Evidence in Focus
The technology and biology behind OASIS Matrix products have been well studied, with over 1500 publications about the technology and more than 500 publications on clinical application.
Proven results across a range of wounds
In multiple clinical trials, OASIS Matrix products have demonstrated:
On diabetic foot ulcers: When used with standard of care (SoC), OASIS Wound Matrix was four times less costly than Dermagraft® over 12 weeks.*1
On chronic vascular ulcers: Wound closure was achieved in 80% of ulcers treated with OASIS Wound Matrix and SoC at 8 weeks, compared to 65% in petrolatum-treated ulcers.2 The time until complete healing with OASIS Wound Matrix and SoC was 5.4 weeks compared to 8.3 weeks for wounds treated with only moist dressings (petrolatum-impregnated gauze).**2
On pressure ulcers: 40% of patients achieved complete wound healing with OASIS Wound Matrix and SoC, compared to 29% with SoC alone.3 A 90% ulcer surface area reduction was achieved for 55% of the OASIS Wound Matrix and SoC group, compared to 38% of patients for SoC alone.***3
On venous leg ulcers: Patients treated with OASIS Wound Matrix and SoC were more than twice as likely to achieve full epithelialization at 12 weeks. Wound closure was achieved in 55% of patients, compared to 34% with SoC alone.****4
At 6-month follow-up, 100% of wounds treated with OASIS Wound Matrix and SoC remained closed, compared to 70% with SoC alone.*****4
On chronic tunneling wounds: in a case-study, OASIS MICRO - applied weekly and with daily hyperbaric oxygen therapy (covered with a non-adherent ALLEVYN◊ Border foam dressing) - achieved a wound depth reduction each week until progressing to full closure after 3 weeks.******
Greater efficacy than standard care alone
- OASIS ULTRA Tri-Layer Matrix achieved 54% wound closure in diabetic foot ulcers (DFUs), compared to 32% with standard care. *******5
- OASIS ULTRA Tri-Layer Matrix showed a significantly greater DFU wound area reduction at each visit from week 1, compared to standard care.*******5
For more clinical evidence on advanced wound management, visit Education+Evidence
Helping you get CLOSER TO ZERO◊ human and economic consequence of wounds.6
*See references for full definition of standard of care. Wound closure p=0.021. Cost analysis based on cost of materials in 2008.
** See references for full definition of standard of care. Wound closure p<0.05. Treatment time to complete wound healing p=0.02.
*** See references for full definition of standard of care. Wound healing p=0.111, ulcer surface area p=0.037.
****OASIS Matrix with standard care (n=62) versus standard care alone (n=58). P<0.0196. Standard care in both groups included wound cleansing, debridement (as clinically necessary at the discretion of the investigator), dressing changes and compression therapy. Study was not blinded and establishment of a venous disease before enrolment was not always confirmed with duplex imaging. Epithelialization based on an odds ratio calculation from a 12-week clinical trial. See reference for more information.
*****Population of patients in follow-up was too small to determine statistical significance. Of the 54 patients followed at 6 months, 29 had achieved full wound epithelialization within the 12 week study period, with 19 patients in the treatment group vs. 10 in SOC alone.
******Smith+Nephew case study file. 62 year-old female with a chronic tunneling wound to the anterior chest wall of 4-month duration (0.2cm x 0.2cm x 2.3cm), with moderate exudate and no active infection. Prior treatments included weekly debridement and fluid management, negative pressure wound therapy, and daily hyperbaric oxygen therapy for 2 weeks.
*******OASIS ULTRA group (n=41) versus standard care (n=41) p<0.05. Standard care was selected by the investigator and included debridement of necrotic tissue, infection control, off-loading and maintenance of a moist wound environment. Study was not blinded.
INTENDED USE: OASIS® Matrix and OASIS MICRO are indicated for the management of wounds including: partial- and full-thickness wounds, pressure ulcers, venous ulcers, chronic vascular ulcers, tunneled and/or undermined wounds, diabetic ulcers, trauma wounds (abrasions, lacerations, second-degree burns, skin tears), draining wounds, surgical wounds (donor sites/grafts, post-Mohs surgery, post-laser surgery, podiatric, wound dehiscence).
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.
PRECAUTION: OASIS® Matrix and OASIS MICRO should not be applied until excessive exudate, bleeding, acute swelling, and infection are 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.
Dermagraft® is a trademark of Organogenesis, Inc.
References:
1. Landsman A, Roukis TS, DeFronzo DJ, Agnew P, Petranto RD, Surprenant M. Living cells or collagen matrix: Which is more beneficial in the treatment of diabetic foot ulcers? Wounds. 2008;20(5):111-116.
2. Romanelli M, Dini V, Bertone MS. 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. 2010;23(1):34-38.
3. Brown-Etris M, Milne CT., Hodde JP. An extracellular matrix graft (OASIS wound matrix) for treating full-thickness pressure ulcers: A randomized clinical trial. J Tissue Viability. 2019;28(1):21-26.
4. Mostow EN, Haraway GD, Dalsing M, Hodde JP, King D; OASIS® Venus Ulcer Study Group. Effectiveness of an extracellular matrix graft (OASIS® Wound Matrix) in the treatment of chronic leg ulcers: a randomized clinical trial. J Vasc Surg. 2005;41(5):837-843.
5. Cazzell SM, Lange DL, Dickerson JE, Slade HB. The management of diabetic foot ulcers with porcine small intestine submucosa tri-layer matrix: a randomized controlled trial. Adv Wound Care. 2015;4(12):711-718.
6. Nherera LM, Romanelli M, Trueman P, Dini V. An Overview of Clinical and Health Economic Evidence Regarding Porcine Small Intestine Submucosa Extracellular Matrix in the Management of Chronic Wounds and Burns. Ostomy Wound Manage. 2017;63(12):38-47.