Decellularised split pSFT were assessed for sterility, removal of cellular material, maintenance of histological structure, total DNA content, biocompatibility and biomechanical properties.
Sterility of oSFT was tested immediately following extraction using a small piece of tissue from both the toe and ankle regions. For decellularised split pSFT, one half of the tendon was designated for QA and the other for potential use in the animal study. Sterility of pSFT was assessed following decellularisation and prior to packaging for every tendon produced. This assessment was carried out by placing a small sample of the toe region of each QA tendon in 10 ml sterile nutrient broth (Oxoid), incubated at 37 °C for 48 h and checked for signs of cloudiness or film formation. Only tendons where the QA sample showed no signs of microbial growth were used in the animal study. For all other quality assurance analyses, tissue was taken from a set of 6 QA tendon halves, which were chosen at random from the packaged tissues. As the decellularisation process had been previously established [26 (link)], it was deemed sufficient to perform checks to confirm decellularisation on a random subset of the tendons.
Sterility of oSFT was tested immediately following extraction using a small piece of tissue from both the toe and ankle regions. For decellularised split pSFT, one half of the tendon was designated for QA and the other for potential use in the animal study. Sterility of pSFT was assessed following decellularisation and prior to packaging for every tendon produced. This assessment was carried out by placing a small sample of the toe region of each QA tendon in 10 ml sterile nutrient broth (Oxoid), incubated at 37 °C for 48 h and checked for signs of cloudiness or film formation. Only tendons where the QA sample showed no signs of microbial growth were used in the animal study. For all other quality assurance analyses, tissue was taken from a set of 6 QA tendon halves, which were chosen at random from the packaged tissues. As the decellularisation process had been previously established [26 (link)], it was deemed sufficient to perform checks to confirm decellularisation on a random subset of the tendons.
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