Consideration of the relevance of in vitro cytotoxicity results in standard and modified tests on wound dressings

Client

A supplier of wound dressings.

Background

Extracts of a superabsorbent wound dressing prepared by standard ISO procedures produced some evidence of cytotoxicity in vitro. No such effect was seen for an extract produced by a modified procedure, and extracts did not induce in vivo skin irritation. To clarify the possible relevance of the positive results to damaged skin, the client commissioned an in vivo wound-healing study, and supplied the results to bibra.

Project Goals

Bibra was asked to evaluate the relevance of the in vitro cytotoxicity data given that 1) no adverse effects were seen in vivo in the wound-healing and skin irritation studies, and 2) the dressing is superabsorbent, a property that may influence in vitro cytotoxicity tests.

Approach

Bibra evaluated the in vitro and in vivo test results, weighing up their relevance to patients using the dressing.

Project Outcome

The report was successfully completed and provided to the client. It was concluded that the in vivo test results were more representative of real life, and reassuring for patients; in vitro cytotoxicity assays remain a valuable, health-precautionary screen.

Project Team

Beth O’Connell

Pete Watts

 

Medical Devices

More recent work Info about us Meet our team