Significance: Current suture-based trocar port closure technologies are limited in their ease-of-use and support for wound healing. Pediatric patients undergoing laparoscopic surgery face the risk of trocar port herniation, increased operating time due to curved needle hand suturing being prone to bowel puncture, and increased wound healing time due to variable suture tension at the abdominal fascial layer. The development of this novel device supports additional pediatric abdominal wound closure indications such as female, and possibly male, pediatric inguinal hernias, umbilical hernias, and assists in the repair of recurrent congenital diaphragmatic hernias, gastroschisis, as well as single port and robotic port site defects. This device represents a superior fascial defect closure technology by validating a new scaffold design that facilitates surgical repair and tissue healing of laparoscopic port fascial defects. In alignment with the mission of NICHD, the bioabsorbable scaffold system is expected to substantially lower the risk of complications and reduce operating time for pediatric surgeons, decrease healthcare costs for payers, and improve quality of life for pediatric patients after laparoscopic procedures. The proposed project will significantly enhance the technical capability of pediatric surgeons for improved laparoscopy clinical practice. The overall project goal is to validate the bioabsorbable scaffold device concept for the rapid and safe tension-free closure of pediatric laparoscopic port fascial defects in Phase I. Hypothesis: We hypothesize that FAStlink scaffolds will enable more consistent and rapid closure of pediatric port fascial defects with improved safety as compared to needle-based suturing techniques. Preliminary Data: Using initial FAStlink prototypes in large animal necropsy models, we successfully demonstrated port fascial defect edge engagement in 10 and 12-mm trocar sites. All secured fascial defect sites did not prolapse while being observed or hand stretched.
Specific Aims :
The aims are to investigate suitable scaffold geometries and material/mechanical properties to enable secure and rapid closure of port fascial defects. Rapid deployment and engagement of the device system will be evaluated by iterating 3D engineering prototypes. Secure and safe tissue fixation will be evaluated by tensile strength testing of defect closures with select scaffold geometries, and by histological evaluation of wound healing response at fascial defect sites using in vivo chronic animal models. Overall Impact: Together, these studies will demonstrate the feasibility of bioabsorbable FAStlink scaffolds for pediatric laparoscopic trocar port fascial defect closures, and accelerate the commercialization of a superior pediatric defect closure technology for clinical use.
Hand suturing of pediatric laparoscopic residual port fascial defects with straight and curved needles is time- consuming, prone to bowel puncture, and subject to post-operative complications such as hernias, infection, and bowel obstruction. The practice of ?blind? hand suturing under variable tension and without assurances of anatomic fascial defect edge alignment can lead to extended wound healing time, weaker fascial tissue strength, and higher incidence of costly post-operative complications. The development of a bioabsorbable scaffold system for tension- free port fascial defect closure will greatly facilitate repair and tissue healing in support of a rapidly growing adoption of pediatric laparoscopic procedures.
