THE SKIN & BLOOD FLOW WITH DIABETES

THE SKIN & BLOOD FLOW WITH DIABETES

Our skin provides many vital functions, among them protection from infection, warnings via sensation and temperature regulation.  Blood flow provides the skin with nutrients and oxygen.  A disease like diabetes that affects blood flow will cause 1/3 of diabetics to develop skin problems over their lifetime if blood sugar is not under control and preventive care is not taken.

Blood flow is affected on several levels; the vessels and the blood itself.  Elevated blood sugar levels cause narrowing of all sized vessels by buildups of sugar based complexes within the walls of the vessels, thus causing narrowing.  Furthermore, there is inflammation within the blood vessels and actual changes within the structure of red blood cells themselves.  The result is a reduced supply of blood to all structures within the skin.  Controlled blood sugar levels reduce the damages and also keep the moisture content of the skin normal.

It is vital to maintain and protect the skin from developing problems because diabetics are also more susceptible than the unaffected population to problems should they develop.  The skin becomes thin, dry, heals slower, looses its protective barrier from bacteria and in the feet may loose its protective sensation.  These problems may progress to bacterial and fungal infections, inability to feel blisters or ulcers and serious loss of toes, the feet and even lower legs. Infections alter blood sugar levels, thus setting up a vicious cycle.  The skin should be checked frequently, moisturized, cleansed, protected, and feet properly dried.  Preventive care is key so avoid adhesive tapes (see Tapeless and Diabetes), abrasives, poorly fitted shoes, tight apparel and a maintain the proper diet.

Sterility and Tapeless

STERILITY AND TAPELESS

Occasionally the question of sterility and the use of Tapeless dressing holders is asked.  Obviously the nature of the wound and any special circumstances under which the product is to be used is important, but even with this question, Tapeless demonstrates its versatility with no compromise in clinical efficacy.  Most wounds by definition are “infected” by their very nature and concerns about secondary wound dressings are in practicality, secondary.

First, Tapeless dressing holders are categorized as secondary wound dressings.  By FDA standards this means that the dressing is not to be directly in contact with non-intact skin (the wound).  The only real FDA requirement is that the product is manufactured under certain specifications for a class I product of this type, i.e., in a “clean environment”.  This sets certain air filtration and personnel requirements.

Tapeless becomes versatile in that it may be sterilized if the use merits.  Since Tapeless is a laminate incorporating a polypropylene plastic, anything with excessive heat should be avoided.  The product may be sterilized with ethylene oxide or radiation.  This is rarely indicated.  It is not however unusual for the user to want to “clean” the product, either for cosmetic purposes or to reduce the level of contamination.  If there are any concerns, discard the product since the product by this time has most likely already been cost effective by means of its re usability.  Tapeless has studies that prove that it may be washed and reused, surprisingly even unaffected by boiling water or a substance as harsh as pure bleach.  Studies have proven that there is 100% memory in the material with repeated washings as long as the product is air dried.


There are methods to minimize possible contamination, such as more frequent dressing changes, or using a thicker layer of the primary dressing until drainage decreases.  The issue of sterility and the use of Tapeless should be determined  case by case and should not be “painted with a broad brush”.

www.tapelessmedical.com

PLASTIC SURGERY AND TAPELESS

PLASTIC SURGERY AND TAPELESS 

Perhaps no surgical subspecialty has the potential to use as many Tapeless products as plastic surgery.  The reason is simply that plastic surgeons do various procedures ranging from hand surgery to complicated reconstruction.  Often the plastic surgeon is called upon as the final solution to deal with chronic or complicated wounds.  Wound healing is their forte, and consequently the smallest of details may make a significant difference in a result.  For this reason, great attention is paid to even secondary wound dressings since they often affect the ability to heal a wound and reduce the unwanted complications of scarring and tissue loss.

