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This page describes products and general use; it is not medical advice.
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Short answer
Puracol Plus is a sterile wound dressing of 100% native bovine dermal collagen configured as a porous microscaffold. Cleared under FDA 510(k) K060456 (product code KGN), it manages stalled partial- and full-thickness exuding wounds by binding destructive matrix metalloproteinases and supporting tissue granulation. It requires a compatible secondary dressing.
Definition and scope
Puracol Plus is an advanced wound dressing manufactured by Medline Industries, Inc., cleared under FDA 510(k) K060456 as an unclassified device under product code KGN (“Wound Dressing With Animal-Derived Material(S)”) by the General and Plastic Surgery panel.
The dressing consists of pure bovine dermal collagen preserving its natural triple-helix structure (high nativity). Unlike denatured gelatin or hydrolyzed powders, native collagen retains intact fibrillar architecture. Puracol Plus is indicated for exuding chronic wounds, pressure ulcers, diabetic ulcers, surgical dehiscence, donor sites, and wound bed preparation.
Procurement teams distinguish standard Puracol Plus from Puracol Plus Ag+. Standard Puracol Plus contains pure bovine collagen without antimicrobials, whereas Puracol Plus Ag+ incorporates silver chloride under FDA product code FRO (“Dressing, Wound, Drug”, 510(k) K071552).
How it works or how it is used in practice
Puracol Plus operates through biochemical protease modulation and physical contact guidance in exuding wounds.
Chronic wounds show elevated Matrix Metalloproteinases (MMP-1, MMP-2, MMP-8, MMP-9) and elastase that degrade extracellular matrix and growth factors. When applied, native collagen acts as a sacrificial substrate: excess MMPs bind to and break down dressing collagen fibres, sparing host tissue.
Concurrently, the MicroScaffold porous structure provides physical guidance for migrating fibroblasts, keratinocytes, and capillary buds. Upon absorbing exudate, the sheet hydrates into a conformable moist gel that maintains direct contact and biodegrades over several days, avoiding mechanical trauma during dressing changes.
Manufacturer Instructions for Use (IFU) specify standard handling principles:
- Preparation: Cleanse with saline and debride non-viable tissue; collagen cannot interact with dry necrotic eschar.
- Hydration: On minimally exuding wounds, moisten lightly with saline; on moderate exudate, apply dry.
- Placement: Cut sheets to fit wound margins without overlapping intact skin. Loosely layer rope or cut pieces into cavity dead spaces.
- Secondary Cover: Puracol Plus is a primary contact layer without adhesive borders. Secure with an absorbent silicone foam wound dressing or a transparent film dressing for wounds.
- Wear Time: Change every 1 to 7 days based on exudate rate and secondary dressing condition.
Types or related concepts
Puracol Plus is supplied in flat sheets, fenestrated sheets for fluid transfer, and ropes for cavity packing. Sourced Medline catalog numbers and Healthcare Common Procedure Coding System (HCPCS) codes align with dressing dimensions.
Table 1: Puracol Plus Specifications and HCPCS Codes
| Item Number | Format | Dimensions | HCPCS Code | Primary Sourced Clinical Application |
|---|---|---|---|---|
| MSC8622EP | Flat Sheet | 2 in. x 2.25 in. (4.5 sq. in.) | A6021 | Partial- and full-thickness ulcers; donor sites and abrasions. |
| MSC8622EPF | Fenestrated Sheet | 2 in. x 2.25 in. (4.5 sq. in.) | A6021 | Exuding shallow wounds; fenestrations direct fluid into secondary foam. |
| MSC8644EP | Flat Sheet | 4.25 in. x 4.5 in. (19.1 sq. in.) | A6022 | Large pressure ulcers, dehisced surgical wounds, and venous ulcers. |
| MSC8644EPF | Fenestrated Sheet | 4.25 in. x 4.5 in. (19.1 sq. in.) | A6022 | Large exuding wounds requiring fluid transfer to secondary covers. |
| MSC861X8EP | Rope | 1 in. x 8 in. (8.0 sq. in.) | A6021 | Undermined wound pockets, sinus tracts, and tunneling cavity wounds. |
| MSC8722EP | Puracol Plus Ag+ | 2 in. x 2.25 in. (4.5 sq. in.) | A6021 | Colonized wounds; contains silver chloride (FDA code FRO, K071552). |
To differentiate microscaffold collagen, clinical buyers compare it against an antimicrobial collagen silver dressing, an absorbent hydrofiber wound dressing, or gelatin sponges.
