microscopy (Cryo-SEM). Results: Samples collected from the media control had expected growth of both organisms after 12 h of incubation. Samples collected from VDM broth were similar to media control at the end of the 12-h study. Total S. aureus cell density on MC following sonication/rinsing was minimal. Results when using a monoculture of S. aureus demonstrated that there was a significant growth of the organism in the media control and broth as well as the sonicated cups indicating that the presence of L. gasseri was important for controlling growth and adherence of S. aureus. Few rod-shaped bacteria (L. gasseri) and cocci (S. aureus) could be identified on the MCs when grown in a dual species culture inoculum and no biofilm was noted via µ-CT and cryo-SEM. Additionally, efforts to model and understand the validity of the current labeled recommendations for MC cleaning in-between uses are supported. Discussion: The data support continued safe use of the Tampax® cup when used and maintained as recommended.

The safety assessment of tampons: illustration of a comprehensive approach for four different products.

Introduction: We illustrate a comprehensive tampon safety assessment approach that assures products can be used safely. Material biocompatibility, vaginal mucosa assessment, vaginal microbiome evaluation, and in vitro assessment of potential risk of staphylococcal toxic shock syndrome expressed through growth of Staphylococcus aureus (S. aureus) and production of TSST-1 are the four essential portions of the approach. Post-marketing surveillance informs of possible health effects that warrant follow up. The approach meets or exceeds US and international regulatory guidance and is described through the example of four tampon products. Methods/Results: Each product is comprised mostly of large molecular weight components (cotton, rayon, polymers) that cannot pass the vaginal mucosa, are widely used across the industry, and replete with a vast body of safety data and a long history of safe use in the category. Quantitative risk assessment of all small molecular weight components assured a sufficient margin of safety supporting their use. Vaginal mucosa assessment confirmed that pressure points, rough edges and/or sharp contact points were absent. A randomized cross-over clinical trial (ClinicalTrials.gov Identifier: NCT03478371) revealed favorable comfort ratings, and few complaints of irritation, burning, stinging, or discomfort upon insertion, wear, and removal. Adverse events were few, mild in severity, self-limited and resolved without treatment. Vaginal microbiota assessment in vitro presented no adverse effect on microbial growth. Culture-independent microbiome analyses from vaginal swab samples obtained during the clinical trial showed no differences attributable to tampon usage, but instead due to statistically significant subject-to-subject variability. Growth of S. aureus and TSST-1 toxin production in the presence of any of the four products in vitro were statistically significantly reduced when compared to medium control alone. Discussion: The data from the four elements of the comprehensive safety assessment approach illustrated herein confirm that tampons evaluated using this system can be used safely for menstrual protection. A post-marketing surveillance system that monitors and responds to in-market experiences indicated in-use tolerability of the product among consumers, thus confirming the conclusions of the pre-marketing safety assessment.

From theory to practice: a novel meditation program at a global corporation.

Global levels of stress, worry, sadness, and anger hit new highs in recent years, and employee well-being has been identified as a necessary focus in occupational health. Developed over 6 years in a large multi-national company, the Meditation Without Expectations™ 8-week course evolved from theories to practice. The intervention teaches 8 meditation techniques in a specific order and incorporates health coaching and adult learning principles that drive impact. The wellbeing program was offered using a virtual online platform to employees in more than 30 countries during 2021-22. Its effectiveness was evaluated using established standard questions and cutting-edge consumer research methods. The descriptive study uses quantitative and qualitative analyses from more than a thousand employees. Paired t-tests are used to compare pre- and post-course survey scores. The test subjects who completed the 8-week course had significant improvements (p < 0.0001) across genders, geographies, and durations of employment, and in all measured domains of stress, mindfulness, resiliency, and empathy, whereas the comparison group did not. Advanced topics analysis is used to extract common learning objectives from unstructured text submitted by enrolled employees, which helped focus the intervention on what people need or want to learn. A proprietary artificial intelligence model is used to classify subjects' comments after completing the course, finding highly positive outcomes with potential for new habit creation due to a mental model change. A framework of characteristics that make the intervention impactful is also shared.

Improving newborn skin health: Effects of diaper care regimens on skin pH and erythema.

BACKGROUND/OBJECTIVE: Newborn infant skin is functional but immature, and diapering products can play a significant role in infant diapered skin health. Previous work demonstrated a regimen consisting of a diaper with an emollient and apertures on the inner liner (topsheet) with an acidic, pH-buffered wipe (Regimen A) lowered newborn skin pH and reduced the enzymatic activity on skin post-stool cleaning versus a regimen without these features (Regimen B). This study extends these findings to determine the impact of Regimen A on diaper area erythema severity over a 2-week use period. METHODS: This IRB-approved, blinded, randomized, crossover study enrolled newborn infants >7 days and ≤8 weeks. Participants exclusively used two unique diaper and wipe combinations, Regimen A and Regimen B (non-emollient, non-aperture containing topsheet and wipe with limited buffering capacity), each for 14 days and preceded by a 3-day washout regimen. RESULTS: Diapered skin pH was reduced during Regimen A use to values similar to that of a non-diapered control site (chest), while use of Regimen B was associated with a more alkaline skin pH. Regimen A resulted in significantly fewer severe erythema episodes. At the site of highest erythema, the perianal space, the average erythema score was significantly lower and more newborns were free of erythema while using Regimen A vs. Regimen B (P < .05). CONCLUSIONS: These findings demonstrate that diapering products can have a significant impact on newborn skin. They reinforce the need to support the physiological normalization of skin pH and protection from skin irritation and damage.

