DermACELL PRS

Advanced Decellularized Dermis

Dermacell is a decellularized regenerative human tissue matrix allograft processed using proprietary Matracell® technology from LifeNet Health®.

Adequate blood supply is critical for successful use of decellularized regenerative human tissue matrix allografts.

LifeNet Health® has the longest running American Association of Tissue Banks  certification and is also the world’s largest full service provider of organs, tissues,  and cells. LifeNet Health has more than 30 years of experience in tissue regeneration including expertise in advanced sterilization techniques for biologic matrices

Sterile

Sterility assurance level (SAL) 10-6

Ready To Use (RTU)

No rinsing required.

Decellularized using Matracell

A proprietary and patented technology that removes at least 97% of donor DNA without compromising the desired biomechanical structure or biochemical properties for its intended use.

Rectangle Microperforated ADMs Now Available

Microperforated ADMs are increasingly being utilized in breast reconstruction as they allow fluid to flow through the matrix upon implantation, which may minimize drain placement and expedite drain removal, thereby reducing risk of infection.1, 2, 3, 4, 5

Developed for clinicians who are looking for an innovative solution for breast reconstruction, Dermacell Microperforated requires no manual meshing for enhanced efficiency in the operating room. Its proprietary and consistent mesh design was developed based on feedback from leading plastic surgeons.

Available in three rectangular sizes (6x16cm, 8x16cm, & 8x20cm)

Strength & Durability

Microperforations provide a biomechanical strength comparable to non-microperforated Dermacell and is >17 times 9 stronger than the maximum forces experienced by normal breast tissue. 6

Operative Benefits

Dermacell Microperforated provides a medical device-grade sterility assurance level of 10-6 and requires no rinsing prior to application.7 The graft features a wide suture border to further support intraoperative placement and ease of use in breast reconstruction.

Introducing the No Red Breast Guarantee

Recent findings have demonstrated that the use of Dermacell Acellular Dermal Matrix in immediate breast reconstruction has advantages over AlloDerm Ready-To-Use (RTU), including a significantly lower incidence of red breast syndrome. (0% vs 26%, p=0.0001).8

Based on this as well as other compelling research, we are proud to officially introduce the No Red Breast Guarantee. In the event that red breast syndrome occurs in a patient within 40 days of the original procedure date, NOVADAQ will grant a credit for the tissue provided that proof of red breast syndrome can be documented and no clinical indicators of an underlying infection were present.

Click here to download the terms and conditions of the No Red Breast Guarantee.

For more information on Dermacell ADM and/or the No Red Breast Guarantee, please contact us.

1. Pittman TA, Fan KL, Knapp A, Frantz S, Spear SL. Comparison of Different Acellular Dermal Matrix (ADM) in Breast Reconstruction: The 50/50 Study. Journal of Plastic and Reconstructive Surgery (2017)

Dermacell is sterile – sterility assurance level (SAL) 10-6 and ready to use – no rinsing required.

Dermacell is decellularized using Matracell, a proprietary and patented technology that removes at least 97% of donor DNA without compromising the desired biomechanical structure or biochemical properties for its intended use.

After being rendered acellular, Dermacell undergoes a terminal sterilization step to ensure a Sterility Assurance Level (SAL) of 10-6

Low-dose gamma irradiation performed at ultra-low temperatures is used to reach surgical device-grade sterility, which lowers the probability of an active organism in the graft to 1 in 1,000,000 – lower than 10-3 or, a 1 in a 1,000 chance

  • All of this is achieved without compromising the desired biomechanical structures or biochemical properties (i.e. cross-linking) of the biologic matrix

Dermacell PRS

In implant breast reconstruction, surgeons utilize decellularized tissue matrices, such as Dermacell to do the following:

  • Help to define the contour and shape of the new breast
  • Create a biologic interface between mastectomy skin flaps potentially reducing the risk of infection
  • Provide supplemental reinforcement to the soft tissue

Pre-Clinical Evidence

Peer-reviewed, non-industry funded studies including Evaluation of Host Tissue Integration, Revascularization, and Cellular  Infiltration within Various Dermal Substrates reported that Dermacell was associated with the furthest cell infiltration and  migration of all acellular dermal matrices studied.1

  • Dermacell: >97% of donor DNA removed 2

A recent internal lab study found

  • AlloDerm RTU had more than 50 times the residual donor DNA content than Dermacell*
  • GraftJacket has more than 150 times the residual donor DNA content than Dermacell*
  • Dermacell had the highest degree of cellular infiltration/migration – 184% more than AlloDerm 1

Clinical Evidence

Clinical data suggests that Dermacell induces less inflammation and myofibroblasts, helps to reduce seroma and infection rates, and is safe and effective in a range of patient types including patients receiving post-operative chemotherapy and post-operative radiation.

  • Hanna et al. | Annals of Plastic Surgery (In Submission) 3
    • Matracell processed, sterilized acellular dermal matrix in implant-based  breast reconstruction: clinical and histologic outcomes
  • Dermacell may have an advantage over AlloDerm in terms of seroma and infection rates in breast reconstruction. Histologic analysis confirms Dermacell “to have desirable properties of low immunogenicity, low levels of fibrosis, and minor inflammation.”
    • Key Results:
      • Lower rates of infection and seroma in the Dermacell group, although not statistically significant.
      • No difference between groups in regard to wound separation.


Recent Article – Comparison of Different Acellular Dermal Matrix (ADM) in Breast Reconstruction: The 50/50 Study

1. Palaia D. A., Arthur K. S., Cahan A. C., Rosenberg M. H. Incidence of seromas and infections using fenestrated versus
nonfenestrated acellular dermal matrix in breast reconstructions. Plastic and Reconstructive Surgery—Global Open.
2015;3(11, article e569)
2. Wirth GA, Mowlds DS, Guidotti P, et al. Acellular dermal matrix fenestrations and their effect on breast shape.
Eur J Plast Surg. 2015:1–6.
3. Pittman TA, Fan KL, Knapp A, Frantz S, Spear SL. Comparison of Different Acellular Dermal Matrix (ADM) in Breast
Reconstruction: The 50/50 Study. Journal of Plastic and Reconstructive Surgery (2017).
4. Mowlds, D. S., A. A. Salibian, T. Scholz, K. Z. Paydar, and G. A. Wirth. “Capsular Contracture in Implant-Based Breast
Reconstruction: Examining the Role of Acellular Dermal Matrix Fenestrations.” Plastic and reconstructive surgery.
5. Data on file, LifeNet Health.
6. Gefen A, Dilmoney B. Mechanics of the normal woman’s breast. Technology and Health Care. 2007;15: 259-271. Print.
7. DermACELL Instructions For Use.
8. Pittman TA, Fan KL, Knapp A, Frantz S, Spear SL. Comparison of Different Acellular Dermal Matrix (ADM) in Breast Reconstruction: The 50/50 Study. Journal of Plastic and Reconstructive Surgery (2017)