Efficacy, adhesive properties, skin damage – examination of wound care products with established and standardized methods.
Primarily healing wounds, secondarily healing wounds, chronic wounds – appropriate wound care concepts exist for the most diverse needs. We can prove the efficacy of wound healing products with a variety of wound healing models. Our offering for the investigation of skin protection products is equally diverse. In addition, if the dressings contain an adhesive coating, it is useful to determine the adhesive properties of the product on the skin and to investigate whether the removal of the product causes damage to the skin.
In the following methods and models for the investigation of wound and skin protection products, we offer a variety of parameters for evaluation, such as healing kinetics, wound circumference / area, wound contraction, redness, transepidermal water loss, pain, etc.
In Dermatology, Oral Care, Ophthalmology, Hair Care, Women’s Health and Sun Care
The abrasive wound model allows to investigate the wound healing properties of a test product. For that purpose standardized superficial wounds are induced by means of abrasion using an autoclaved brush. Afterwards the product is applied for a period of about 14 days. Wound healing efficacy is documented by means of digital photography and visual scoring.
Primary parameter in this model is the size of the wound documented over the course of the application period by means of digital photography. The image acquisition is most often realized with systems developed by proDERM such as the proDERM MacIS (Macroscopic Imaging System) and the proDERM HiRIS (High Resolution Imaging System). The in-house developed systems combine commercially available components like high-quality cameras in a way that standardization, reproducibility and color fidelity are maximized compared to conventional imaging products.
For the determination of the wound size another in-house developed innovation is applied: An evaluation software which allows an automatic wound size calculation. All wound images with corresponding wound areas can be provided as a PDF document once the study is finalized.
The ‘suction blister’ model is an alternative method to investigate the wound healing properties of a test product. The main difference to the abrasive wound model is the way the wound is induced. Suction blisters are generated on test areas with a vacuum device featuring suction chambers. Within the chambers an initial minor negative pressure is converted after half an hour into a higher negative pressure.
After one to three hours of continuing negative pressure a suction blister sized 0.6 cm in diameter is generated. Since the epidermal layer is completely separated from the basal layer a highly standardized wound occurs once the blister roof is removed. Following wound induction the application phase starts with the corresponding photographic documentation of the wound. Likewise in the abrasive wound model the proDERM systems MacIS and HiRIS are most often applied (see clinical photography). The determination of the wound size over time allows evaluating the wound healing properties of the product.
The determination of the adhesive properties is an important parameter for manufacturers of patches, tapes, transdermal systems etc. Even though the measurement itself is described in a DIN Norm (DIN EN 1939), the method described does only allow very limited conclusion for adhesive properties on skin. This is due to the fact that within the DIN method the products are not applied on skin but on metal.
With the method ‘Adhesive Forces on Skin’ we offer a an in-vivo method on human skin. The products are applied to specific areas on the back of the volunteer and then instrumentally removed while documenting the force needed for removal. Afterwards the water content in the skin will be determined.
The removal of adhesive wound care products may cause unwanted effects. Patients may suffer from pain. The upper skin layer may be removed unintentionally und thus lead to skin irritation and skin inflammation. The degree of these unwanted effects depends on the adhesive system of the wound care product. Manufacturers of adhesive wound care products retrieve highly valuable information through the examination of unwanted effects induced by their product. There are several parameters reflecting the potential of a product to cause skin irritation or skin damage.
You can request our FactSheet on “Wound Healing” using our contact form.