The success of Tapeless is related to the design of the product and the material used.  The design imparts its influence through the ability to support the tissues, keeping the primary dressing exactly where it is placed and intended for use, and, as in the case of the breast dressing holder, can actually be used to help contour the surgically operated breast and define anatomic features such as the infra mammary fold and symmetry with the opposite breast.

The material is equally as important since compression, while helping to reduce swelling, will also reduce blood supply.  The key to a successfully healing wound is to maintain a good blood supply.  Tapeless is slightly compressive allowing for changes in swelling, up or down, that is accommodated for by the material without a need to reapply or adjust the degree of compression.  Because the material is “forgiving” in this manner, at the same time, the blood supply will not be compromised or significantly reduced.

These Tapeless qualities in of themselves make Tapeless the ideal secondary dressing for most plastic surgical procedures, and when added to the qualities not discussed, like cost effectiveness, increased patient compliance, no adhesives, latex free and no bulk, further enhance the clinical efficacy of Tapeless.

www.tapelessmedical.com

CE MARKING AND TAPELESS

CE MARKING AND TAPELESS

Obtaining a “CE” mark means more than having the ability to sell or market one’s products within the European community.  These communities, 27 member states of the EU, Iceland, Norway, Lichtenstein, Turkey, Croatia, Macedonia, Albania, Serbia and Montenegro, require a conformity of one’s products whose purpose is to protect the safety, public health and consumer from non-conforming products.

This CE marking process is extensive and thorough.  Each manufacturer is required to compile a technical file that demonstrates approved safety and regulatory standards along with detailed manufacturing, packaging and quality control procedures.  The CE mark must be displayed on the package when used in that market, providing an assurance to the consumer that the product has met the combined conformity and standards of the member nations.

To highlight the depth to which a product must conform, an outline of the manufacturer’s responsibilities include:

1.      ensure compliance product design and manufacture

2.      caring out conformity assessments

3.      draw up the technical documents

4.      draw up the EU declaration of conformity (D of C).

5.      affix the conformity marking ( CE marking)

6.      keep the technical file and D of C

7.      ensure continued conformity by reviewing on a several year cycle

8.      take into account changes in the standards or technological specifications which are stated for their product’s compliance requirements

9.      secure the type/serial/batch numbers to the product

10.  take corrective actions or withdraw/recall the products from the market when there is a reason to assume non-conformity

11.  in such cases, inform the appropriate authorities

12.  indicate name and contact address of manufacturer on the product

13.  on request, provide information/documentation to authorities and cooperate with them

Each product must have achieved the same degree of conformity so not only has Tapeless achieved a high level of efficacy and usefulness clinically, it has achieved a high level of excellence not apparent by simply looking at the product.

www.tapelessmedical.com

THE LARGE PATIENT AND TAPELESS

The reality that individuals are becoming larger and heavier is a real phenomenon.  Whether the individual undergoes a surgical procedure or has a different chronic wound, dressing the wound becomes more of a problem as the size of the patient increases.

These larger patients require more wound dressing materials to cover and secure their dressings, have greater difficulty in keeping the dressings in place as they tend to slip, rub and bind and are more likely to have complications in trying to apply their dressings.  The ineffectiveness of the traditional dressing holders like rolls of gauze, elastic netting and other wraps are magnified in this patient population.

The advantages of Tapeless are maximized in this group.  No longer is a single roll of gauze enough.  No longer do these materials remain where placed without tape or another supplemental aid.  The combination of a supplemental dressing aid and extra rolls of wrap quickly increase the cost of care without even adding in the costs of increased numbers of dressing changes.  When a problem occurs from the traditional dressing, the expense to treat these complications is also magnified.  These problems range from skin reactions to adhesives, blisters from excessive pressure or constriction and slippage of the wound dressing from the intended site to the need of additional help to apply the primary/secondary dressings.

Tapeless, with its ability to be manufactured in any size while maintaining its anatomic shape, offers immediate obvious advantages.  The larger dressing holders are still reusable, still resist slippage, are non-constrictive, easy to apply and because they are breathable and non-bulky, create a better environment for wound care for both the patient and the healthcare provider.  Cost is reduced, care is optimized and the patient is more compliant.

