xm18C
Compares Favorably to Ostomy
Competitors
Several analytical studies were undertaken by Xennovate Medical LLC in early 2006 to validate the ostomy application advantages the Company believes its xm18 has over key competitors in the ostomy hydrocolloid skin barrier market segment. This report explains the studies and validates the moisture absorption advantages held by Xennovate Medical’s xm18C formulation versus the competitors studied. Our
premise is that
long-lasting, or continual, absorption is a good thing
for the EndUser’s skin, and our formula was created
with this in mind. In the extreme alternative, no
absorption, fluid will naturally flow into the gaps,
including under the barrier and in contact with the
EndUser’s skin leading to skin maceration.
As our objective was to highlight xm18 and not to denigrate the competition, we have chosen to blind the competitive brands for this publication by coding them with a key held internally. Separately, then, we have aggregated all of the competitive samples and created a mean value (“CompMean”) for all the competitive samples to compare to our xm18. Our success can be seen in the chart nearby comparing the performance of xm18 directly to an aggregation of all the competitors studied. The disaggregated competitive data can be found on page two. One further note regarding this graph is that the data for both curves has been smoothed using the simple mean of three adjacent data points. The first and last data points for each series are actuals.
CONCLUSION: xm18C outperforms all comparative samples studied in absorptive capacity and wet tack capabilities.
Results of the Study
The details are reflected in the data included below and related graphs following. Data points are missing for one of two reasons: 1) the sample had disintegrated by the time period reflected by the “Ø” or 2) the researcher was not available to take the measurement. As there are a few sample data points missing and as our effort was to reflect the performance of xm18 against its key competition, the better
comparisons are made
against the overall average data (“MeanAll”)
or against the collective competitive averages
(“CompMean”).
From the data we can see that the two samples that rapidly absorbed moisture above the mean within three hours of application have disintegrated by the 24-hour reading. xm18’s early absorption is less than the mean at the three hour mark, but continues to ramp up over the entire 72 timeframe, and it is still absorbing when the measurements are discontinued. Of the remaining three samples only one fails to absorb even 2 times its weight in moisture even at 72 hours, while the other two attain four and five times their weight in absorption in about 24 hours, although like all others, except xm18, they lose absorptive capacity by the time the 72 hour mark is reached; this weight loss is typically do to partial disintegration. xm18 continues to maintain its integrity and absorptive capacity even at the 72-hour mark.
Study Procedure
A test sample of each hydrocolloid under study was created. The samples were all 2 inches by 2 inches. Their thickness was a function of what the respective companies market, so you will find that the initial weights of the samples will differ. Xennovate Medical promotes the use of its ostomy skin
barrier at a thickness of 25 mils (0.635 mm) versus
the industry standard of 40 mils (~1 mm) because it
provides a lower cost to our customers based on weight
and a lower profile to the EndUser, while lasting as long
or longer than competitive brands. This study validates
this marketing claim.
Each 2x2 sample was then attached on one side to a 4x4 sheet of Mylar to maintain for as long as possible the integrity of the sample for the purpose of weighing it. Once the samples were prepared, they were subjected to full immersion (a rigorous test compared to actual applications) in a 0.9% normal saline solution for up to a maximum of 72 hours. The samples were removed from the saline bath periodically and weighed, until they were no longer viable due to complete disintegration into the wet bath. The data captured and recorded was the weight in grams of each sample. Subsequently, the weight at each time period was divided by the initial weight of the sample to enable rational comparisons across the data.
Test Conditions. All testing was carried out at a temperature of 20º C ± 1º C and 40% - 60% relative humidity.
Several analytical studies were undertaken by Xennovate Medical LLC in early 2006 to validate the ostomy application advantages the Company believes its xm18 has over key competitors in the ostomy hydrocolloid skin barrier market segment. This report explains the studies and validates the moisture absorption advantages held by Xennovate Medical’s xm18C formulation versus the competitors studied. Our
As our objective was to highlight xm18 and not to denigrate the competition, we have chosen to blind the competitive brands for this publication by coding them with a key held internally. Separately, then, we have aggregated all of the competitive samples and created a mean value (“CompMean”) for all the competitive samples to compare to our xm18. Our success can be seen in the chart nearby comparing the performance of xm18 directly to an aggregation of all the competitors studied. The disaggregated competitive data can be found on page two. One further note regarding this graph is that the data for both curves has been smoothed using the simple mean of three adjacent data points. The first and last data points for each series are actuals.
CONCLUSION: xm18C outperforms all comparative samples studied in absorptive capacity and wet tack capabilities.
Results of the Study
The details are reflected in the data included below and related graphs following. Data points are missing for one of two reasons: 1) the sample had disintegrated by the time period reflected by the “Ø” or 2) the researcher was not available to take the measurement. As there are a few sample data points missing and as our effort was to reflect the performance of xm18 against its key competition, the better
From the data we can see that the two samples that rapidly absorbed moisture above the mean within three hours of application have disintegrated by the 24-hour reading. xm18’s early absorption is less than the mean at the three hour mark, but continues to ramp up over the entire 72 timeframe, and it is still absorbing when the measurements are discontinued. Of the remaining three samples only one fails to absorb even 2 times its weight in moisture even at 72 hours, while the other two attain four and five times their weight in absorption in about 24 hours, although like all others, except xm18, they lose absorptive capacity by the time the 72 hour mark is reached; this weight loss is typically do to partial disintegration. xm18 continues to maintain its integrity and absorptive capacity even at the 72-hour mark.
Study Procedure
A test sample of each hydrocolloid under study was created. The samples were all 2 inches by 2 inches. Their thickness was a function of what the respective companies market, so you will find that the initial weights of the samples will differ. Xennovate Medical promotes the use of its ostomy skin
Each 2x2 sample was then attached on one side to a 4x4 sheet of Mylar to maintain for as long as possible the integrity of the sample for the purpose of weighing it. Once the samples were prepared, they were subjected to full immersion (a rigorous test compared to actual applications) in a 0.9% normal saline solution for up to a maximum of 72 hours. The samples were removed from the saline bath periodically and weighed, until they were no longer viable due to complete disintegration into the wet bath. The data captured and recorded was the weight in grams of each sample. Subsequently, the weight at each time period was divided by the initial weight of the sample to enable rational comparisons across the data.
Test Conditions. All testing was carried out at a temperature of 20º C ± 1º C and 40% - 60% relative humidity.