Dermacell AWM

Advanced Human Acellular
Dermal Matrix

Dermacell AWM

ABOUT

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 is utilized for the treatment of chronic wounds as well as burn management and for soft tissue reconstructive procedures such as breast reconstruction.

TWO PHYSICALLY DISTINCT SIDES

Reticular (Dermal)

Reticular (Dermal)

Lighter in Appearance, Larger Pores, Absorbs Blood

Papillary

Papillary (Basement Membrane)

Duller with Smaller Pores, Repels Blood

doctor vector

Clinical Tip

When applied, the reticular side is placed against the surgical wound or the most vascularized tissue.

TWO PHYSICALLY DISTINCT CONFIGURATIONS

Unmeshed
Meshed
Meshed 1:5:1 Ratio

Product Features

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2-Intact Acellular Framework

Intact Acellular Framework:

Retains native growth factors, collagen and elastin

3-Room Temperature

Room Temperature

Ready to use out of the package (15°C - 30°C)

1-Bio-hospitable

Bio-hospitable:

All cells ≥ 97% donor DNA removed to potentially minimize any adverse patient response

Strength:

Pull-out strength and load to failure are comparable to native dermis

5-Sterility

Sterility:

Sterilized to a Sterility Assurance Level (SAL) of 10-6, medical device grade sterility

6-Structural Support

Structural Support:

Facilitates use with sutures, staples

7-Proven Efficacy

Proven Efficacy:

Conducted the largest randomized controlled trial (RCT) to date using hADM in chronic wounds

8-Tensile Strength

Tensile Strength:

Demonstrated ultimate tensile strength of 635.4 + 199.9N

Suture Strength:

As per biochemical testing the suture retention strength is 134.6 + 55.1N

MATRACELL DECELLULARIZATION TECHNOLOGY

Matracell gently renders allografts acellular without compromising the biomechanical
or biochemical properties, growth factors, collagen, and elastinthat supports patient healing.

1- Step icon - Decellularization
Mask Group 14

STEP - 01

Decellularization

2 - Step icon - Rinsing
Mask Group 13

STEP - 02

Rinsing

STEP - 03

Preservation

4 - Step icon - Sterilization
Mask Group 15

STEP - 04

Sterilization

USAGE INFORMATION

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durch Humor oder zufällige Wörter welche.
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Would Bed Preparation

Proper wound bed preparation is vital to successful wound healing, If the wound bed is not properly prepared, DermACELL AWM may not integrate as intended.

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DermACELL AWM Application

Ensure hemostasis has occurred prior to the application of DermACELL AWM. If mild bleeding is present, apply pressure for 10 minutes before applying DermACELL AWM. If unable to achieve hemostasis, apply compression dressings and have the patient return the following week for application of DermACELL AWM.

Apply DermACELL AWM with the reticular side against the wound bed using aseptic/sterile technique.

Ensure intimate contact is maintained between the wound bed and DermACELL AWM by gently pushing it towards the middle of the wound. (The edges of DermACELL AWM can be trimmed to meet the perimeter of the wound bed or overlap the wound margin by a few millimeters.

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DermACELL AWM Fixation

DermACELL AWM should be secured to the wound bed with sutures, staples or SteriStrips to ensure DermACELL AWM remains in contact with the wound bed.

DermACELL AWM
Top Dressing Application

Cover DermACELL with a non-adherent primary dressing, bolster and/or padding, particularly if the wound has moderate to heavy exudate.

The primary dressing should be secured with an outer wrap a.k.a. secondary dressing because it not only secures the primary dressing, but acts as a protectant for the graft too.

FIELDS OF APPLICATION

DermACELL AWM has demonstrated applicability in a variety of medical procedures, including chronic wounds, traumatic wounds, injuries and surgical reconstruction.
DermACELL AWM is able to be applied to any non-healing wound, including application over exposed tendon or bone.

FAQ’s

An allograft is tissue taken from one person for transplantation into another after it has been processed.
Chronic Wounds-Diabetic foot ulcers, Pressure ulcers and Venous ulcers Surgical Reconstruction-Surgical wounds, Soft tissue, Reconstruction, Donor sites Traumatic Wounds-First and second degree, burn, Lacerations, Cuts and Abrasions.
Prior to donation, the donor’s medical and social history are screened for medical conditions or diseases that would contraindicate the donation of tissues in accordance with current policies and procedures approved by Life Net Cell. Donor blood samples taken at the time of collection are tested negative/non -reactive for relevant communicable and infectious disease agents at Life Net Cell International, which has requisite national and/or international accreditations.
  1. HIV-1/2 antibody & HIV antigen
  2. Hepatitis B surface antigen
  3. Hepatitis B core antibody
  4. Hepatitis C antibody
  5. Syphilis
  6. Malaria
  7. HTLV I & II antibody
  8. CMV IgG

No, each product is for single use only.

Each product is for single patient use only.

The products can be stored in a clean, dry environment at ambient room temperature (15-30C). There is no need for refrigeration or freezing.

No, our products do not contain any live cells.

  • Proprietary processing using patented Matracell technology (97% donor DNA is removed) and validated sterilization methods, patented PRESERVON technology (SAL 10-6) are used to eliminate potential deleterious components of the allograft.
  • The chances of graft rejection or infection is one in the million.
  • However, the product should be used with caution in patients with a known intolerance towards Ofloxacin, Vancomycin, and Amphotericin B antibiotics
  • Greater than or equal to 97% of DNA removed
  • Intact acellular framework
  • Structural support for cells
  • 10-6 sterility assurance level
  • Room temperature storage
  • Ready-to-use
  • The distributor, intermediary and/or end-user clinician or facility is responsible for storing decellularized dermis under appropriate conditions prior to further distribution or implantation. Dermis must be stored at room temperature (15°C to 30°C).
  • Do not freeze or refrigerate.
  • Minimize excessive exposure to light and protect from excessive heat.
Meshed: 2cmx2cm, 3cmx3cm, 4cmx4cm, 4cmx8cm, 5cmx7cm, 5cmx9cm, 6cmx7cm. Unmeshed: 2cmx2cm, 4cmx4cm, 4cmx8cm, 5cmx7cm, 6cmx7cm.

Complications can occur because of various factors:

  • Infection – Remove DermACELL, control the infection and apply a new matrix following adequate wound bed preparation
  • Detached or displaced matrix – Remove DermACELL and assess to establish the reasons for failure. Perform adequate wound bed preparation before applying a new matrix.
  • Excessive inflammation/allergic reaction – Remove DermACELL and do not reapply a new matrix.
  • Failure to heal/lack of effect – Reassess the wound and the patient. When the wound is not healing the matrix may be displaced and there may be an increase in wound size.

Acellular dermal matrix meshing reduces rates of postoperative seroma, hematoma, and infection and decreases drain removal time compared with non-meshed acellular dermal matrix.

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