Advanced Wound Skin Substitutes - FAQ

Skin substitutes are advanced wound care products designed to mimic the properties of natural skin. They help cover wounds, support healing, and can be made from human tissue, animal-derived materials, or synthetic substances.

Skin substitutes are typically used for chronic, non-healing wounds such as diabetic ulcers, venous leg ulcers, pressure injuries, or surgical wounds that are not responding to conventional treatment.

Skin substitutes promote healing by providing a protective barrier, encouraging new tissue growth, reducing inflammation, and improving cell regeneration at the wound site.

There are two main categories:

Biologic (Human or Animal-Derived): Includes amniotic tissue, dermal matrices, and xenografts.

Synthetic: Engineered materials that replicate skin structure and support cell attachment and healing.

Yes. All FDA-approved or FDA-regulated skin substitutes are processed under strict safety protocols to ensure sterility and compatibility. They are commonly used by wound care specialists and surgeons.

Most applications are minimally invasive and done in a clinical setting. Some patients may experience mild discomfort, but it is generally well-tolerated and often less painful than traditional wound care methods.

Many private insurance plans and Medicare do cover skin substitute applications, particularly for chronic, non-healing wounds. Coverage may vary based on your diagnosis and treatment setting. Our team can help verify your benefits.

This depends on the type of wound, its severity, and the skin substitute being used. Treatments may be administered weekly or biweekly, with progress assessed at each visit.

Yes. In most cases, skin substitutes are applied with secondary dressings to protect the wound and maintain an optimal healing environment.

If you have a wound that has not healed in 4 weeks or more despite standard care, you may be a candidate. Schedule a consultation with your wound care provider or contact our team to learn more.

Advanced Wound Skin Substitutes – Physician FAQ

Skin substitutes are biologically active or biomimetic materials designed to replace or support damaged skin. They provide a temporary or permanent matrix that facilitates re-epithelialization, angiogenesis, and extracellular matrix remodeling, ultimately accelerating wound closure in chronic or complex wounds.

Indications include diabetic foot ulcers (DFUs), venous leg ulcers (VLUs), pressure injuries, surgical or traumatic wounds, and wounds with stalled healing after 4+ weeks of standard care. Selection depends on wound etiology, depth, presence of infection, and patient comorbidities.

  • Allogeneic (e.g., human amniotic membrane, cadaveric dermis)

  • Xenogeneic (e.g., porcine or bovine dermal matrices)

  • Synthetic (e.g., collagen matrices, polymer scaffolds)

Amniotic allografts modulate inflammation, reduce scarring, promote angiogenesis, and provide a structural matrix. They contain growth factors, cytokines, and extracellular matrix proteins critical to wound healing.

Numerous randomized trials and real-world studies demonstrate increased wound closure rates, reduced time to closure, and lower recurrence rates in patients receiving advanced skin substitutes compared to standard moist wound care.

Contraindications typically include active infection at the wound site, known hypersensitivity to graft materials, or inadequate vascular supply. Proper debridement and wound bed preparation are critical to success.

Documentation must support medical necessity, including:

  • Detailed wound history and measurements

  • Failed response to 4 weeks of standard care

  • Adequate debridement

  • Presence of comorbidities (e.g., diabetes, PVD)

  • Signed and dated treatment plan, and photos where applicable

CMS typically allows weekly applications, with limitations on total number of units and frequency per anatomical site. Exact limits depend on the MAC jurisdiction. It's critical to adhere to local coverage determinations (LCDs) and A/B MAC policies.

The wound should be covered with appropriate secondary dressings to maintain moisture and protect the graft. Dressing changes are minimized for 3–7 days unless clinically indicated. Avoid trauma to the wound site during this period.

  • LCD-aligned documentation templates

  • Billing and coding assistance

  • Product education and clinical protocols

  • On-demand wound care consultations