30% faster with the instrument:
First pre-clinical study was a proof-of-concept where 10 surgeons made manual needle driver incisin closures and instrument suture lines in a model. Results showed 30% faster stitching with the instrument and 95% adherence to acceptable quality compared to 30% with manual technique.
Results were presented at the Swedish surgical week 2018 and EHS Hamburg 2019. https://2018.kirurgveckan.se/las-abstracts/ https://ehs2019hamburg.com
Learning to use the instrument:
The second study investigated the learning curve. Theatre nurses, specialists in surgery and surgical trainees each made 10 suture lines with the instrument in the same bench model without prior handling the instrument. Learning curves flattened after three suture lines. The study also showed that theatre nurses without previous training in surgical stitching had no difficulty in making suture lines with the instrument.
Results were presented at the Swedish surgical week 2019.
Further studies and next steps:
We are planning two more studies. A study in autopsy setting which will compare the next iteration of the instrument with manual suturing. This study will provide information about certain ergonomic issues but foremost if the data from previous studies can be repeated in humans. Hereafter we plan a randomized clinical trial on colorectal cancer patients. This patient group is engaged in a follow-up system including multiple CT-scans wich can detect incisional hernias. A majority of incisional hernias are detected within 1 year.