BIOSTEP

Collagen Matrix Dressing Range

About BIOSTEP

Description

BIOSTEP is a unique collagen matrix dressing that allows you to overcome barriers to wound closure while maintaining an optimal moist wound environment. It targets and deactivates excess MMPs and has a 6-day wear time for prolonged control of the wound environment. The highly conformable dressing is easy to apply, and its gelling actions provide a cooling, soothing effect for enhanced patient comfort. BIOSTEP Ag combines the anti-MMP activity and functionality of BIOSTEP with the antibacterial activity of silver to help maintain bacterial balance for contaminated and colonized wounds.

Features & Benefits

  • Unique Dual-Action MMP Targeting & Deactivation
    MMP Targeting: contains both type 1 and denatured (gelatin) porcine-derived collagen. This novel collagen matrix attracts and serves as sacrificial substrates for a broad array of MMPs which are found in excess within, and contribute to the chronicity of, chronic wounds. MMP Deactivation: contains EDTA (a proven MMP modulating agent) which permanently deactivates excess MMPs, providing prolonged, targeted MMP control without altering the activity of essential growth factors. This contributes to a longer wear time.  
  • Patient Friendly
    CMC within dressing gels on contact with moisture providing improved patient comfort by creating a soothing, cooling effect upon application. Up to a 6-day wear time provides for fewer dressing changes and prolonged control of wound environment.  
  • Easy to Use
    CMC within dressing adds structure for easy application when moist. Highly conformable to ensure close contact with wound bed.  
  • Moisture Manager
    Alginate absorbs a high level of exudate away from the wound bed to the secondary dressing maintaining an optimal moisture balance for wound closure.


Indications

Management of full-thickness and partial-thickness acute and chronic wounds including:

  • Pressure ulcers
  • Diabetic ulcers
  • Ulcers caused by mixed vascular etiologies
  • Venous ulcers
  • First and second degree burns
  • Donor/graft sites
  • Abrasions
  • Dehisced surgical wounds
  • Traumatic wounds healing by secondary intention


Contraindications

  • Do not use on patients with a known allergy or sensitivty to porcine collagen or any other ingerdient.
  • Do not use on third degree burns.


Precautions

  • If sensitivity to BIOSTEP develops, discontinue use.
  • BIOSTEP dressings may be used under compression therapy under the supervision of a health care professional.
  • United States' federal law restricts this device to sale by or on the order of a physician.
  • The contents of the dressing should be used on one patient only.
  • The product is for external use only.
  • Contact with the skin around the wound's edges and intact skin should be minimized.


Ordering Codes

Product # Description Size Pcs/Pkg HCPCS
66800124 BIOSTEP Collagen Dressing 2” x 2” 10 A6021
66800125 BIOSTEP Collagen Dressing 4” x 4” 10 A6021
66800126 BIOSTEP Ag Collagen Dressing w/ silver 2” x 2” 10 A6021
66800122 BIOSTEP Ag Collagen Dressing w/ silver 4”x 4” 10 A6021



Mode of Action

Mode of Action

Chronic wounds are characterized by an over abundance of matrix metalloproteinases (MMPs). At high levels, MMPs not only degrade non-viable collagen, but also degrade viable collagen, preventing the formation of granulation tissue and wound closure.1 When either BIOSTEP or BIOSTEP Ag is placed in a wound, MMPs attack and break down the collagen-based dressing since it serves as a ‘sacrificial substrate' for the MMPs.2 The resulting degradation products call in other cells, such as fibroblasts and endothelial cells, necessary for the formation of granulation tissue3-10 Unique to BIOSTEP and BIOSTEP Ag is the addition of ethylenediaminetetracetic acid (EDTA), which permanently deactivates a portion of the MMPs, preventing them from degrading viable collagen in the wound bed. MMPs contain zinc ions, necessary for their activity. EDTA binds with zinc ions to deactivate MMPs. Other collagen dressings available on the market attempt to reduce MMP activity through modes of acton separate from those of BIOSTEP and BIOSTEP Ag. For example, some contain oxidized regenerated cellulose (ORC) which creates a pH of ~ 2.5, well below physiological pH, to hydrolyze and deactivate MMPs. However, this low pH can damage growth factors as well as various cell types. While some other collagen dressings contain only collagen as a ‘sacrificial substrate'. In this type of system, once the MMPs have broken down the dressing, the MMPs are released back into the wound, fully functional and able to degrade viable collagen again. Also unique to BIOSTEP and BIOSTEP Ag is the types of collagen used. Both are the only collagen dressings on the market to date which contain both type I collagen and denatured collagen. This recipe attracts a greater variety of MMPs than do other dressings, thus protecting the “good” collagen in the wound from a wider variety of MMPs. For example, type I (native) collagen attracts MMP-1, and denatured collagen (gelatin) attracts MMP-2 and MMP-9.11,12 Denatured collagen also attracts stromelysins and matrilysin.13 MMP-1, MMP-2, and MMP-9 (among others) are each found in excess in chronic wounds and contribute to a wound's chronicity. When a migrating cell (i.e., keratinocyte) comes in contact with type 1 collagen the cell secrets MMPs in order to denature the type 1 collagen to gelatin.14 A critical reason for this is that once type 1 collagen is converted into gelatin many actives sites (i.e. RGD sequences) are made accessible to the cells. RGD (Arg-Gly-Asp) sequences are attachment sites and chemotactic for a variety of cells responsible for creating granulation tissue. The gelatin component of BIOSTEP and BIOSTEP Ag provides enhanced signaling to the cells responsible for creating granulation tissue. Other collagen dressings do not contain gelatin; as a result, cells in the wound must first release MMP-1 into a wound that already has an overabundance of MMPs to change the type 1 collagen into gelatin to achieve this benefit. Finally, unique to BIOSTEP and BIOSTEP Ag is a longer wear time than that of other collagen dressings. BIOSTEP and BIOSTEP Ag are FDA approved for 6 days of use; whereas, other collagen dressings are only approved for 3 days of wear. Due to the carboxymethylcellulose (CMC) and alginate components of BIOSTEP and BIOSTEP AG, they are more absorbent than other collagen dressings.15

