Newsroom February 20, 2019

Study demonstrates Cook Biotech’s OASIS® Wound Matrix has higher rates of healing in pressure ulcers than standard of care

Bloomington, Ind. —  A recently published multi-center, randomized, controlled trial (RCT) demonstrated higher rates of healing when using OASIS® Wound Matrix with standard of care (SOC) for the treatment of full-thickness Stage III or Stage IV pressure ulcers than when using SOC alone.1

Pressure ulcers are open wounds caused by pressure. They often occur when an individual remains in one position for an extended period.2,3

In the United States, over two million patients are affected annually by pressure ulcers.4 Most full-thickness pressure ulcers do not close completely within 12 weeks, leading to prolonged treatments in hospitals, wound centers, long term care facilities, and home care programs.5 The prolonged care costs result in over $9 billion annually on the healthcare system.4

The study showed a statistically significant difference in healing rates during weeks four through 12 when using OASIS Wound Matrix plus SOC versus SOC alone. Over the first three weeks of treatments, both groups reduced the ulcer surface area by 35-40%. During the subsequent nine weeks, only the OASIS Wound Matrix plus SOC group progressed further, achieving an average of 66% surface-area reduction.1

At 12 weeks, 40% of patients treated with OASIS Wound Matrix plus SOC healed completely, compared to 29% who received SOC alone.   

According to lead investigator Marie Brown-Etris, “OASIS is designed to attach to the wound bed and serve as a scaffold to help guide the natural growth of new tissue. I particularly like to incorporate OASIS Wound Matrix under non-adhesive foam dressings when a wound has stalled, or I want to stimulate healing.”

The study also reported no significant difference in adverse events between the groups and concluded that OASIS Wound Matrix has an excellent safety profile.

The randomized controlled trial enrolled 130 patients across 12 sites. SOC consisted of dressing changes, wound cleansing, wound debridement, and as-needed wound coverage with isotonic gel and semi-occlusive absorbent film dressings. Patients were on pressure redistribution support surfaces.

OASIS Wound Matrix is manufactured by Cook Biotech Inc. and distributed in the United States by Smith & Nephew Inc.

OASIS® WOUND MATRIX
INTENDED USE: OASIS® Wound Matrix is indicated for the management of wounds including: • Partial and full-thickness wounds • Pressure ulcers • Venous ulcers • Chronic vascular ulcers • Tunneled, undermined wounds • Diabetic ulcers • Trauma wounds (abrasions, lacerations, second-degree burns, skin tears) • Draining wounds • Surgical wounds (donor sites/grafts, post-Mohs’ surgery, postlaser surgery, podiatric, wound dehiscence). OASIS® Wound Matrix is supplied sterile in peel-open packages and is intended for one-time use. CAUTION: Federal (U.S.A.) law restricts this device to sale by or on the order of a licensed healthcare practitioner. 

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 OASIS® Wound Matrix. • 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® Wound Matrix 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 • Excessive redness, pain, swelling, or blistering.

See package insert for full product information. EPI_FP0080-01D

About Cook Biotech
Cook Biotech Inc. develops and manufactures medical products for tissue repair and regenerative medicine applications using proprietary extracellular matrix (ECM) technologies and processes. Cook Biotech products are marketed and distributed under several brand names, including Biodesign® and OASIS®. Cook Biotech collaborates with partners and distributors, including AxoGen Inc., Aziyo Biologics, Cook Medical Inc., Cormatrix, Katena Products Inc., Keystone Dental Inc., Progressive Medical Inc., and Smith & Nephew Inc. to develop new products and provide technical support. Cook Biotech was established in 1995 and is a Cook Group company. It is located in the Purdue Research Park in West Lafayette, Indiana. For more information, visit cookbiotech.com.

References:

  1. Brown-Etris M, Milne CT, Hodde JP. An extracellular matrix graft (OASIS® wound matrix) for treating full-thickness pressure ulcers: A randomized clinical trial. Journal of Tissue Viability, https://doi.org/10.1016/j.jtv.2018.11.001.
  2. CMS Manual system. Pub. 100-07 state operations provider certification. https://www.ahcancal.org/facility_operations/Documents/SC17-36.03.Appendix%20PP%20with%20Final%20IGs.pdf.
  3. Lagana G, Anderson EH. Moisture dressings: the new standard in wound care. J Nurse Pract 2010:6(5):366-70.
  4. Are we ready for this change? https://www.ahrq.gov/professionals/systems/hospital/pressureulcertoolkit/putool1.html; 2014.
  5. Ocampo W, Cheung A, Baylis B, et al. Economic evaluations of strategies to prevent hospital-acquired pressure injuries. Adv Skin Wound Care 2017;30(7):319-33.

Marie Brown-Etris has previously been a paid consultant of Cook Biotech.