A precision-designed gastrostomy button securement device.

ABSTRACT

BACKGROUND: Gastrostomy buttons (g-buttons) are commonly placed in children to facilitate weight gain, correct nutritional deficiencies, and provide hydration and/or medication delivery. At our institution, parents are taught to place a gauze sponge under their child's g-button and secure it with strips of tape; however, the g-button still moves in the tract, which delays wound healing and leads to a variety of tract-related complications. We viewed this universal problem as a challenge and a prime opportunity for innovation. METHODS: In 2016, a pediatric surgeon and a team of graduate engineering students outlined the problem, created a list of design requirements, and began to iterate on a variety of device designs. RESULTS: Over 400 design ideas were iterated upon to various degrees. The first prototype was studied in a small clinical trial, in which 80% of caregivers reported satisfaction with the design, but 90% noted difficulty connecting the extension feeding tube. A second-generation prototype was developed, which included a reusable lid and disposable base layer. Third- generation prototypes added "edge-grippers" to facilitate attaching the extension tubing, plus pre-cut absorbent, sterile gauze pads to fit around the stem of the g-button. Finally, in 2020, the design was finalized with the addition of a childproof hinge between the lid and base layer. CONCLUSIONS: An intuitive g-button securement device was created to simplify daily gauze replacement, reduce tract-related complications, and lower the cost of care. A randomized controlled trial comparing the securement device to the "tic-tac-toe" dressing will begin in early 2022 with results available later this year.