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Wound Management & Surgical Reconstruction (WMSR)

The Wound Management & Surgical Reconstruction (WMSR) franchise provides treatment options for chronic wound management, reconstructive procedures, and acute burns. Using LifeNet Health’s proprietary Matracell® technology, WMSR offers Dermacell®, a sterile, ready to use, human acellular dermal matrix. Dermacell is utilized for soft tissue reconstructive procedures such as breast reconstruction, the treatment of chronic wounds as well as providing a treatment option for burn management. Cryopreserved skin grafts provide a biological dressing for acute burn treatment.

Wound Management & Surgical Reconstruction (WMSR)

  1. Dermacell
    1. Advanced Wound Management (AWM)
    2. Soft Tissue Reconstruction
    3. Reimbursement
  2. TheraSkin
    1. Wound
  3. Cryopreserved Skin
    1. Acute Burn Management
  4. Dermacell AWM Clinical Review
    1. Matracell Technology
    2. Case Studies
    3. Non-Clinical White Papers
    4. Economics
    5. Surgeon Perspective
    6. Published Clinical Literature
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Description
Dermacell AWM is a technologically advanced human acellular dermal matrix that is decellularized using Matracell®, a proprietary, patented, and validated processing technology. Matracell removes a minimum of 97% of donor DNA, allowing for rapid cellular infiltration and re-vascularization. Dermacell AWM is terminally sterilized, ready to use without refrigeration or re-hydration.
 
  • Biohospitable: Cells and ≥ 97% donor DNA removed to potentially minimize any adverse patient response
  • Intact Acellular Framework: Retains native growth factors, collagen and elastin
  • Room Temperature Storage: Ready to use out of the package
  • Strength: Pull-out strength and load to failure are comparable to native dermis
  • Sterile: Sterilized to a Sterility Assurance Level (SAL) of 10-6, medical device-grade sterility
  • Structural Support: Facilitates use with sutures, staples
  • Proven: Conducted the largest randomized controlled trial (RCT) to date using hADM in chronic wounds.1

 

1. Cazzell, S., Vayser, D., Pham H., et al. A randomized clinical trial of a human acellular dermal matrix demonstrated superior healing rates for chronic diabetic foot ulcers over conventional care and an active acellular dermal matrix comparator. Wound Repair and Regeneration. 2017.

Clinical Application

Chronic Wounds* – Diabetic foot ulcers (DFUs), venous stasis ulcers (VSUs), arterial ulcers, pressure ulcers, dehisced surgical wounds, traumatic burns

* Dermacell AWM can be used over exposed tendon, bone, joint capsule, and muscle

Order CodeDescriptionSize
DCELL100

Unmeshed

2 x 2 cm (0.2 - 1 mm thickness)
DCELL101

Unmeshed

4 x 4 cm (0.2 - 1 mm thickness)
DCELL102

Unmeshed

5 x 7 cm (0.2 - 1 mm thickness)
DCELL103

Unmeshed

6 x 7 cm (0.2 - 1 mm thickness)
DCELL104

Unmeshed

4 x 8 cm (0.2 - 1 mm thickness)
DCELL110

Meshed

2 x 2 cm (0.2 - 1 mm thickness)
DCELL112

Meshed

4 x 4 cm (0.2 - 1 mm thickness)
DCELL111

Meshed

3 x 3 cm (0.2 - 1 mm thickness)
DCELL153

Meshed

6 x 7 cm (0.2 - 1 mm thickness)
DCELL152

Meshed

5 x 7 cm (0.2 - 1 mm thickness)
DCELL154

Meshed

4 x 8 cm (0.2 - 1 mm thickness)
DCELL155

Meshed

5 x 9 cm (0.2 - 1 mm thickness)
Description

Dermacell is a technologically advanced human acellular dermal matrix that is decellularized using Matracell®, a proprietary, patented and validated processing technology. Matracell removes a minimum of 97% of donor DNA, allowing for rapid cellular infiltration and re-vascularization. Dermacell is terminally sterilized, ready to use without refrigeration or re-hydration.