Use of an emollient-containing diaper and pH-buffered wipe regimen restores skin pH and reduces residual enzymatic activity.

BACKGROUND/OBJECTIVES: Diaper dermatitis is one of the most frequent skin conditions affecting infants and is associated with elevated skin pH, exposure to urine and feces, and increased fecal protease and lipase activity, resulting in stratum corneum barrier damage and increased risk of infection. The study aim was to determine the impact of two diaper and wipe regimens on newborn infant skin pH and residual enzyme activity after stool cleaning. METHODS: Two diaper and wipe regimens were compared in a randomized, single-blinded crossover study. Regimen A paired an emollient-containing diaper with an acidic, pH-buffered wipe. Regimen B was a non-emollient diaper and wipe with limited buffering capacity. A 3-day washout period preceded each 3-day regimen use period. Skin pH at the perianal/buttocks interface (PBI), genital region, and undiapered chest control were measured at baseline and day 3. Skin swabs were collected for residual enzyme activity after a stool cleaning event. RESULTS: Diapered skin pH at the PBI was similar to undiapered skin after 3 days of use for Regimen A, while PBI pH for Regimen B was elevated versus control. PBI pH was lower for Regimen A versus Regimen B. After a stool cleaning, PBI skin pH for Regimen A was lower immediately and had lower residual enzyme activity versus Regimen B (P < .05), and the pH-lowering effect was sustained up to 60 minutes. CONCLUSIONS: These results suggest that the use of an emollient-containing diaper with a pH-buffered wipe creates conditions favorable to optimum diapered skin health.

Impact of Advertising on Tampon Wear-time Practices.

OBJECTIVES: (1) To determine whether advertising nighttime tampon use for up to eight hours was understood to be consistent with label recommendations and (2) to determine whether television and print advertising with this message affected tampon wear times in adults and teens. METHODS: (1) A comprehension study (online advertising and follow-up questionnaire) among women aged 14-49 years (300 per group) who viewed either the test or a control advertising message; (2) Diary-based surveys of tampon wear times performed prior to (n = 292 adults, 18-49 years, 74 teens, 12-17 years) and after (n = 287 adults, 104 teens) the launch of national advertising. RESULTS: Significantly more test message viewers than controls stated tampons should be worn less than or equal to eight hours (93.6% vs. 88.6%, respectively, P = 0.049). A directionally higher percentage of test message viewers said they would use a pad if sleeping longer than eight hours (52% vs. 42% of controls). Among the women who used tampons longer than eight hours when sleeping, 52% reported they would wake up and change compared with 45% of controls. No significant difference between baseline and follow-up diary surveys was found among teens or adults in various measures of tampon wear time (mean wear times; usage intervals from less than two hours to more than 10 hours; percentage of tampons used for more than or equal to eight hours; frequency of wearing at least one tampon more than eight hours). CONCLUSIONS: Advertising nighttime tampon wear for up to eight hours effectively communicated label recommendations but did not alter tampon wear times. The informational intervention had limited impact on established habits.

Randomized clinical trial comparing whitening strips, paint-on gel and negative control.

PURPOSE: To evaluate efficacy and safety of peroxide-containing whitening strips and a paint-on gel relative to a non-peroxide experimental control. METHODS: After informed consent, 52 healthy adults in Shanghai, China were randomized to one of three treatment groups: 6% hydrogen peroxide whitening strips (Crest Whitestrips), 5.9% hydrogen peroxide paint-on gel (Colgate Simply White), or water rinse which served as a negative experimental control. Strip use was twice daily over 7 days, while the paint-on gel and rinse were used twice daily over 14 days. Efficacy was measured from standard digital images of the maxillary anterior teeth, and safety was assessed from interview and intraoral examination. RESULTS: Whitening strips provided the greatest end-of-treatment reduction in yellowness (Deltab*), with adjusted means +/- standard errors of -1.72 +/- 0.18 for the strip group, -0.48 +/- 0.10 for the paint-on gel group, and 0.13 +/- 0.09 for the water rinse group. For DeltaL* (lightness), end-of-treatment adjusted means +/- standard errors were 1.88 +/- 0.21 for the strip group, 0.60 +/- 0.15 for the paint-on gel, and -0.10 +/- 0.18 for the negative control. Groups differed significantly (P< 0.007) with respect to Deltab* and DeltaL* at end-of-treatment, as well as other color parameters. All treatments were well-tolerated.