Abstract:

BACKGROUND: Previous studies have showed that temperature-responsive hydroxybutyl chitosan has a good biocompatibility, extremely low toxicity, and good biodegradability.
OBJECTIVE: To evaluate the efficacy of a novel biomaterial, temperature-responsive hydroxybutyl chitosan, in the prevention of postoperative cerebrospinal fluid leakage.
METHODS: The basic mechanical properties of temperature-responsive hydroxybutyl chitosan at 1.5%, 2.0%, 3.0% were measured by rheometer and dynamic mechanical instrument, including gelation time, mechanical strength, and anti-fatigue property. Ten macaques were selected to prepare animal models of cerebrospinal fluid leakage, and then randomly divided into experimental and control groups. Temperature-responsive hydroxybutyl chitosan at 1.5% was used in the experimental group and nothing in the control group.
RESULTS AND CONCLUSION: The gelation time of temperature-responsive hydroxybutyl chitosan at 1.5% was (70±4) seconds, and the max sustainable pressure was 50.3-60.1 kPa, which showed excellent stability in the fatigue tests and frequency scanning. The gelation time of samples at 2% was (45±3) seconds, and the max sustainable pressure was 70.6-122.5 kPa, which failed to pass the fatigue test, but showed excellent stability in frequency scanning. The gelation time of temperature-responsive hydroxybutyl chitosan at 3% was (26±2) seconds, and the max sustainable pressure was 77.8-104.7 kPa. Likewise, the temperature-responsive hydroxybutyl chitosan at 3% with excellent stability in frequency scanning also failed to pass the fatigue test. The plugging rate was 100% in the experimental group, but 0 in the control group. Therefore, the temperature-responsive hydroxybutyl chitosan at 1.5% is most suitable for clinical application that confirmed by the animal studies of macaques in prevention of cerebrospinal fluid leakage.