  • Biohospitable: Cells and ≥ 97% DNA removed to minimize any adverse patient response
  • Intact Acellular Framework: Retains native growth factors, collagen and elastin
  • Room Temperature Storage: Ready to use out of the package via patented Preservon technology
  • Strength: Pull-out strength and load to failure are comparable to existing allograft products
  • Sterile: Sterilized to a Sterility Assurance Level (SAL) of 10-6, medical device-grade sterility
Clinical Application
  • Breast Reconstruction Post-mastectomy
Room TemperatureDescriptionSize
DCELL200

Unmeshed

4 x 12 cm (0.75 - 1.5 mm thickness)
DCELL201

Unmeshed

6 x 12 cm (0.75 - 1.5 mm thickness)
DCELL202

Unmeshed

4 x 16 cm (0.75 - 1.5 mm thickness)
DCELL203

Unmeshed

5 x 16 cm (0.75 - 1.5 mm thickness)
DCELL204

Unmeshed

6 x 16 cm (0.75 - 1.5 mm thickness)
DCELL205

Unmeshed

8 x 16 cm (0.75 - 1.5 mm thickness)
DCELL206

Unmeshed

8 x 20 cm (0.75 - 1.5 mm thickness)
DCELL207

Unmeshed

16 x 20 cm (0.75 - 1.5 mm thickness)
DCELL208

Unmeshed

20 x 20 cm (0.75 - 1.5 mm thickness)
DCELL209

Unmeshed

20 x 25 cm (0.75 - 1.5 mm thickness)
DCELL250

Unmeshed

4 x 12 cm (1.25 - 2 mm thickness)
DCELL251

Unmeshed

6 x 12 cm (1.25 - 2 mm thickness)
DCELL252

Unmeshed

4 x 16 cm (1.25 - 2 mm thickness)
DCELL253

Unmeshed

5 x 16 cm (1.25 - 2 mm thickness)
DCELL254

Unmeshed

6 x 16 cm (1.25 - 2 mm thickness)
DCELL255

Unmeshed

8 x 16 cm (1.25 - 2 mm thickness)
DCELL256

Unmeshed

8 x 20 cm (1.25 - 2 mm thickness)
DCELL257

Unmeshed

16 x 20 cm (1.25 - 2 mm thickness)
DCELL258

Unmeshed

20 x 20 cm (1.25 - 2 mm thickness)
DCELL259

Unmeshed

20 x 25 cm (1.25 - 2 mm thickness)
DCELL217M

Microperforated

16 x 20 cm (0.6 - 1.05 mm thickness)
DCELL216M

Microperforated

8 x 20 cm (0.6 - 1.05 mm thickness)
DCELL216

Unmeshed

8 x 20 cm (0.6 - 1.05 mm thickness)
DCELL215M

Microperforated

8 x 16 cm (0.6 - 1.05 mm thickness)
DCELL214

Unmeshed

6 x 16 cm (0.6 - 1.05 mm thickness)
DCELL214M

Microperforated

6 x 16 cm (0.6 - 1.05 mm thickness)
DCELL215

Unmeshed

8 x 16 cm (0.6 - 1.05 mm thickness)
Description

Dermacell AWM®

Information regarding Dermacell AWM reimbursement is available in the following guides:

For additional information regarding Dermacell AWM reimbursement, please call the Pre-Authorization and Coding Hot-Line at 866-562-6349 or email dermacell@mcra.com. 

 

Dermacell® for Breast Reconstruction

 For information regarding reimbursement for Dermacell for breast reconstruction, please call is 800-698-9985 or email endoscopy.reimbursement@stryker.com.

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Description
TheraSkin is a biologically active, cryopreserved human skin allograft, composed of living cells, fibroblasts and keratinocytes, and a fully developed extracellular matrix (ECM) in its epidermal and dermal layers. TheraSkin provides, upon application, a supply of growth factors/cytokines, and a robust collagen scaffold to jumpstart healing in a chronic wound.
 
TheraSkin can be used throughout the full spectrum of healing for virtually all types of chronic wounds. TheraSkin can be applied on chronic wounds with exposed muscle, bone, tendon and joint capsule including, but not limited to, diabetic foot ulcers (DFUs), venous leg ulcers (VLUs), arterial ulcers, dehisced surgical wounds, pressure ulcers and wounds that might otherwise require an autograft.
Order CodeDescriptionSize
102TSL

Meshed

2.00 x 3.00 in (5.1 x 7.6 cm)
101TSS

Meshed

1.00 x 2.00 in (2.5 x 5.1 cm)
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Description
Cryopreserved human skin is composed of frozen fibroblasts and keratinocytes, and a fully developed extracellular matrix (ECM) in its epidermis and dermis layers. Cryopreserved human skin provides, upon application, a biological wound dressing for acute burn injuries and other soft tissue needs.
 
