Suture-TOOL: A suturing device for swift and standardized abdominal aponeurosis closure

Abstract

Surgeons can reduce incisional hernia formation by adhering to standardized techniques for incisional wound closure. This is often neglected by the time a long operation is to be ended and can lead to the risk of developing an incisional hernia or a wound rupture. To address this issue, a suturing machine (Suture-TOOL) was developed for swift and standardized abdominal closure. The aim was to compare the user safety, speed, and suturing quality between Suture-TOOL and manual Needle-Driver suturing. Fifteen surgeons who were specialists in surgery, urology, and gynaecology as well as surgical trainees were invited. The Suture-TOOL was presented to the surgeons who read the instructions for use before starting the test. Each surgeon closed nine 15-cm-long incisions in a human body model; six with Suture-TOOL and three with the Needle-Driver technique. Gloves were examined for puncture damage. Endpoints were suture-length/wound-length (SL/WL)-ratio, closure time, number of stitches, learning curve, and glove puncture rate. A VAS-evaluation concerning different Suture-Tool user impressions was completed. A SL/WL-ratio ≥4 was 98% for Suture-TOOL versus 69% for Needle-Driver (p<0.001). Suture time was shorter for Suture-TOOL (p<0.001). Wound stitch count was higher for Needle-Driver (p<0.013). The median SL/WL-ratio was similar between groups. The learning curve plateaued after three closures using Suture-TOOL. Two glove punctures were detected—all in the Needle-Driver group. Suture-TOOL received high VAS scores for all measured functionalities. Suture-TOOL is a promising device for clinical use. It is safe, easy, and fast resulting in a high-quality suture lines with a short learning curve and a high functionality ranking.