References:

  1. Schultz G, Mast B. Molecular Analysis of the Environment of Healing and Chronic Wounds: Cytokines, Proteases and Growth Factors. Wounds 1998;10:1F-9F.
  2. Bailey A. Perspective article: the fate of collagen implants in tissue defects. Wound Repair Regen 2000;8:5-12.
  3. Montesano R, Orci L, Vasselli F. In vitro rapid organization of endothelial cells into capillary-like networks is promoted by collagen matrices. J Cell Biol 1983;97:1648-52.
  4. Madri JA, Marx M. matrix composition, organization and soluble factors: Modulation of microvascualr cell differentiation in vitro Kidney Int 1992;41:560-5.
  5. Albini A, Dadelmann-Grill BC. Collagenolytic cleavage products of collagen type I as chemoatractants for human dermal fibroblasts, Eur. J Cell Biol 1985;36:104-7.
  6. Doillon CJ, Silver FH. Collagen-Based Wound Dressing: Effects of Hyaluronic Acid and Fibronectin on Wound Healing. Biomaterials 1986; 7:3-7.
  7. Doillon CJ, Silver FH, Olson RM, Kamath CY, Berg RA. Fibroblast and Epidermal Cell-Type I Collagen Interactions: Cell Culture and Human Studies. Scanning Microscopy 1988; 2(2):985-992.
  8. Burton JL, Etherington DJ, Peachey RDG. Collagen Sponge for Leg Ulcers. British Journal of Dermatology 1978; 5:726.
  9. Doillon CJ, Whyne CF, Berg RA, Olson RM, Silver FH. Fibroblast-Collagen Sponge Interactions and Spatial Deposition of Newly Synthesized Collagen Fibers in Vitro and in Vivo. Scanning Electron Microscopy 1984; 3:1313-1320.
  10. Palmieri B. Heterologous Collagen in Wound Healing: A Clinical Study. International Journal of Tissue Reaction 1992; 14:21-25.
  11. Jeffrey J. Metalloproteinases and Tissue Turnover. WOUNDS, A Compendium of Clinical Research and Practice. Vol 7, Supplement A, September/October 1995, p13A-22A.
  12. Parks WC. The Production, Role, and Regulation of Matrix Metalloproteinsases in the Healing Epidermis. WOUNDS, A Compendium of Clinical Research and Practice. Vol 7, Supplement A, September/October 1995, p23A-A33).
  13. Clark RAF, ed: In The Molecular and Cellular Biology of Wound Repair, 2nd Edition. NY, Plenum Press, 1996, pp. 443.
  14. Pilcher, BK, Dumin JA, Sudbeck BD, Krane SM, Welgus HG, Parks WC. The Activity of Collagenase-1 Is Required for Keratinocyte Migration on a Type I Collagen Matrix. The Journal of Cell Biology, Volume 137, Number 6, June 16, 1997 1445-1457.
  15. Data on file: Determination of Degradation Profile of Collagen Dressings (WRP_TW042_641).

Clinical Evidence

Clinical Evidence

Wound Type Author(s) Title of study Case study/ Poster/ CIME
Arrested/stalled wound R. Williams, MD, CWS Novel porcine collagen matrix used to stimulate wound closure in arrested wounds PDF
Granulating wounds post use of Negative Pressure Wound Therapy (NPWT) R. Williams, MD, CWS Clinical experience with a novel porcine collagen matrix to facilitate final closure of granulating wounds originally treated with NPWT PDF
Non healing wounds K. Hermann, MSN, ACNP-BC, D. D. Peterson, CCRN, MSN, ACNP-BC J. Niezgoda, MD, FACHM, FAPWCA, FACEP Collagen carboxylmethyl cellulose for the management of chronic non-healing wounds PDF
Variety
DFU
Radiation burn
R. Allam, MD, MBA R. Partain, RN B. Munson, RN, BSN, WOCN A prospective, clinical in market evaluation to assess the performance of a new collagen matrix dressing on facilitating granulation and epidermal migration in a variety of wound types PDF
Variety C Davis, MD, CWS C Dalbey, RN, BSN S Hill, RN, BSN, CWOCN The successful use of a new adjunct therapy in a both acute and chronic wounds - a prospective, descriptive case series PDF
Stalled wound post use of IODOSORB and NPWT R. Williams, MD, CWS Experience with novel porcine collagen matrix and silver used in long-term dressings PDF

Resources

Downloadable Materials

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Instructions for Use

Step 1

Prior to application, the wound bed should be debrided and then irrigated with an appropriate wound cleanser or water.

Step 2

The dressing should be cut to fit the wound size exactly. For heavily exudating wounds, the dressing should be applied directly to the wound bed. For dry wounds with minimal exudate, the wound bed should be moistened with water to begin the gelling process.

Step 3

BIOSTEP should be covered with a suitable secondary dressing.

Step 4

Dressings may be changed daily or as good nursing practice dictates.

Dressing Removal

  • Remove secondary dressing with care. Gently remove BIOSTEP Collagen Matrix Dressing ensuring that the dressing removal does not damage delicate newly-formed tissues.
  • Dressings may be left in place for up to six days depending on the level of exudate or as good nursing practice dictates.