Written and maintained by CASRAI Editorial Board
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General product and regulatory information only; this page is not medical advice and does not describe how to treat any wound.
Overview: what is a collagen dressing?
A collagen dressing is a wound dressing made from collagen of animal origin. WoundSource describes the category as “sheets, pads, particle and gels derived from bovine, equine, porcine or avian sources.” The same page describes them as primary dressings and notes that some forms interact with wound exudate to form a gel.
The regulatory frame matters more than most product pages suggest. FDA files this product family under product code KGN, “Wound dressing with animal-derived material(s)”. The FDA record shows the device class as unclassified, the classification reason as pre-amendment, the submission type as 510(k), and the review panel as General and Plastic Surgery. A collagen dressing is therefore not covered by the simpler dressing rules that apply to products such as a hydrogel wound dressing, which that guide explains is defined to exclude animal-derived materials. For a collagen dressing, the product’s own labeling and instructions for use are the authority.
Types of collagen dressing
Two things vary independently: the physical form and the animal source. The table lists each as the manufacturer and trade sources name them.
| Type | What it is | Labeled limits (WoundSource) |
|---|---|---|
| Sheet or pad | A solid collagen dressing supplied as a sheet or pad. Example: Lohmann & Rauscher BIOPAD, “100% native equine Type I collagen”, a primary dressing supplied sterile and individually sealed in 5 x 5 cm (2 x 2 in.) and 10 x 10 cm (4 x 4 in.) sizes. | Collagen dressings are “generally contraindicated for dry wounds and third-degree (full-thickness) burns” and in patients with sensitivities to collagen or bovine products (WoundSource). |
| Particles | Collagen supplied as particles rather than a sheet (WoundSource category description). | Same general labeled limits as above. |
| Gel | Collagen supplied as a gel (WoundSource category description). | Same general labeled limits as above. |
| Bovine, equine, porcine or avian source | The animal the collagen comes from. BIOPAD is equine. | Sensitivity to bovine products is named as a contraindication, so the source animal is part of what a label has to state. |
How to read the labeled limits
Collagen dressings are not ranked by care setting in the published material, so this page does not rank them either. The points below are limits that the trade source and the manufacturer state about the category:
- Form and source. The form (sheet, pad, particles or gel) and the animal source (bovine, equine, porcine or avian) are the two ways the category is divided.
- Labeled exclusions. WoundSource states that collagen dressings are generally contraindicated for dry wounds and third-degree (full-thickness) burns, and should be avoided in patients with sensitivities to collagen or bovine products.
- Clinical decisions. Choosing a dressing for an individual patient is a clinician’s decision made against the manufacturer’s instructions for use.
For how a facility lists wound-care stock more broadly, see the wound care clinic supply checklist. For other dressing families, compare hydrocolloid wound care and what MEDIHONEY is.
What to check on the label
The “collagen dressing material” question is answered on the label, because FDA does not give this device group a regulation number or definition on its classification record. Check these items in the manufacturer’s labeling:
- Animal source and collagen type. BIOPAD, for example, states “100% native equine Type I collagen”.
- Sterility and packaging. BIOPAD is described as sterile and individually sealed.
- Size in both units. The BIOPAD listing gives 5 x 5 cm (2 x 2 in.) and 10 x 10 cm (4 x 4 in.).
- Units per box and per case. BIOPAD item 153355 ships 3 per box and 168 per case; item 153356 ships 1 per box and 34 per case. Item numbers and pack counts are manufacturer-specific.
- Indications and contraindications. The label states the intended wound types and the exclusions, such as dry wounds, third-degree burns and collagen or bovine sensitivity.
- Whether a secondary dressing or tape is specified. If the instructions call for one, see what medical tape is.
Care and replacement
Application, wear time and change intervals differ between products and are set by the manufacturer’s instructions for use and the treating clinician. The BIOPAD product page states no change interval, so the instructions for use of the specific product are the place to look rather than a general rule.
Frequently asked questions
What is a collagen dressing?
A wound dressing made from animal-derived collagen, supplied as sheets, pads, particles or gels, and used as a primary dressing (WoundSource).
What are the types of collagen dressing?
By form: sheets or pads, particles and gels. By source: bovine, equine, porcine or avian.
What is collagen dressing material?
Collagen of animal origin. One manufacturer example is 100% native equine Type I collagen.
Does FDA regulate collagen dressings?
FDA lists them under product code KGN, “Wound dressing with animal-derived material(s)”: unclassified, pre-amendment, 510(k), General and Plastic Surgery panel.
Is a collagen dressing supplied sterile?
It depends on the product. The BIOPAD example is described by its manufacturer as sterile and individually sealed; the label of any other product states its own sterility and packaging.
Sources
- FDA, Product Classification, code KGN, accessdata.fda.gov. Checked 2026-10-30.
- Lohmann & Rauscher, BIOPAD product page, lohmann-rauscher.com. Checked 2026-10-30.
- WoundSource, Collagens (dressings category), woundsource.com. Checked 2026-10-30.
