• 1.

    Bello, YM, AF Falabella, and WH Eaglstein. :Tissue-engineered skin: current status in wound healing. .Am J Clin Dermatol 2::305. ,2001. .

  • 2.

    Brem, H, J Balledux, T Bloom, et al. :Healing of diabetic foot ulcers and pressure ulcers with human skin equivalent: a new paradigm in wound healing. .Arch Surg 135::627. ,2000. .

    • Crossref
    • PubMed
    • Search Google Scholar
    • Export Citation
  • 3.

    Edmonds, M . :Apligraf in the treatment of neuropathic diabetic foot ulcers. .Int J Low Extrem Wounds 8::11. ,2009. .

  • 4.

    Gentzkow, GD, SD Iwasaki, KS Hershon, et al. :Use of Dermagraft, a cultured human dermis, to treat diabetic foot ulcers. .Diabetes Care 19::350. ,1996. .

  • 5.

    Marston, WA, J Hanft, P Norwood, et al. :The efficacy and safety of Dermagraft in improving the healing of chronic diabetic foot ulcers: results of a prospective randomized trial. .Diabetes Care 26::1701. ,2003. .

    • Crossref
    • PubMed
    • Search Google Scholar
    • Export Citation
  • 6.

    Veves, A, V Falanga, DG Armstrong, et al. :Graftskin, a human skin equivalent, is effective in the management of noninfected neuropathic diabetic foot ulcers: a prospective randomized multicenter clinical trial. .Diabetes Care 24::290. ,2001. .

    • Crossref
    • PubMed
    • Search Google Scholar
    • Export Citation
  • 7.

    Falanga, V and M Sabolinski. :A bilayered living skin construct (APLIGRAF) accelerates complete closure of hard-to-heal venous ulcers. .Wound Repair Regen 7::201. ,1999. .

    • Crossref
    • PubMed
    • Search Google Scholar
    • Export Citation
  • 8.

    Advanced BioHealing Inc :Dermagraft Human Fibro-blast-Derived Dermal Substitute: Directions for Use. ,Advanced BioHealing Inc. ,Westport, CT. ,2007. .

    • Search Google Scholar
    • Export Citation
  • 9.

    Organogensis Inc :Apligraf Prescribing Information. ,Organogensis Inc. ,Canton, MA. ,March 2010. .

  • 10.

    Healthpoint Ltd/Cook Biotech Inc :OASIS Wound Matrix: Instructions for Use. ,Healthpoint Ltd. ,San Antonio, TX. ,2006. .

  • 11.

    Wright Medical Technology Inc/LifeCell Corp :GRAFT-JACKET Regenerative Tissue Matrix: Instructions for Use. ,Wright Medical Technology Inc. ,Arlington, TN. ,August 2009. .

    • Search Google Scholar
    • Export Citation
  • 12.

    Brigido, SA . :The use of an acellular dermal regenerative tissue matrix in the treatment of lower extremity wounds: a prospective 16-week pilot study. .Int Wound J 3::181. ,2006. .

    • Crossref
    • PubMed
    • Search Google Scholar
    • Export Citation
  • 13.

    Brigido, SA, SF Boc, and RC Lopez. :Effective management of major lower extremity wounds using an acellular regenerative tissue matrix: a pilot study. .Orthopedics 27 ( suppl:):s145. ,2004. .

    • Search Google Scholar
    • Export Citation
  • 14.

    Martin, BR, M Sangalang, S Wu, et al. :Outcomes of allogenic acellular matrix therapy in treatment of diabetic foot wounds: an initial experience. .Int Wound J 2::161. ,2005. .

    • Crossref
    • PubMed
    • Search Google Scholar
    • Export Citation
  • 15.

    Niezgoda, JA, CC Van Gils, RG Frykberg, et al. :Randomized clinical trial comparing OASIS Wound Matrix to Regranex Gel for diabetic ulcers. .Adv Skin Wound Care 18::258. ,2005. .

    • Crossref
    • PubMed
    • Search Google Scholar
    • Export Citation
  • 16.

