Clinical Performance and Safety of Suture-TOOL

Last updated: January 14, 2023
Sponsor: Suturion AB
Overall Status: Active - Recruiting

Phase

N/A

Condition

Hernia

Treatment

N/A

Clinical Study ID

NCT05695157
CRO-21-149
CIV-22-09-040607
SUT 001
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Informed consent: signed written informed consent before inclusion in theinvestigation
  2. Sex, age: male and female patients, ≥ 18 years old
  3. Surgery: elective open abdominal surgery for benign or malignant colorectal diseasethrough 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 theinvestigation, including possible risks and side effects; ability to co-operate withthe Investigator and to comply with the requirements of the entire investigation.

Exclusion

Exclusion Criteria:

  1. Abdominal Surgery: previous abdominal surgery involving the midline
  2. Physical findings: clinically significant abnormal physical findings which couldinterfere with the objectives of the investigation according to the Investigator'sopinion; existing midline hernia, cutaneous infection, fistula, psoriasis of abdominalskin; morbidly obese patients
  3. Pre-operative findings: any pre-operative findings identified by thesurgeon/Investigator that may preclude the conduct of the investigation procedures
  4. Allergy: history of anaphylaxis to drugs or allergic reactions in general, which theInvestigator considers could affect the outcome of the investigation
  5. Diseases: known or identified at surgery disseminated cancer disease; collagendiseases 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 theInvestigator'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 orinvestigation outcome, according to the Investigator's opinion. Hormonalcontraceptives 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 theinvestigation that are relevant to the decision to participate, or who could bemanipulated or unduly influenced because of a compromised position, expectation ofbenefits or fear of retaliatory response (ISO 14155:2020 §3.55) will be excluded

Study Design

Total Participants: 38
Study Start date:
January 10, 2023
Estimated Completion Date:
August 30, 2023

Connect with a study center

  • Helsingborgs Hospital

    Helsingborg, Scania 25187
    Sweden

    Active - Recruiting

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