xm18
absorbs over twice the competitive mean after 72 hours
...And continues absorbing!
Several analytical studies were undertaken by Xennovate Medical LLC in early 2006 to validate the wound dressing application advantages the Company believes its xm18 has over key competitors in the moist wound healing hydrocolloid skin barrier market segment. This report explains the studies and validates the occlusive, moisture absorption advantages held
by Xennovate
Medical’s xm18
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. As our objective was to highlight
xm18,
while avoiding the denigration 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 a competitive
aggregate (“CompMean”) of the studied
samples. The disaggregated competitive data can be found
on page two.
Study Conclusion
As you will find upon review of the data and results, Xennovate Medical’s xm18 wins this competitive comparison hands down. At the end of 72 hours, with the samples totally submersed in saline solution, only xm18 has not dissolved and, in fact, continues absorbing; its absorptive uptake at 72-hours is twice the next closest competitive sample. All but one of the competitive samples has broken down completely, thereby running the risk of absorption by the wound of harmful hydrocolloid components, which “…may cause deep-seated, unresolved inflammation in tissue that appears otherwise healed.”1
Competitive samples utilized for this study include...
• Bertek’s Hydrocol®
• Convatec’s DuoDerm Signal®
• CVS & Meijer (Private branded for retail outlets)
• Dr. Scholl’s Spenco®
• Dumex’ Primacol®
• Euromed’s Sure Skin® II
• Hollister’s Restore® CX
Study Results
The most meaningful comparisons are made against the collective competitive averages (“CompMean”); see data and charts nearby. From the data representing the percent by weight absorbed, we can see that the y35 sample exceeds xm18’s absorptive capacity in the first 12 hours, but begins falling shortly thereafter; this is not practical in the clinical setting. The key word here is falling, because that performance clearly represents a breakdown in the sample. Breakdown means that absorbent
components of the
hydrocolloid are dissolving and are potentially retained
in the wound. From the medical literature, we know that
histologic evaluations of apparently healed wounds in
humans and animals have indicated deep-seated foreign
body reactions and granulomata
formations2,3 even when using Duoderm CGF (Convatec)
and Restore (Holliser), Hollister’s Restore being
the worst in the Chakravarthy study; their compounds
demonstrated a definite delay in wound
closure.1 [These are direct references found in
the footed articles]
Virtually every sample other than xm18, except z15, reaches a peak and then begins falling within the 72-hour period under observation. Of course, z15 has totally disintegrated within 24 hours (as have three other samples), so it is not a real exception, after all.
Study Procedure
A test sample of each hydrocolloid under study was created. The samples were all two inches by two 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 wound hydrocolloid
at a thickness of
15 mils (0.381 mm) versus the industry standard of 20+
mils (~1/2 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, if a backing film was not already present, to maintain the integrity of the sample for as long as possible and for 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 researcher captured and recorded the weight in grams of each sample as indicated. Subsequently, the weight at each time period was divided by the initial weight of the sample to enable rational comparisons across the data. The data for both curves has been smoothed (blue data points), where data points were missing, using a simple adjacent mean calculation.
REFERERENCES
1 D.Chakravarthy, Evaluation of three new hydrocolloid dressings: Retention of dressing integrity and biodegradability of absorbent components attenuate inflammation” J Biomedical Materials Res, Vol.28, 1165-1173 (1994)
2 P. Rosseau and R.M. Niecestro, “Comparison of the physiochemical properties of various hydrocolloid dressings,” Wounds, 3, 43-48 (1991)
3 M.D. Leek and Y.M. Barlow, “Tissue reactions induced by hydrocolloid wound dressings,” J. Anat.,180, 545-551 (1992)
Several analytical studies were undertaken by Xennovate Medical LLC in early 2006 to validate the wound dressing application advantages the Company believes its xm18 has over key competitors in the moist wound healing hydrocolloid skin barrier market segment. This report explains the studies and validates the occlusive, moisture absorption advantages held
Study Conclusion
As you will find upon review of the data and results, Xennovate Medical’s xm18 wins this competitive comparison hands down. At the end of 72 hours, with the samples totally submersed in saline solution, only xm18 has not dissolved and, in fact, continues absorbing; its absorptive uptake at 72-hours is twice the next closest competitive sample. All but one of the competitive samples has broken down completely, thereby running the risk of absorption by the wound of harmful hydrocolloid components, which “…may cause deep-seated, unresolved inflammation in tissue that appears otherwise healed.”1
Competitive samples utilized for this study include...
• Bertek’s Hydrocol®
• Convatec’s DuoDerm Signal®
• CVS & Meijer (Private branded for retail outlets)
• Dr. Scholl’s Spenco®
• Dumex’ Primacol®
• Euromed’s Sure Skin® II
• Hollister’s Restore® CX
Study Results
The most meaningful comparisons are made against the collective competitive averages (“CompMean”); see data and charts nearby. From the data representing the percent by weight absorbed, we can see that the y35 sample exceeds xm18’s absorptive capacity in the first 12 hours, but begins falling shortly thereafter; this is not practical in the clinical setting. The key word here is falling, because that performance clearly represents a breakdown in the sample. Breakdown means that absorbent
Virtually every sample other than xm18, except z15, reaches a peak and then begins falling within the 72-hour period under observation. Of course, z15 has totally disintegrated within 24 hours (as have three other samples), so it is not a real exception, after all.
Study Procedure
A test sample of each hydrocolloid under study was created. The samples were all two inches by two 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 wound hydrocolloid
Each 2x2 sample was then attached on one side to a 4x4 sheet of Mylar, if a backing film was not already present, to maintain the integrity of the sample for as long as possible and for 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 researcher captured and recorded the weight in grams of each sample as indicated. Subsequently, the weight at each time period was divided by the initial weight of the sample to enable rational comparisons across the data. The data for both curves has been smoothed (blue data points), where data points were missing, using a simple adjacent mean calculation.
REFERERENCES
1 D.Chakravarthy, Evaluation of three new hydrocolloid dressings: Retention of dressing integrity and biodegradability of absorbent components attenuate inflammation” J Biomedical Materials Res, Vol.28, 1165-1173 (1994)
2 P. Rosseau and R.M. Niecestro, “Comparison of the physiochemical properties of various hydrocolloid dressings,” Wounds, 3, 43-48 (1991)
3 M.D. Leek and Y.M. Barlow, “Tissue reactions induced by hydrocolloid wound dressings,” J. Anat.,180, 545-551 (1992)