Clinical Performance and Safety of Suture-TOOL
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Single arm Closure of the abdomen after laparotomy with Suture-TOOL. |
Device: Suture-TOOL
Suture device for fast and standardized closure of the abdominal fascia
|
Outcome Measures
Primary Outcome Measures
- Proportion of patients with Suture length/Wound length (SL/WL) ratio ≥ 4 [Measured during laparotomy closure.]
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.
Secondary Outcome Measures
- Stitch count [Measured during laparotomy closure]
Number of stitches used for laparotomy closure
- Numbers of sutures used [Counted during laparotomy closure]
- Incision closure time [Measured during laparotomy closure]
Time (seconds) from first to last knot during laparotomy closure
- Surgeons´ comfort with device during closure [After laparotomy closure]
VAS assessment
- Surgeons´ satisfaction with final closure result [After laparotomy closure]
VAS assessment
Other Outcome Measures
- Incision not following the midline (exposure of rectus muscle) [During the whole study period of up to 8 months]
Assessment of midline incision
- Thickness of subcutaneous fat [During the whole study period of up to 8 months]
Measurement of subcutaneous fat (millimeter)
- Glove punctures [During the whole study period of up to 8 months]
Standardized assessment of puncture holes
- Re-operation(s) number [45 days after surgery]
Chart review
- Reasons for unscheduled post-surgery visits [45 days after surgery]
Chart review
- Type of adverse effects [During the whole study period of up to 8 months]
All adverse effects derived by spontaneous, unsolicited reports of the subjects or users/handlers, by observation and by routine open questioning will be collected and reported.
- Type of adverse device effects [During the whole study period of up to 8 months]
Identification of adverse device effects
- Type of device deficiencies [During the whole study period of up to 8 months]
Identification of device deficiences
- Reasons for device replacement during surgery [During the whole study period of up to 8 months]
Identification during study period
- Patients with wound infections [45 days after surgery]
Wound infection postoperatively
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Informed consent: signed written informed consent before inclusion in the investigation
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Sex, age: male and female patients, ≥ 18 years old
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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
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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:
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Abdominal Surgery: previous abdominal surgery involving the midline
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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
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Pre-operative findings: any pre-operative findings identified by the surgeon/Investigator that may preclude the conduct of the investigation procedures
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Allergy: history of anaphylaxis to drugs or allergic reactions in general, which the Investigator considers could affect the outcome of the investigation
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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
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Life expectancy: life expectancy less than 1 year
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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
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Pregnancy and lactation: positive pregnancy test at screening (if applicable); pregnant or breastfeeding women
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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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Helsingborgs Hospital | Helsingborg | Scania | Sweden | 25187 |
Sponsors and Collaborators
- Suturion AB
- Helsingborgs Hospital
- Cross Research S.A.
Investigators
- Principal Investigator: Marcus Edelhamre, MD Phd, Region Skåne
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- CRO-21-149
- CIV-22-09-040607
- SUT 001