    Reyzelman, A, RT Crews, JC Moore, et al. :Clinical effectiveness of an acellular dermal regenerative tissue matrix compared to standard wound management in healing diabetic foot ulcers: a prospective, randomised, multicentre study. .Int Wound J 6::196. ,2009. .

    • Crossref
    • PubMed
    • Search Google Scholar
    • Export Citation
  • 17.

    Mostow, EN, GD Haraway, M Dalsing, et al. :Effectiveness of an extracellular matrix graft (OASIS Wound Matrix) in the treatment of chronic leg ulcers: a randomized clinical trial. .J Vasc Surg 41::837. ,2005. .

    • Crossref
    • PubMed
    • Search Google Scholar
    • Export Citation
  • 18.

    Romanelli, M, V Dini, and MS Bertone. :Randomized comparison of OASIS wound matrix versus moist wound dressing in the treatment of difficult-to-heal wounds of mixed arterial/venous etiology. .Adv Skin Wound Care 23::34. ,2010. .

    • Crossref
    • PubMed
    • Search Google Scholar
    • Export Citation
  • 19.

    Cornwell, KG, A Landsman, and KS James. :Extracellular matrix biomaterials for soft tissue repair. .Clin Podiatr Med Surg 26::507. ,2009. .

  • 20.

    Valentin, JE, JS Badylak, GP McCabe, et al. :Extracellular matrix bioscaffolds for orthopaedic applications: a comparative histologic study. .J Bone Joint Surg Am 88::2673. ,2006. .

    • Crossref
    • PubMed
    • Search Google Scholar
    • Export Citation
  • 21.

    Cook, JL, DB Fox, K Kuroki, et al. :In vitro and in vivo comparison of five biomaterials used for orthopedic soft tissue augmentation. .Am J Vet Res 69::148. ,2008. .

    • Crossref
    • PubMed
    • Search Google Scholar
    • Export Citation
  • 22.

    Ruszczak, Z . :Effect of collagen matrices on dermal wound healing. .Adv Drug Deliv Rev 55::1595. ,2003. .

  • 23.

    Adzick, NS, MR Harrison, PL Glick, et al. .Comparison of fetal, newborn, and adult wound healing by histologic, enzyme-histochemical, and hydroxyproline determinations. .J Pediatr Surg 20::315. ,1985. .

    • Crossref
    • PubMed
    • Search Google Scholar
    • Export Citation
  • 24.

    Bullard, KM, MT Longaker, and HP Lorenz. :Fetal wound healing: current biology. .World J Surg 27::54. ,2003. .

  • 25.

    Longaker, MT, KS Bouhana, MR Harrison, et al. :Wound healing in the fetus: possible role for inflammatory macrophages and transforming growth factor-β iso-forms. .Wound Repair Regen 2::104. ,1994. .

    • Crossref
    • Search Google Scholar
    • Export Citation
  • 26.

    Larson, BJ, MT Longaker, and HP Lorenz. :Scarless fetal wound healing: a basic science review. .Plast Reconstr Surg 126::1172. ,2010. .

  • 27.

    Karr, JC . :Retrospective Comparison of diabetic foot ulcer and venous stasis ulcer healing outcome between a dermal repair scaffold (PriMatrix) and a bilayered living cell therapy (Apligraf). .Adv Skin Wound Care 24::119. ,2011. .

    • Crossref
    • Search Google Scholar
    • Export Citation
  • 28.

    Higgs, WR . :Repair of a fifth finger crush injury. .Wound Care Hyperbaric Med 1::9. ,2010. .

  • 29.

    Dunckel, A . :Acellular bovine-derived matrix used on a traumatic crush injury of the hand: a case study. .Ostomy Wound Manage 55::44. ,2009. .

  • 30.

    Wanitphakdeedecha, R, TM Chen, and TH Nguyen. :The use of acellular, fetal bovine dermal matrix for acute, full-thickness wounds. .J Drugs Dermatol 7::781. ,2008. .

    • PubMed
    • Search Google Scholar
    • Export Citation
  • 31.

    Higgs, WR . :Necrotizing fasciitis with delayed closure. .Wound Care Hyperbaric Med 1::8. ,2010. .

  • 32.