Tapeless currently has bariatric sizes for several products, but as the field of bariatric medicine becomes more prevalent, Tapeless encourages these specialty centers to work with us to develop size ranges and product models for the more commonly occurring needs.  In this manner, costs can be controlled, needs can be effectively addressed and patient comforts still achievable.

www.tapelessmedical.com

CHILDREN AND TAPELESS

CHILDREN AND TAPELESS

Tapeless offers children in general, and pediatrics specifically, something that none of the traditional secondary dressings can, i.e., anatomic sized wound dressing holders.  No longer are secondary wound dressings non-specific rolls of material that may or may not accommodate the needs of the patient,  The market potential for such a product is enormous and with an already clinically proven product like Tapeless, an opportunity awaits sales forces entrenched in the pediatric market.

The need of the healthcare provider is different from the desire of the child patient.  The healthcare providers want something that is cost effective, clinically proven, safe (non-constrictive) and has advantages over traditional secondary dressings.  Tapeless provides these qualities.  Children want something that is pain-free, soft to the touch and does not have any adhesives or a need to be pulled over a body part.  Tapeless has these characteristics.

Tapeless has developed specific anatomic wound dressing holders for epidermolysis bullosa children that are available to 2 different sizes that cover large age and size differences among the involved children. It is the goal of Tapeless to find a pediatric institution that has healthcare providers who wish to  help in identifying the most commonly needed dressing holders and the most commonly needed sizes.  Special ordered sizes are always available with Tapeless, but the need for a large number of variations of a particular product should not be needed due to the ability of the material to accommodate most changes in size.

With the absence of adhesives, ease of application,  soft feel and even the blue color of the material, compliance by the child will be higher.    It is then not only possible to change the primary dressing as often as is best for the care of the wound, but maybe even to enlist the older child to change his/her own wound dressing.  Changing the dressing may no longer be a test of wills between the healthcare provider and the child.

www.tapelessmedical.com

THE ELDERLY AND TAPELESS 


Tapeless has more value to the elderly than any other single age group because of the accumulation of issues that the elderly deal with.   Although Tapeless is effective with all age groups, the elderly present more clinical challenges than do other age groups.

1.         THIN SKIN      This irrefutable event affects everyone as they age.   Special care must be considered when applying any material to skin to reduce concerns of allergies, abrasiveness, adhesives and response to moisture and heat.  Tapeless material has been used for decades for diapers and female sanitary napkins.  It contains no latex, no adhesives, is hypoallergenic and breathes.

2.         COST EFFECTIVENESS         The ability to wash and re-use the Tapless products makes them very cost effective to everyone, especially the elderly.

3.         BLOOD SUPPLY         With the aging process, arterial insufficiency and venous varicosities develop which translate into ulcers and decreased wound healing.  It is important to make sure that any wound dressing holder is not compressive or further compromises an already diminished blood supply.

4.         OTHER MEDICAL PROBLEMS          With the aging process, other medical problems become manifest and may affect healing.  Diabetes is one common example.  With treatment various medications such as steroids or chemotherapy agents may necessitate the avoidance of adhesives, constrictive materials or rough textures.  TapelessÔ may be used safely.

5.         DECREASED SENSATION     Some diseases and aging may diminish the patient’s ability to sense if a dressing is too tight, leading to significant complications.  The use of Tapeless can easily accommodate any increase in swelling and does not constrict as does COBAN.

6.         EASE OF USE              Certain medical problems develop with age, like arthritis and stiff joints, that impair the ability to reach certain body parts or perform the wrapping motion that is required by several competitors.  Tapeless is applied like a clam-shell and is not slipped over any painful or stiff joint.   Tapeless attaches simply with velcro, not needing to be wrapped or applied by a second person.

Tapeless simply works because it works simply.

www.tapelessmedical.com