  • Biological barrier to minimize the threat of bacterial or fungal contamination
  • Thermoregulation
  • Capacity for regeneration and healing in the recipient
  • Adherence
  • Elasticity
  • Long shelf life
  • Minimal prep time
Clinical Application
  • Biological dressing for traumatic burn injuries
  • 2nd & 3rd degree burns
  • Cosmetic reconstruction after traumatic burn injuries
FrozenDescriptionSize
SK NM

Meshed 

1/8 sq ft or 125 cm² (1.5:1)
SK F

Meshed

1/6 sq ft or 154 cm² (1.5:1)
SK M

Meshed

1/4 sq ft or 232 cm² (1.5:1)
SK Z

Meshed

1/4 sq ft or 232 cm² (2:1)
SK HM

Meshed 

1/2 sq ft or 500 cm² (1.5:1)
SK B

Unmeshed

16 sq cm²
SK N

Unmeshed

1/8 sq ft or 125 cm²
SK S

Unmeshed

1/6 sq ft or 154 cm²
SK P

Unmeshed

1/4 sq ft or 232 cm²
SK H

Unmeshed

1/2 sq ft or 500 cm²
Description

 
 
 
 
 
 
DECELLULARIZATION
The Matracell process — utilized in cardiovascular and dermal allografts — yields a strong, acellular scaffold that facilitates cell proliferation, cell migration and vascularization. Only tissue processed with Matracell technology meets the threshold of being truly decellularized, minimizing the possibility of an immune response.
 
Although several dermal products claim to be “decellularized”, not all decellularization processes meet the definition developed by Crapo, Gilbert, and Badylak.* After evaluating remodeling responses and adverse cell and host responses, the authors determined that an ADM needs to contain less than 50ng dsDNA/mg to satisfy the intent of decellularization. Only Matracell‑treated tissue meets that criteria.
 
  • *Crapo PM, Gilbert TW & Badylak SF. An overview of tissue and whole organ decellularization processes. Biomaterials. 2011. April;32(12):3233-3243

Peer Reviewed Articles

White Papers and Technical Papers

Description

Objectives:
Diabetic foot ulcers (DFUs) with exposed bone or tendon can be difficult to heal. These recalcitrant wounds can create an economic burden because they often require multiple treatment applications. New research is needed to identify cost-effective solutions. Both D-ADM* and vCHPM^ have shown success in treating bone-exposed ulcers. This health economics analysis compared the cost of each skin substitute
using CMS cost schedules.
Methods:
DFU healing rates and the number of applications needed to achieve healing were retrospectively obtained from two similar studies.1,2 The cost of healing one DFU in a hospital outpatient department (HOPD) was calculated using [(# of Applications)*(Bundled HOPD payment + Physician Payment)].

The cost of healing one DFU in a physician’s office was calculated using [(# of Applications)*(Product Cost per Application + Physician Payment)]. Treatment costs for HOPD were extracted from Quarter 3 2018 CMS Addendum B OPPS Payment using CPT code 15275. Skin substitute cost was calculated using October 2018 Medicare Average Selling Price for vCHPM and invoice cost for D-ADM.3 The smallest graft size needed to cover a 5 cm2 wound was used for calculating cost.

 
 
Brian Samsell, LifeNet Health, Virginia Beach, VA
Shawn Cazzell, DPM, FAPWCA, FAPWH, Limb Preservation Platform, Fresno, CA
Peter Moyer, DPM, FACFAS, AAPWCA, Purvis-Moyer Foot and Ankle Center, Rocky Mount, NC

References

1. Frykberg RG, Gibbons GW, Walters JL, Wukich DK, Milstein FC. A prospective, multicentre, open-label, single-arm clinical trial for treatment of chronic complex diabetic foot wounds with exposed tendon and/or bone: positive clinical outcomes of viable cryopreserved human placental membrane. Int Wound J. 2017;14(3):569-577.
2. Cazzell S, Moyer P, Samsell B, Dorsch K, McLean J, Moore M. A Prospective, Multicenter, Single-Arm Clinical Trial for Treatment of Complex Diabetic Foot Ulcers with Deep Exposure Using Acellular Dermal Matrix. Adv Skin Wound Care. 2019. In Press.
3. Centers for Medicare & Medicaid Services. #100-04 Medicare Claims Processing Manual. Chapter 17 - Drugs and Biologicals. Section 20.1.3. 2017.
Description

Dr. Zakee O. Shabazz, DPM,  discusses his experience using Dermacell AWM when treating stalled healing diabetic foot ulcers. Dermacell AWM is a human acellular dermal matrix (ADM) that serves as a scaffold to reinforce damaged or inadequate soft tissue during wound healing. Dermacell AWM is decellularized using LifeNet Health's proprietary and validated Matracell® decellularization technology -- and is currently the only ADM that meets the definition of decellularization while preserving the extracellular matrix (ECM) that aids in the healing cascade.

Dr. Shabazz practices in the Washington D.C. area. Believing that feet provide the foundation for a healthy life, Dr. Shabazz specializes in the treatment of wound care, sports medicine, and reconstructive foot and ankle surgery.