Wound Healing

Devices used to treat wounds are as varied as are wound conditions. A wound can be surgically induced, or it can be the result of trauma or a chronic condition such as a diabetic ulcer. The extent of the wound to be treated can therefore range from a simple scratch, to a burn of varying degrees, to a deep wound that breaches multiple layers of tissue and even bone.

Standards and Regulation

The investigator must take into account the biological category as indicated by ISO 10993-1 and whether the device is a solid material or liquid. Consideration also needs to be given to adhesives that may only contact areas around the wound.

NOTE: This list provides an overview of tests to consider for wound healing devices—our technical specialists and scientists will partner with you to develop specific, cost-effective test programs that minimize your time to market.

Research and Development Support

Materials Characterization
- Thorough chemical characterization of potential leached chemicals and degradation products; obtainment of background information or data on all ingredients included in the final device, as such products may degrade during wound exposure

Efficacy
- Wound healing study using a variety of laboratory models (full and partial skin thickness)
- Special models to evaluate treatment under clinical-like conditions such as diabetic models and superficial burns
- Evaluation of wound treatments with growth factors incorporated in the material or as a liquid treatment
- Treatment of sutured and unsutured surgical wounds

Non-Clinical Testing

Biocompatibility
- Cytotoxicity by MEM elution for solid materials and by agar overlay for liquid treatments
- Sensitization by repeated patch tests or extraction models
- Intracutaneous irritation of aqueous and non-aqueous extracts
- Acute systemic toxicity of aqueous and non-aqueous extracts

Post-market Support

Sterilization validation
Environmental monitoring
Packaging validation and shelf life testing

Additional Testing

Repeated application study
Subcutaneous or muscle implant study
Series of genotoxicity assays
Systemic toxicity study

Note: This list provides an overview—our technical specialists and scientists will partner with you to develop specific, cost-effective test programs that minimize your time to market.