Clinical Performance and Safety of Suture-TOOL

Study Overview
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Brief Summary
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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.

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

Conditions
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Laparotomy, Incisional Hernia, Wound Infection, Closure Technique

Intervention / Treatment
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* Device: Suture-TOOL


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Informed consent: signed written informed consent before inclusion in the investigation Sex, age: male and female patients, ≥ 18 years old Surgery: elective open abdominal surgery for benign or malignant colorectal disease through midline incision. Anticipated incision length ≥ 12 cm Body Mass Index (BMI): 18 - 40 kg/m2 inclusive 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: Abdominal Surgery: previous abdominal surgery involving the midline 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 Pre-operative findings: any pre-operative findings identified by the surgeon/Investigator that may preclude the conduct of the investigation procedures Allergy: history of anaphylaxis to drugs or allergic reactions in general, which the Investigator considers could affect the outcome of the investigation 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 Life expectancy: life expectancy less than 1 year 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 Pregnancy and lactation: positive pregnancy test at screening (if applicable); pregnant or breastfeeding women 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Intervention Model: Single Group Assignment
Interventional Model Description: Single arm prospective interventional study
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Single arm<br>Closure of the abdomen after laparotomy with Suture-TOOL. | Device: Suture-TOOL<br>* Suture device for fast and standardized closure of the abdominal fascia<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of patients with Suture length/Wound length (SL/WL) ratio ≥ 4 | SL/WL-ratio of patients laparotomy closures will be calculated by measuring (centimeter) and dividing the length of used suture with the length of the laparotomy wound. | Measured during laparotomy closure. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Stitch count | Number of stitches used for laparotomy closure | Measured during laparotomy closure | 
| Numbers of sutures used |  | Counted during laparotomy closure | 
| Incision closure time | Time (seconds) from first to last knot during laparotomy closure | Measured during laparotomy closure | 
| Surgeons´ comfort with device during closure | VAS assessment | After laparotomy closure | 
| Surgeons´ satisfaction with final closure result | VAS assessment | After laparotomy closure |