Sterile hydrocolloid dressing for chronic and superficial wounds. Interacts with wound exudate to form a protective gel that maintains a moist healing environment and lifts away cleanly without damaging new tissue. Available in Border, Standard and Thin.
| Regulatory Class | Medical Device (MDA) — confirm class |
|---|---|
| Manufacturer | EuroMed (FDA-approved facility, ISO 13485) |
| Presentations | Border, Standard, Thin |
| Outer Layer | Semipermeable polyurethane film |
| Hydrocolloid | Sodium carboxymethylcellulose (CMC) |
Product Overview
SureSkin II is a range of sterile hydrocolloid dressings for ulcers that promote local healing in a moist environment. The dressing's components interact with the wound's exudate to form a gel; the hydrocolloid is formulated so that most of the gel is removed when the dressing is changed, without damaging newly formed tissue.
Structure and Composition
- Outer layer: Semipermeable polyurethane film that allows circulation of O2, CO2 and water vapour, while excluding germs and water
- Hydrocolloid: Sodium carboxymethylcellulose (CMC)
Unique Selling Points
- Forms a protective gel that maintains a moist wound environment for faster healing
- Removes cleanly on dressing change without damaging newly formed tissue
- Semipermeable: impermeable to liquids and bacteria (lower infection risk), permeable to gases and water vapour
- High absorption capacity — in manufacturer lab testing, absorbed 5% more fluid than dressing B and 200% more than dressing A
- Three presentations (Border, Standard, Thin) for different wound types and exudate levels
Mechanism of Action
- The dressing absorbs wound fluid; the hydrocolloids swell and form a gel that covers the wound and maintains moisture
- The gel continues absorbing fluid and forms a bubble
- The gel minimises adherence to the wound; on removal the wound stays protected by a film of gel (consistency similar to pus, but should not be mistaken for it)
Indications
- Border and Standard: care of chronic wounds with mild to moderate exudation
- Thin: care of superficial ulcers with dry or mild exudation; also recommended for post-healing protection
- Suitable for pressure ulcers, vascular ulcers and superficial ulcers
Directions for Use
- Clean the wound area with normal saline or water.
- Pat dry — do not use ointments or moisturisers on the skin.
- With one hand, grasp the paper release liner at the arrows; with the other, grasp the plastic film liner.
- Turn the dressing over, centre it over the wound and press in place.
- Remove the paper liner completely and smooth in place, then remove the plastic film liner and smooth.
- Place a hand over the dressing and mould it to the skin contours.
When to Change
- A bubble appears as the dressing interacts with wound fluid; change before the bubble reaches the edge of the dressing
- Change if leaks are detected, or after a maximum of seven days / when maximum absorption is reached
- Keep in place as long as possible for best results
Specifications
| Type | Sterile hydrocolloid dressing |
|---|---|
| Presentations | Border, Standard, Thin |
| Border sizes | 2x2 in (5x5 cm), 4x4 in (10x10 cm), 6x6 in (15x15 cm), 8x8 in (20x20 cm); heel/elbow 3.5x5 in (8x12 cm); sacral 6x7 in (15x18 cm) |
| Standard sizes | 4x4 in (10x10 cm), 6x6 in (15x15 cm), 8x8 in (20x20 cm) |
| Thin sizes | 2x2 in (5x5 cm), 4x4 in (10x10 cm), 6x6 in (15x15 cm) |
| Manufacturer | EuroMed (FDA-approved facility, ISO 13485) |
| Use | External use only |
Do not use on patients with a known sensitivity to the dressing or any of its components. For external use only.
MDA registration number to be confirmed on the MDA portal (mdar.mda.gov.my) prior to publishing this product as fully registered.