Table 2: Native Microscaffold vs. Alternative Collagen Technologies
| Feature | Puracol Plus (Native Microscaffold) | Denatured Gelatin Sponges | Hydrolyzed Collagen Powders |
|---|---|---|---|
| Structure | 100% native triple-helix bovine collagen | Thermally denatured collagen | Enzymatically fragmented peptides |
| Persistence | 3D porous structure lasting days | Collapses rapidly upon wetting | Dissolves into suspension in hours |
| MMP Binding | High avidity binding to MMPs | Moderate non-specific uptake | Transient binding before wash-out |
| Guidance | 3D migratory scaffold for fibroblasts | Minimal structural guidance | No directional scaffolding |
| Cavities | Cohesive rope allows easy retrieval | Difficult to retrieve once liquefied | Unsuitable for tunneling tracts |
Where it matters for labs, clinics or supply decisions
Procurement teams and clinical researchers evaluate Puracol Plus across Medicare reimbursement rules, secondary dressing pairing, and storage requirements.
Under Medicare Part B, DME MAC LCD L33831 and Policy Article A54563 restrict coverage to full-thickness wounds (Stage 3 or 4 pressure ulcers, neuropathic ulcers, or venous ulcers) with light to moderate exudate and documented failure to progress. They are not covered for dry wounds or third-degree burns.
HCPCS billing relies on surface area tiers verified by the Pricing, Data Analysis, and Coding (PDAC) contractor:
- HCPCS A6021: Sterile collagen pads up to 16 sq. in. (includes 2 in. x 2.25 in. sheets and 1 in. x 8 in. ropes).
- HCPCS A6022: Sterile collagen pads over 16 sq. in. up to 48 sq. in. (includes 4.25 in. x 4.5 in. sheets).
When sourcing from medical wound care suppliers, buyers must verify current PDAC listing. In clinical trials, researchers use Puracol Plus to standardize primary contact layers. For heavy drainage, fenestrated sheets paired with a secondary non-stick sterile dressing prevent maceration.
Storage requires controlled room temperature between 59°F and 86°F (15°C to 30°C). Product pouches are sterile, single-use, and latex-free.
Common misunderstandings
Common clinical and supply misunderstandings include:
- Treating it as a standalone dressing: Puracol Plus lacks adhesive borders or moisture barriers; it always requires a secondary dressing.
- Confusing standard Puracol Plus with Ag+: Standard Puracol Plus contains no antimicrobials and does not treat active bioburden alone.
- Aggressively debriding the gel: The hydrated collagen gel sheet should not be scrubbed away; gentle saline rinsing is sufficient.
- Applying to dry eschar or third-degree burns: Collagen requires fluid to activate and is contraindicated on third-degree burns and active vasculitis (FDA K060456).
- Assuming latex content: While animal-derived, it is manufactured without natural rubber latex, though contraindicated in bovine allergies.
FAQ
What is the difference between Puracol Plus and Puracol Plus Ag+?
Standard Puracol Plus consists of 100% native bovine collagen without antimicrobial agents (FDA code KGN, K060456). Puracol Plus Ag+ adds silver chloride to provide an antimicrobial barrier for colonized wounds (FDA code FRO, K071552).
What HCPCS code applies to Puracol Plus?
The 2 in. x 2.25 in. sheets and 1 in. x 8 in. ropes bill under HCPCS code A6021. The 4.25 in. x 4.5 in. sheets bill under HCPCS code A6022.
Is Puracol Plus cleared for over-the-counter or prescription use?
Under FDA clearance K060456, Medline Collagen Wound Dressing received over-the-counter marketing clearance pursuant to 21 CFR 801.109, though clinics typically apply it under professional supervision.
How long can Puracol Plus remain on a wound?
Puracol Plus can remain in place for up to 7 days, depending on exudate volume and secondary cover status. Secondary layers may be replaced while leaving intact collagen gel in place.
Does Puracol Plus contain natural rubber latex?
No. Puracol Plus is not made with natural rubber latex. It is contraindicated in patients with known sensitivity to bovine collagen.
Sources
- U.S. FDA. 510(k) Premarket Notification K060456: Medline Collagen Wound Dressing. Rockville, MD: CDRH; cleared June 19, 2006. URL: https://www.accessdata.fda.gov/cdrh_docs/pdf6/K060456.pdf (accessed 2026-11-09).
- U.S. FDA. 510(k) Premarket Notification K071552: Puracol Plus Ag MicroScaffold Wound Dressing. Rockville, MD: CDRH; cleared April 25, 2008. URL: https://www.accessdata.fda.gov/cdrh_docs/pdf7/K071552.pdf (accessed 2026-11-09).
- U.S. FDA. Product Classification Database: Product Code KGN. Silver Spring, MD: CDRH; 2026. URL: https://api.fda.gov/device/classification.json?search=product_code:KGN (accessed 2026-11-09).
- Medline Industries, Inc. Puracol Plus Collagen Wound Dressings: Product Specifications and IFU. Mundelein, IL; 2026. URL: https://www.medline.com/jump/product/x/Z05-PF00078 (accessed 2026-11-09).
- CMS. Local Coverage Determination (LCD): Surgical Dressings (L33831) and Policy Article (A54563). Baltimore, MD: DME MAC Guidelines; 2026. URL: https://www.cms.gov/medicare-coverage-database/view/lcd.aspx?lcdid=33831 (accessed 2026-11-09).
