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| Wound Care \ DermaSeal |
Features & Benefits
| Features and Benefits of DermaSeal Skin Closure Strips
Features and benefits always play an important role in selling medical products, particularly when there are superior or unique issues that should be passed on to the customer.
FEATURE | BENEFIT | Superior Adherence | Adheres in adverse conditions, i.e. water activities, such as bathing and swimming. No Tincture of Benzoin needed for adherence.
| Breathability | Maintains high level of breathability due to porous adhesive and backing allowing for faster healing. | Rounded Ends | Aid in the sound attachment of DermaSeal because it won’t lift off when rubbed against clothing or bedding. | Unequaled conformability | Soft and gentle, yet, aggressive adhesive and non-woven backing provide a conformable strip that contours to the body’s natural curves. | Slight stretch and memory | Ability to slightly stretch and remember the initial position allows for applications under slight tension, to accurately pull the skin flaps together, creating a quality skin closure. | Tensile strength | Cross directional, Machine direction strength. Product expands moderately in both directions to move with body’s natural motion. | Water resistance and durability | Stays fixed in place, whether swimming or bathing. Won’t lift off when rubbed against clothing or bedding. | Time saver | Provides skin closure in less time than suturing, clipping, or stapling, without the need for local anesthetic on application or removal of strips. | Economical | Less cost associated with using strips compared to sutures and staples (8 to 1 for sutures and 25 to 1 for staples) | Minimal scarring | Minimized scarring by bringing the skin flaps together under slight tension creating a sound closure without crosshatch or puncture scars. | Less Trauma | Greater patient comfort | Aids in healing | Reduces possibility of suture, clip, or staple infection. Reduces possibility of post-surgical edema and resulting necrosis and inflammation. A repositionable method to permit wound drainage, if necessary, no damage to the skin on removal. | Patient preference | Eliminates patient discomfort associated with suturing and stapling by increasing patient mobility, providing painless application and removal. |
Physical Property Comparison Testing
Of
Personna Medical’s DermaSeal and Competitive Brands
The physical structure of the tape will determine its performance. Surgical tapes are composed of a fibrous backing and chemical adhesive. The backing supports the adhesive and distributes the forces encountered in the contact area of application. The adhesive layer provides the coupling between the skin and the backing. Three surgical tapes were evaluated in this study: a non-woven polyamide tape (DermaSeal, Personna Medical, Staunton, VA), a non-woven reinforced tape (Steri-Strips, 3M Co., St. Paul, MN) and a spunbonded non-woven tape (Proxi-Strips, Ethicon, Somerville, NJ).
Adherence Testing
The selection of surgical tape for sutureless wound closure depends, in part, on the ability of the tape to adhere to the skin. Its adhesion to the underlying skin is one of the most important factors since this will ensure secure wound edge approximation.
Adhesion of the surgical tapes to skin was quantified by measuring their shear adhesion to the skin of human volunteers. The test sites were washed, rinsed copiously with water and then thoroughly dried with gauze. The tape strips were applied to the inside forearm of the human volunteers. Tape samples (1/2" wide) were applied sequentially within the confines of the test area. Care was taken to apply as little pressure as possible to the tapes. The adhesion skin test was an adhesive sheer strength measurement of the strips’ bond to skin (at 0-degree angle – straight pull).
Two further tests were performed on stainless steel and glass, respectively.
ADHERENCE TEST DATAProduct | Adherence to Stainless Steel | Adherence to Skin | Adherence to Glass | DermaSeal | 268 gms | 804 gms | 223 gms | 3M Steri-Strip ä | 170 gms | 426 gms | 179 gms | Ethicon (J&J) Proxi-Strip ä | >1100gms* | 602 gms | >1100 gms* | Genetic Labs Suture Strip Plus | Matl change | Matl change | Matl change |
*During the adhesion tests to stainless steel and glass, the Proxi-Strip backing delaminated and separated from the adhesive leaving the adhesive on the test surfaces.