    Neil, J, K James, and W Lineaweaver. :Utilizing biologic assimilation of bovine fetal collagen in complex reconstruction. .Paper presented at: Annual Scientific Conference of the Southeastern Society of Plastic and Reconstructive Surgeons;June 4–8, 2011;Naples, FL.

    • Search Google Scholar
    • Export Citation
  • 33.

    Frykberg, RG, T Zgonis, DG Armstrong, et al. :Diabetic foot disorders: a clinical practice guideline (2006 revision). .J Foot Ankle Surg 45 ( suppl:):S1. ,2006. .

    • Search Google Scholar
    • Export Citation
  • 34.

    Margolis, DJ, J Kantor, and JA Berlin. :Healing of diabetic neuropathic foot ulcers receiving standard treatment. A meta-analysis. .Diabetes Care 22::692. ,1999. .

    • Crossref
    • PubMed
    • Search Google Scholar
    • Export Citation
  • 35.

    Apelqvist, J, DG Armstrong, LA Lavery, et al. :Resource utilization and economic costs of care based on a randomized trial of vacuum-assisted closure therapy in the treatment of diabetic foot wounds. .Am J Surg 195::782. ,2008. .

    • Crossref
    • PubMed
    • Search Google Scholar
    • Export Citation
  • 36.

    Driver, VR and JM De Leon. :Health economic implications for wound care and limb preservation. .J Managed Care Med 11::13. ,2008. .

  • 37.

    Redekop, WK, J McDonnell, P Verboom, et al. :The cost effectiveness of Apligraf treatment of diabetic foot ulcers. .Pharmacoeconomics 21::1171. ,2003. .

  • 38.

    Stockl, K, A Vanderplas, E Tafesse, et al. :Costs of lower-extremity ulcers among patients with diabetes. .Diabetes Care 27::2129. ,2004. .

  • 39.

    Bolton, LL, L Van Rijswijk, and FA Shaffer. :Quality wound care equals cost-effective wound care: a clinical model. .Nurs Manage 30::32. ,1996. .

    • Crossref
    • Search Google Scholar
    • Export Citation

Acellular Fetal Bovine Dermal Matrix in the Treatment of Nonhealing Wounds in Patients with Complex Comorbidities

Eric Lullove Private practice, 7301 W Palmetto Park Rd, Suite 201-C, Boca Raton, FL 33433. (E-mail: drericlullove@happyhealthyfeet.com)

Search for other papers by Eric Lullove in
Current site
Google Scholar
PubMed
Close
 DPM
Restricted access

Background:

In contrast to the narrow indications for living skin equivalents, extracellular matrix biomaterials are clinically used in a wide range of wound-healing applications. Given the breadth of possible uses, the goal of this study was to retrospectively compile and analyze the clinical application and effectiveness of an extracellular matrix biomaterial derived from fetal bovine dermis (PriMatrix; TEI Biosciences, Boston, Massachusetts) in patients treated by a single physician and monitored postsurgically in an outpatient wound care center.

Methods:

A retrospective medical record review was conducted of consecutive patients treated from January 2007 through January 2009 with meshed PriMatrix after sharp/surgical debridement and coverage with standard moist wound therapy dressings.

Results:

Twenty-nine patients and 34 wounds were compiled. All of the wounds were unresponsive to conservative treatment owing to complications, including infection, exposed bone or tendon, and other comorbidities known to delay healing. Wounds included 11 diabetic ulcers, 8 venous stasis ulcers, 10 nonhealing traumatic wounds, and 5 other chronic wounds. Thirty of 34 wounds healed, with four patients lost to follow-up. Mean time to healing for diabetic foot ulcers was 105 days with an average of 2.6 PriMatrix applications. Mean time to healing for venous, traumatic, and other chronic wounds was 74 to 82 days with an average of 1.2 to 1.4 PriMatrix applications.

Conclusions:

In patients with comorbidities known to delay healing, the implantation of PriMatrix promoted the healing and, ultimately, full reepithelialization of otherwise unresponsive wounds of varied etiology, including those with complications of infection or exposed bone or tendon. (J Am Podiatr Med Assoc 102(3): 223–232, 2012)