Background: The increasing number of newborns requiring intubation and artificial ventilation in the sophisticated premature and intensive care units of recent years has been followed by a concomitant increase in the number of children who develop tracheal stenosis as a sequela of prolonged intubation, with a consequent increasing need for tracheal surgical repair. This study was designed to evaluate the ability of a new tissue-engineered biodegradable membrane to tightly seal significant tracheal defects.
Materials and methods: A surgically induced tracheal defect of 10 x 5 mm was repaired in rabbits using the NVR-7 membrane--a cross-linked copolymer derived from a dextran sulphate gelatin construct. The unique features of this new membrane are biocompatibility, biodegradability, elasticity, and suturability, as well as a smooth sterilization process. The animals were sacrificed and the tracheas examined at 2, 3, 4, and 8 weeks postsurgery.
Results: Seven (7) of 8 rabbits undergoing tracheal surgery survived, with a tight air seal and an almost normal airway. Macroscopic and microscopic studies of the removed specimens showed variable degrees of immunogenic reaction toward the membrane. In the long term (2-3 months), a complete regeneration of all the tracheal layers occurred, simulating the original structure and orderly arrangement of a normal trachea.
Conclusions: The surgical correction using the above membrane enabled the operated animals to overcome any respiratory distress, adequately correcting the induced tracheal defect. From this experimental study, we conclude that the new NVR-7 membrane appears to be a promising therapeutic adjunct in the treatment of patients with tracheal defects.