Discussion
Test results indicate DermaSeal has the best performance where it counts - - adhesion to human skin. Under these test conditions, DermaSeal provides 89% higher adhesion to skin than the leading brand. Adhesions to stainless steel and glass tests were performed to gain some base reference for adhesive performance. To our knowledge, no one has successfully correlated values for adhesion to stainless steel and glass with values on human skin.
Breathability (Air Porosity) Testing
The backings of these tapes have synthetic fibers distributed randomly throughout a web. These random laid fibers create numerous microporous passages, which allow air to travel through the backing from one surface to the other.
It is generally accepted that it is desirable to retain a large percentage of the backings original air porosity after adhesive coating. So, one measure of a surgical tape's efficiency is the porosity of the combination of backing and adhesive.
Tape samples were 1/2" wide and were used directly from individual sterile packets.
The porosity of a tape can be quantified by measuring the volume of air that passes through a defined area of one square meter over a time period of one second.
BREATHABILITY TEST DATA
Product | Breathability | DermaSeal | 21 dm3/m2/sec. | 3M Steri-Strip ä | 11 dm3/m2/sec. | Ethicon (J&J) Proxi-Strip ä | 12 dm3/m2/sec. | Genetic Labs Suture Strip Plus | Matl change |
Note: dm3/m2/sec.= decimeter cubed/meter squared/second.
Discussion
DermaSeal offers 90% more breathability than the leading brand. This ration is important due to a general belief by healthcare professionals that wounds, particularly incisions, heal faster when exposed to air.
Irritation of the skin by tape can be correlated, in part, with tape occlusivity. Tapes that limit air transmission lead to an accumulation of fluid underneath the tape, promoting tissue maceration and bacterial growth.
Porous tapes allow moisture to be transmitted through the pores of the tape, resulting in a dry skin beneath the tape, which is not conducive to bacterial growth.
Tensile (Breaking Strength and Elongation Testing)
Tapes used for wound closure must be strong enough to withstand the forces acting to disrupt the wound edges. Tensile strength and elongation testing are used to measure this ability.
The tensile strength of the tapes was determined by measuring the force in grams required to break the strips.
The ability of a skin closure tape to stretch elongate under increasing loads is beneficial because it reduces the shearing forces on the wound edges that prevents the development of blisters at the tape ends.
The maximum elongation of the tapes was determined by measuring the amount of total elongation of each tape in grams at the time breakage occurred.
Tape samples were ½" wide and were used directly from individual sterile packets.
TENSILE STRENGTH and ELONGATION TEST DATA
Product |
Max. Elongation | Tensile Strength | DermaSeal | 19% | 3,629 grams | 3M Steri-Strips ä | 12% | 4,196 grams | Ethicon (J&J) Proxi-Strip ä | 25% | 2,268 grams | Genetic Labs Suture Strip Plus ä | Matl change | Matl change |
Discussion
Max. Elongation
The balance characteristics to best maintain wound edges during activities that can disrupt wound edges are those in the middle range on the scale. Ideally, the tape should elongate when subjected to low forces to accommodate any swelling of the underlying tissue. When subjected to stronger forces, it should resist further elongation in order to maintain approximation of the wound edges. DermaSeal performs in the mid range. While DermaSeal is 58% more flexible than 3M Steri-Strips, it is 32% less flexible than Ethicon Proxi-Strips (these are too flexible)
Tensile Strength
Tapes must be strong enough to withstand the forces acting to disrupt the sound edges. The breaking strength of a surgical tape must be sufficient to maintain wound approximation during healing.
DermaSeal has a tensile strength 16% less than 3M Steri-Strips, and is 60% higher than Ethicon Proxi-Strips. Although reinforced Steri-Strips have a 16% higher breaking strength than DermaSeal; this parameter offers no clinical advantage, because tape breakage is not encountered with any skin closure strips.
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