References

  1. Hodde JP, Allam R. Small intestinal submucosa wound matrix for chronic wound healing. 2007;19(6):157-162.
  2. Clark RA. Fibrin and wound healing. Ann NY Acad Sci. 2001; 936:355-367.
  3. McPherson TB, Badylak SF. Characterization of fibronectin derived from porcine small intestinal submucosa. Tissue Eng. 1998;4:75-83.
  4. Hodde J, Janis A, Hiles M. Effects of sterilization on an extracellular matrix scaffold: part II. Bioactivity and matrix interaction. J Mater Sci Mater Med. 2007;18(4):545-550.
  5. Voytik-Harbin SL, Brightman AO, Kraine MR, et al. Identification of extractable growth factors from small intestinal submucosa. J Cell Biochem. 1997;67(4):478-491.
  6. Hodde J, Janis A, Ernst D, et al. Effects of sterilization on an extracellular matrix scaffold: Part I. Composition and matrix architecture. J Mater Sci Mater Med. 2007;18(4):537-543.
  7. Internal Cook Biotech Document: 97-010 VIIIA.
  8. Internal Cook Biotech Document: 97:010 VIIIB.
  9. Internal Cook Biotech Document: 10-040.
  10. Internal Cook Biotech Document: 97-033.
  11. Clark RA. Basics of cutaneous wound repair. J Dermatol Surg Oncol. 1993;19(8):693-706.
  12. McDevitt CA, Wildey GM, Cutrone RM. Transforming growth factor-beta 1 in a sterilized tissue derived from the pig small intestine submucosa. J Biomed Mater Res Part A. 2003;67:637-640.
  13. Internal Cook Biotech document: D00195865.
  14. Nihsen ES, Johnson CE, Hiles MC. Bioactivity of small intestinal submucosa and oxidized regenerated cellulose/collagen. Adv Skin Wound Care. 2008;21(10):479-486.
  15. Franklin ME Jr, Treviño JM, Portillo G, et al. The use of porcine small intestinal submucosa as a prosthetic material for laparoscopic hernia repair in infected and potentially contaminated fields: long-term follow-up. Surg Endosc. 2008;22(9):1941-1946.
  16. Badylak S, Kokini K, Tullius B, et al. Strength over time of a resorbable bioscaffold for body wall repair in a dog model. J Surg Res. 2001;99(2):282-287.
  17. Hiles M, Record Ritchie RD, Altizer AM. Are biologic grafts effective for hernia repair?: a systematic review of the literature. Surg Innov. 2009;16(1):26-37.
  18. Gupta A, Zahriya K, Mullens PL, Salmassi S, Keshishian A. Ventral Herniorrhaphy: Experience with Two Different Biosynthetic Mesh Materials, Surgisis and Alloderm. 2006;10(5):419-425.
  19. Kissane NA, Itani KMF. A Decade of Ventral Incisional Hernia Repairs with Biologic Acellular Dermal Matrix: What Have We Learned? Plast Reconstr Surg.2012;130(5 Suppl 2):194S-202S.
  20. Novitsky YW, Rosen MJ. The biology of biologics: basic science and clinical concepts. Plast Reconstr Surg. 2012;130(5 Suppl 2):9S-17S.
  21. Children’s Hospital Los Angeles. Controlling cell turnover in the intestinal lining. Science Daily. https://www.sciencedaily.com/releases/2016/04/160405182950.htm. Published 05 Apr 2016. Accessed 19 Jun 2018.

OASIS® Extracellular Matrix

    Contraindications

    This device is derived from a porcine source and should not be used in patients with known sensitivity to porcine material. This device is not indicated for use in third degree burns.

    Precautions

    Do not re-sterilize. Discard all open and unused portions of the OASIS ECM. Device is sterile if the package is dry, unopened and undamaged. Do not use if the package seal is broken. The device must be used prior to the expiration date. Discard device if mishandling has caused possible damage or contamination. OASIS ECM should not be applied until excessive exudate, bleeding, acute swelling, and infection is controlled.

    Potential Complications

    The following complications are possible. If any of these conditions occur, the device should be removed: infection; chronic inflammation (Initial application of wound dressings may be associated with transient, mild, localized inflammation); allergic reaction; and excessive redness, pain, swelling, or blistering.

    Storage

    This device should be stored in a clean, dry location at room temperature.

    Sterilization

    This device has been sterilized with ethylene oxide.

    Biodesign® Hernia Graft

    Intended use

    The Cook® Biodesign® Hernia Graft is intended for implantation to reinforce soft tissues where weakness exists during ventral hernia repair. The graft is supplied sterile and is intended for one-time use. Rx ONLY This symbol means the following: CAUTION: Federal (U.S.A.) law restricts this device to sale by or on the order of a physician. MR This symbol means the following: Magnetic Resonance Safe. HERNIA GRAFT This symbol means the following: Hernia Graft. This graft is intended for use by trained medical professionals.

    Contraindications

    This graft is derived from a porcine source and should not be used in patients with known sensitivity to porcine material.

    Precautions

    This device is designed for single use only. Attempts to reprocess, resterilize, and/or reuse may lead to device failure and/or transmission of disease. Do not resterilize. Discard all open and unused portions of the graft. The graft is sterile if the package is dry, unopened and undamaged. Do not use if the package seal is broken. Discard graft if mishandling has caused possible damage or contamination, or if the graft is past its expiration date. Ensure that graft is rehydrated prior to cutting, suturing, stapling, tacking or loading of the graft laparoscopically. Ensure that all layers of the graft are secured when suturing, stapling, or tacking. Place graft in maximum possible contact with healthy, well-vascularized tissue to encourage cell ingrowth and tissue remodeling. Suturing, stapling, or tacking more than one graft together may decrease graft performance. No studies have been conducted to evaluate the reproductive impact of the clinical use of the graft. Extended rehydration or excessive handling could lead to partial delamination of superficial layers of the graft. Care should be taken when device is placed in infected wounds. Care should be taken to avoid damage to the graft when loading laparoscopically. It is recommended to load through a 10 mm or larger port. If wound is left open, keep graft moist to prevent dryness.

    Potential complications

    Possible adverse reactions with the use of biologic hernia prostheses may include: adhesion, bowel erosion, bowel obstruction, discharge, fever, fistula formation, hematoma, hernia recurrence,  infection/abscess formation, inflammation, pain, premature degradation, seroma formation, and wound dehiscence.

    See package insert for full product information.