Clinical Performance and Safety of Suture-TOOL

Launched by SUTURION AB · Jan 14, 2023

Keywords

ClinConnect Summary

This clinical trial is studying a new suturing device called Suture-TOOL, which is designed to help close the midline incision made during open abdominal surgery. The main goal is to see if this device can improve the way wounds are closed, specifically looking for a good balance between the length of the stitches and the length of the wound. The trial will involve 38 patients who are having surgery for conditions related to their intestines, whether benign (non-cancerous) or malignant (cancerous).

To participate in this study, patients must be at least 18 years old and able to provide informed consent, meaning they understand what the study is about and any potential risks. They should be undergoing elective open abdominal surgery with a certain size incision. However, individuals with previous midline surgery, certain health conditions, or allergies might not qualify. During the trial, participants can expect their wounds to be closed using the Suture-TOOL, and their recovery will be monitored for any signs of infection or complications. Overall, this study aims to evaluate the safety and effectiveness of this new suturing technique to improve postoperative outcomes.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Informed consent: signed written informed consent before inclusion in the investigation
• • 2. Sex, age: male and female patients, ≥ 18 years old
• • 3. Surgery: elective open abdominal surgery for benign or malignant colorectal disease through midline incision.
• • Anticipated incision length ≥ 12 cm
• • 4. Body Mass Index (BMI): 18 - 40 kg/m2 inclusive
• • 5. Full comprehension: ability to comprehend the full nature and purpose of the investigation, including possible risks and side effects; ability to co-operate with the Investigator and to comply with the requirements of the entire investigation.
• Exclusion Criteria:
• • 1. Abdominal Surgery: previous abdominal surgery involving the midline
• • 2. Physical findings: clinically significant abnormal physical findings which could interfere with the objectives of the investigation according to the Investigator's opinion; existing midline hernia, cutaneous infection, fistula, psoriasis of abdominal skin; morbidly obese patients
• • 3. Pre-operative findings: any pre-operative findings identified by the surgeon/Investigator that may preclude the conduct of the investigation procedures
• • 4. Allergy: history of anaphylaxis to drugs or allergic reactions in general, which the Investigator considers could affect the outcome of the investigation
• • 5. Diseases: known or identified at surgery disseminated cancer disease; collagen diseases and immune deficiency disorders, according to the Investigator's opinion. Significant history of renal, hepatic, gastrointestinal, cardiovascular, respiratory, skin, haematological, endocrine or neurological diseases that according to the Investigator's opinion may interfere with the aim of the investigation
• • 6. Life expectancy: life expectancy less than 1 year
• • 7. Medications: any medication that could interfere with the investigation procedures or investigation outcome, according to the Investigator's opinion. Hormonal contraceptives for women are allowed
• • 8. Pregnancy and lactation: positive pregnancy test at screening (if applicable); pregnant or breastfeeding women
• • 9. Vulnerable subjects: Individuals unable to fully understand all aspects of the investigation that are relevant to the decision to participate, or who could be manipulated or unduly influenced because of a compromised position, expectation of benefits or fear of retaliatory response (ISO 14155:2020 §3.55) will be excluded