Process Reduces Risk of Tissue Allograft Infection

The findings were presented at the annual meeting of the American Association of Orthopedic Surgeons in San Francisco (CA, USA) in March 2004.

In the study, 50 patients underwent surgery to repair a tear in the ligament that connects the thighbone to the shinbone, using Achilles tendons that had been bacterially sterilized using the new procedure, called the Clearant Process. At six months of follow-up, ease and range of motion were similar to those in patients with traditionally processed implants, indicating that the inactivation procedure does not damage the structural integrity of the tissue.

A number of new and deadly diseases such as HIV, hepatitis C, and West Nile virus have been shown to be transmissible through tissue allografts. The Clearant Process is the only current technology that can substantially reduce all types of pathogens, including bacteria and viruses, without compromising the quality of the tissue, according to Clearant, Inc. (Los Angeles, CA, USA; www.clearant.com). The company has demonstrated inactivation of both enveloped and non-enveloped viruses. The process is designed to be used for allograft tissue in the final container, thereby allowing the final product to be terminally sterilized for use in the operating room.

"By combining the Clearant Process with traditional infection control methodologies, such as donor screening and aseptic processing and cleaning, we can practically eliminate the risk of infection associated with human tissue allografts,” said Alain Delongchamp, COO of Clearant.




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