Top Patient Tips for Post-Application Care of PriMatrix®

When she was just 12 years old, Sallie Wilson was diagnosed with diabetes. Back in the 1970s, advancements in diabetic care were limited, which prevented Sallie from living a normal life, and she eventually had to wear an offloading boot for her diabetic foot ulcers.

PriMatrix® Dermal Repair Scaffold, a skin repair product, was used to treat Sallie’s diabetic foot ulcer, and her wound completely healed in a matter of months. Sallie always hoped to be able to wear two shoes and walk without pain.

“My life has improved a whole lot,” said Sallie after her wound healed. “I can now wear two shoes to work, go to the grocery store, travel, and do things for myself. This is the life I want to have.”

PriMatrix® is designed for the management of a broad range of wound types, including partial and full thickness wounds; pressure, diabetic, and venous ulcers; second-degree burns; surgical wounds – donor site/grafts; post-mohs surgery, post-laser surgery; podiatric, wound dehiscence; trauma wounds – abrasions; lacerations and skin tears; tunneled/undermined wounds and draining wounds.

PriMatrix® is made from bovine skin that contains collagen, an important component of skin. This skin repair product is processed and sterilized so that it can be used in humans, but it should not be used for patients with a known history of hypersensitivity to collagen or bovine products.

To increase the chances of a positive experience like that experienced by Sallie, here are four tips for post-application care:

1. Manage Your Dressings            

• • Do Not Remove Dressings

Your health care provider will provide you with instructions on your dressings. Follow instructions provided by your health care provider on how to manage your wound site.

• • Keep Your Dressings Dry

Following the application of PriMatrix®, avoid getting the dressings and surrounding area wet. When bathing, keep your wound and dressings away from water. Getting the wound area wet can lead to infection. It may also cause the PriMatrix® to detach from the wound. Call your health care provider if your dressings get wet.

2. Follow All Instructions

Be sure to follow all instructions your health care provider has given you.  Contact your health care provider with any questions or concerns.

• • Diabetic Foot Ulcer Patients

If prescribed by your health care provider, it is essential to wear your specialized footwear. It will help off-load pressure from your wound.  Placing weight on your wound may interfere with healing. It can also cause the PriMatrix® to detach from the wound.

• • Venous Leg Ulcer Patients

Always wear your compression dressing as instructed by your healthcare provider.

3. Keep All Appointments

Always keep your scheduled appointments with your healthcare provider.

4. Be Aware of Possible Infection

Contact your health care provider if you experience unusual health problems such as redness, swelling, discharge, blistering, warmth, pain around your wound, an allergic reaction, fever, chills, nausea or unusual odor of your wound.

Note: These instructions are designed to serve only as a general guideline and not to supersede health care provider’s instructions.

Glossary of Key Terms

Bovine: from or relating to cows or cattle

Chronic: lasting for a long time or constantly recurring

Collagen: part of the tissue that is important in the structure of skin

Compression Dressing: special type of bandage made with elastic type material that is wrapped around the lower leg to reduce swelling and increase blood flow

Infection: contamination of a wound, organ, or person caused by germs that have entered the body

Inflammation: a reaction to injury or infection that causes redness, swelling, warmth, and/or pain

Sterilized: to make free from bacteria

Contraindications

• PriMatrix should not be used for patients with a known history of hypersensitivity to collagen or bovine products.

Warnings and Precautions

• Do not expose to chemicals or substances other than sterile, room temperature 0.9% saline.
• Excessive heat can damage collagen. Do not hydrate in 0.9% saline warmed above room temperature. If, when hydrated, the product shrinks in size, DO NOT use the product as it may be damaged.
• PriMatrix should be used with caution in regions where an infection exists or is suspected. Treat any existing infection appropriately.
• PriMatrix should not be applied directly on third degree burns.

Potential Complications

The following complications are possible. If any of these conditions occur, the device should be removed.

• Infection
• Chronic inflammation
• Allergic reaction
• Excessive redness, pain, swelling, or blistering

Clinical Studies

PriMatrix has been found to be well tolerated in a series of published clinical studies, involving over 280 wound sites in 247 patients. These studies evaluated the use of PriMatrix in the management of diabetic foot ulcers, venous leg ulcers, pressure ulcers, as well as full and partial-thickness wounds, trauma wounds, and surgical wounds.

A recent study evaluated the use of PriMatrix in the management of diabetic foot ulcers. This study demonstrated that 76% of the subjects completing the study achieved closure of their study ulcer. The average time to healing was 53.1 days⁴. Other ulcer studies have demonstrated improved healing rates when compared to other products² as well as conservative treatments³. Additionally, the use of PriMatrix has been evaluated on chronic wounds of patients with multiple health issues. These studies demonstrate, on average, similar closure rates to that in the diabetic foot ulcer study. However, since these patients were in poorer health, the wounds took longer to close^7,9.

Use of PriMatrix was also studied in acute partial and full thickness wounds, trauma wounds, and surgical wounds. These studies demonstrated that PriMatrix becomes filled with the patient’s own cells. This creates tissue that can support wound healing or have a split-thickness skin graft placed over it in as early as seven days^1,5-10.

Some patients treated with PriMatrix experienced adverse events (health complications). The adverse events include infected ulcers, degradation of PriMatrix, occurrence of another ulcer, and admittance to the hospital unrelated to PriMatrix. Adverse events have been reported in approximately 3 out of 43,000 patients treated with PriMatrix.

PriMatrix Clinical Studies

1. Hayn E. Successful treatment of complex traumatic and surgical wounds with a foetal bovine dermal matrix. Int Wound J. 2013;11:675-80.
2. 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. 2011;24(3):119-125.
3. Kavros SJ. Acellular Fetal Bovine Dermal Matrix for Treatment of Chronic Ulcerations of the Midfoot Associated with Charcot Neuroarthropathy. Foot Ankle Spec. 2012;5(4):230-234.
4. Kavros SJ, Dutra T, Gonzalez-Cruz R, et al. The Use of PriMatrix, a Fetal Bovine Acellular Dermal Matrix, in Healing Chronic Diabetic Foot Ulcers: A Prospective Multicenter Study. Adv Skin Wound Care. 2014;27(8):356-362.
5. Kohanzedeh S, Martin MS, Lugo LM, et al. PriMatrix as an alternative to flap reconstruction. Plast Reconstr Surg 2013; 132:92.
6. Lineaweaver W, Bush K, James K. Suppression of α Smooth Muscle Actin Accumulation by Bovine Fetal Dermal Collagen Matrix in Full Thickness Skin Wounds. Ann Plast Surg. 2015;00(00):1-4.
7. Lullove EJ. Acellular Fetal Bovine Dermal Matrix in the Treatment of Nonhealing Wounds in Patients with Complex Comorbidities. J Am Podiatr Med Assoc. 2012;102(3):233-239.
8. Neill JSA, Lineaweaver WC. Tissue Response to Bovine Fetal Collagen Extracellular Matrix in Full-Thickness Skin Wounds. Am J Clin Pathol. 2013;140(2):248-252.
9. Strauss NH, Brietstein RJ. PriMatrix Dermal Repair Scaffold in the Treatment of Difficult-to-Heal Complex Wounds. Wounds. 2012;24(11):327.
10. Strong A, Bennett D, Spreen E, Adhvaryu D, Littleton J, Mencer E. Fetal Bovine Collagen Matrix in the Treatment of a Full Thickness Burn Wound: A Case Report With Long-Term Follow-Up. J Burn Care Res. 2014:1-6.

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