What it is
A skin substitute is a broad term for materials used to temporarily or longer-term cover a wound and provide a scaffold or biological environment for healing. Some are made from human tissue, some from animal sources, and some are synthetic or a combination. They come in sheets, matrices, powders and other forms.
The category is wide, and the products are not all alike. Some are meant to act as a protective covering, while others are designed to give the body's cells a framework to grow into. Names such as cellular and acellular products, dermal matrices, and amniotic or placental grafts often fall under this umbrella.
Regulatory status varies by product. Many human tissue-based products are regulated as minimally manipulated tissue rather than as FDA-approved drugs, while some others are cleared or approved as medical devices through different pathways. Coverage also differs by product and by payer, so it is worth asking a provider about both the status of a specific product and what your plan may cover.
How it’s traditionally been approached
Wound care has long started with the basics: identifying why a wound is not healing, cleaning and removing unhealthy tissue (debridement), managing moisture with dressings, relieving pressure, and addressing circulation, blood sugar, nutrition and infection. These steps are commonly looked at before more advanced options are considered.
Advanced therapies have traditionally been discussed when a wound, such as a diabetic foot ulcer, venous leg ulcer, pressure injury or surgical wound, has been slow to heal despite standard care. Options may include negative pressure wound therapy, compression, offloading devices, hyperbaric oxygen therapy for certain FDA-cleared indications, and skin substitutes.
Skin substitutes have been used in many settings, including clinics, hospitals and surgical centers. How they are chosen and used varies by clinician, wound type and patient circumstances. For further reading specifically on amniotic products, amnioticdoctors.com is an independent resource, not affiliated with WoundKare.
How the right wound care specialist may help
The right wound care specialist may help by first working out why your wound has stalled. A visit commonly includes a review of your health history and medications, a look at the wound itself, and sometimes measurements, photos or tests of circulation. This evaluation helps a clinician decide whether a skin substitute is a reasonable option or whether something else should come first.
If a skin substitute is considered, a specialist may explain what type of product it is, how it would be applied, how often follow-up visits might be needed, and what the wound bed needs to look like beforehand. They may also discuss the possibility that it does not work as hoped, because results are never guaranteed.
Questions worth asking a licensed provider include: What is causing my wound? What stage or type is it? What are my treatment options, including those that are not skin substitutes? What is the regulatory status of the product you suggest? How long might healing take? What will my insurance cover, and what might I owe? Writing these down before your visit can help.
The whole-person view
Healing involves the whole person. Chronic wounds can bring pain, poor sleep, worry, and limits on daily activities, and stress and low mood can in turn affect energy, appetite and self-care. Blood sugar, circulation, nutrition and rest also play roles, so a good care team often looks beyond the wound itself.
Some people find extra support helpful while managing a long-healing wound. Body-based approaches such as those offered through Somatic Experiences may help with tension and stress held in the body, and talk therapy through Therapists.plus may help with the emotional load of ongoing care. These are complements to, not replacements for, medical wound care.
Somatic Experiences: trauma and emotional healing →Somatic Experiences: embodiment and movement →Therapists.plus: mind body connection →
Keep in mind
- Only a licensed clinician can decide whether a skin substitute is appropriate for you after an evaluation; this page is educational and not medical advice.
- Seek medical care promptly for signs of infection such as spreading redness, red streaking, increasing warmth or pain, pus, foul odor, fever or chills, or if a wound is rapidly worsening.
- Call 911 or go to the ER for heavy bleeding, exposed bone or tendon, signs of sepsis, or a deep or severely contaminated wound. If you are in emotional crisis, call or text 988.
- Products vary in FDA status and insurance coverage, and no product comes with a guarantee of results, so ask your provider about both.
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Frequently asked questions
What is a skin substitute for wound healing?
A skin substitute for wound healing is a material, made from human tissue, animal tissue, synthetic components or a mix, that is applied to a wound to cover it and support the body's repair process. Different products are designed for different purposes. A licensed clinician decides if one is appropriate.
Are skin substitutes FDA-approved?
It depends on the product. Some are regulated as medical devices, while many human tissue-based products, including amniotic or placental grafts, are regulated as minimally manipulated tissue rather than FDA-approved drugs. Ask your provider about the specific product's regulatory status.
What kinds of wounds are skin substitutes used for?
They are commonly discussed for wounds that have been slow to heal, such as diabetic foot ulcers, venous leg ulcers, pressure injuries, burns and some surgical wounds. Whether one fits your situation depends on the cause of your wound and an in-person evaluation.
Does a skin substitute guarantee a wound will heal?
No, there is no guarantee. Healing depends on many factors, including circulation, infection, blood sugar, pressure on the area, nutrition and overall health. A specialist can explain what may be realistic for your wound.
Does insurance cover a skin substitute for wound healing?
Coverage differs by product, wound type and payer, and it often has specific requirements. Ask your provider's office and your insurer what is covered, what documentation is needed and what you may owe before starting.
What should I ask a wound care specialist about skin substitutes?
Ask what is causing your wound, how it is staged, which treatment options exist beyond skin substitutes, and what the regulatory status of any suggested product is. Also ask about expected healing time, follow-up visits and insurance coverage.
Educational resource. WoundKare shares general information and connects people with independent wound care specialists. It is not medical advice, diagnosis or treatment. Talk with a licensed professional about your health.