Clinical trial NCT05695157: Clinical Performance and Safety of Suture-TOOL
Official title: Clinical Performance and Safety of Suture-TOOL for Abdominal Wound Closure in Men and Women Patients Undergoing Elective Open Abdominal Surgery
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Laparotomy
Incisional Hernia
Wound Infection
Closure Technique
Lead sponsor: Suturion AB
Sponsor class: INDUSTRY
Collaborators: name: Helsingborgs Hospital
name: Cross Research S.A.
First posted: 2023-01-23
Enrollment: 38
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Single arm prospective interventional study
Primary purpose: PREVENTION

Brief 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 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

Primary outcomes:
measure: Proportion of patients with Suture length/Wound length (SL/WL) ratio ≥ 4
timeFrame: Measured during laparotomy closure.
Secondary outcomes:
measure: Stitch count
timeFrame: Measured during laparotomy closure
measure: Numbers of sutures used
timeFrame: Counted during laparotomy closure
measure: Incision closure time
timeFrame: Measured during laparotomy closure
measure: Surgeons´ comfort with device during closure
timeFrame: After laparotomy closure
measure: Surgeons´ satisfaction with final closure result
timeFrame: After laparotomy closure
Other outcomes:
measure: Incision not following the midline (exposure of rectus muscle)
timeFrame: During the whole study period of up to 8 months
measure: Thickness of subcutaneous fat
timeFrame: During the whole study period of up to 8 months
measure: Glove punctures
timeFrame: During the whole study period of up to 8 months
measure: Re-operation(s) number
timeFrame: 45 days after surgery
measure: Reasons for unscheduled post-surgery visits
timeFrame: 45 days after surgery
measure: Type of adverse effects
timeFrame: During the whole study period of up to 8 months
measure: Type of adverse device effects
timeFrame: During the whole study period of up to 8 months
measure: Type of device deficiencies
timeFrame: During the whole study period of up to 8 months
measure: Reasons for device replacement during surgery
timeFrame: During the whole study period of up to 8 months
measure: Patients with wound infections
timeFrame: 45 days after surgery
Locations:
city: Helsingborg
country: Sweden
facility: Helsingborgs Hospital
state: Scania
Study officials:
affiliation: Region Skåne
name: Marcus Edelhamre, MD Phd
role: PRINCIPAL_INVESTIGATOR
References:
citation: Borner G, Montgomery A. Suture-Tool: A Mechanical Needle Driver for Standardized Wound Closure. World J Surg. 2020 Jan;44(1):95-99. doi: 10.1007/s00268-019-05179-5.
citation: Borner G, Edelhamre M, Rogmark P, Montgomery A. Suture-TOOL: A suturing device for swift and standardized abdominal aponeurosis closure. Surgery in Practice and Science 2022 11. 100137/doi.org/10.1016