Novel Design of a Three-Dimensional Printed Umbilical Cord Clamp: A Proof of Concept Study

Abstract

Parents frequently report complaints regarding the excessive size of the clamp that create concerns of hooking to the clothes and inducing premature separation of the dried cord. We aimed to design three-dimensional (3D) print and test a novel umbilical clamp which would be smaller, more ergonomic, and would look more appealing to the parents. After the design and 3D printing process, the clamps were tested for fluid leak on fresh umbilical cord specimens. The umbilical vein was cannulated with a 4F feeding tube which was attached to the saline infusion bag inserted in a pressure infusion cuff. The compressed cord width was measured, and the cuff was inflated to 100 mmHg and 200 mmHg. Umbilical cord specimens of 152 patients were included in the main study. The mean umbilical cord diameter (UCD) was 11.1 ± 3.5 mm (range: 4.5–23.3 mm). The compressed cord width mean value after clamping with the novel design clamp was 17.3 ± 2.3 mm compared to the 23.5 ± 3.5 mm with the conventional clamp and this difference was statistically significant (p < 0.001). All of the novel clamps safely and efficiently clamped the umbilical cords without any fluid leak. The novel design umbilical cord clamp is a safe and efficient tool being able to clamp a wide range of umbilical cords. However, a prospective randomized trial on human subjects, safety-efficacy tests by independent healthcare providers, and patient satisfaction surveys are mandatory for the further approval of our claims.