Clinical Performance and Safety of Suture-TOOL

Suturion

Status: Enrolling

Conditions: Laparotomy; Incisional Hernia; Closure Technique; Wound Infection

Treatments: Device: Suture-TOOL

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT05695157

CRO-21-149

SUT 001 (Other Identifier)

CIV-22-09-040607 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 38 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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38 participants in 1 patient group

Single arm

Experimental group

Description:

Closure of the abdomen after laparotomy with Suture-TOOL.

Treatment:

Device: Suture-TOOL