NCT05695157

Clinical Performance and Safety of Suture-TOOL

Clinical Performance and Safety of Suture-TOOL for Abdominal Wound Closure in Men and Women Patients Undergoing Elective Open Abdominal Surgery

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 38 (estimated)
• Sponsor: Suturion AB · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The goal of this single arm intervention study is to investigate the safety and performance of a suturing device for closure of the midline incision after open abdominal surgery. The study population consists of 38 patients selected for open abdominal procedures for malignant and benign colorectal disease. The main question it aims to answer is: • If the device facilitates a Suture-Length to Wound-Length (SL/WL) ratio of 4:1 Participants laparotomy wound will be closed with the device at the end of the operation and closure related data as closure time and SL/WL ratio will be calculated. The wound will be assessed for infection during the postoperative stay and the chart will be reviewed for wound dehiscence and wound infection.

Conditions

• Laparotomy
• Incisional Hernia
• Wound Infection
• Closure Technique

Interventions

Type	Name	Description
DEVICE	Suture-TOOL	Suture device for fast and standardized closure of the abdominal fascia

Timeline

• Start date: 2023-01-10
• Primary completion: 2023-08-30
• Completion: 2023-08-30
• First posted: 2023-01-23
• Last updated: 2023-01-23

Locations

1 site across 1 country: Sweden