Building on knowledge
Abdominal wall closure
The published results indicates that the new device is working swiftly and delivers the same high performance regardless of the clinicians’ experience. Early feedback also shows that it is intuitive and is easy to handle.1
A safe standardized closure technique is achieved to minimize abdominal wall complications like wound infections, burst abdomen and incisional hernias.
It is recommended that the suture length-to-wound length (SL/WL) ratio is 4>1 and that the ratio is acquired with small stitches put tightly.2
This can be time-consuming and difficult to achieve, especially following long surgical procedures.3
To address this issue, Suture-TOOL has been developed for swift and standardized abdominal wall closure. To evaluate the device, three preclinical studies have been performed with >60 participants.
In the first two studies the device was compared to gold standard manual suturing in an animal tissue model and a human model.Results showed SL/WL ratio ≥4 of 95-98% with the device to 30-69% with manual suturing and device suturing was 30% faster.
The third study compared tissue manipulation when suturing with the device and manual needle holder. The pinching force needed to stabilize the tissue was lower when the device was used compared to manual needle holder suturing but tissue traction was similar.3
30% faster with the Suture-TOOL
The result of the study showed that in total, 80 suture lines were evaluated. SL/WL ratio of 4:1 as achieved in 95% using the Suture-TOOL and 30% using NDS. Suture time was 30% shorter using the Suture-TOOL compared to NDS.
Conclusions was that the Suture-TOOL seems to be a promising device to perform a speedy standardized high quality suture line for fascial closure.
Suture-TOOL is safe and easy to use
Result from the study: Fifteen surgeons who were specialists in surgery, urology, gynaecology, and surgical trainees participated. The Suture-TOOL was presented to the surgeons who read the instructions before starting the test. Each surgeon closed nine 15 cm-long incisions in a human body model: six with the suturing instrument and three with the NDS technique. Endpoints were SL/WL-ratio, closure time, number of stitches, learning curve, and glove puncture rate.
Results from the previous study was repeated in the human body model: adherence to SL/WL ratio of 4 was 98% for Suture-TOOL and 69% for NDS. Suture-TOOL suturing was 30% faster.
The conclusion of the study is that Suture-TOOL is a promising device for clinical use. It is safe, easy, and fast resulting in a high-quality suture line with a short learning curve and a high functionality ranking.
Further studies and next steps
The device is undergoing clinical evaluation in a first in man study on patients selected for elective colorectal surgery. The study is estimated to be finalized in Q2 2023.
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- Gabriel Börner, Marcus Edelhamre, Peder Rogmark, Agneta Montgomery. Suture-TOOL: A suturing device for swift and standardized abdominal aponeurosis closure. Surgery in Practice and Science 11 (2022) 100137.
- Deerenberg E, Harlaar J, Steyerberg E et al (2015). Small bites versus large bites for closure of abdominal midline incisions (STITCH): a double-blind, multicentre, randomised controlled trial. Lancet 26(386):1254–1260 5.
- Gabriel Börner, Agneta Montgomery. Suture-TOOL: A Mechanical Needle Driver for Standardized Wound Closure World J Surg (2020) 44:95–99.
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