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| ID | Type | Description | Link |
|---|---|---|---|
| CIV-22-09-040607 | Other Identifier | Swedish Medical Products Agency | |
| SUT 001 | Other Identifier | Suturion AB |
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| Name | Class |
|---|---|
| Helsingborgs Hospital | OTHER |
| Cross Research S.A. | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single arm | Experimental | Closure of the abdomen after laparotomy with Suture-TOOL. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Suture-TOOL | Device | Suture device for fast and standardized closure of the abdominal fascia |
|
| 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. |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Incision not following the midline (exposure of rectus muscle) | Assessment of midline incision | During the whole study period of up to 8 months |
| Thickness of subcutaneous fat | Measurement of subcutaneous fat (millimeter) |
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:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Lena Toft, RN | Contact | +46(0)424061570 | lena.toft@skane.se | |
| Marcus Edelhamre, MD Phd | Contact | +46(0)424061555 | marcus.edelhamre@skane.se |
| Name | Affiliation | Role |
|---|---|---|
| Marcus Edelhamre, MD Phd | Region Skane | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Helsingborgs Hospital | Recruiting | Helsingborg | Skåne County | 25187 | Sweden |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31549201 | Result | 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. | |
| 39845163 | Result | Borner G, Edelhamre M, Rogmark P, Montgomery A. Suture-TOOL: A suturing device for swift and standardized abdominal aponeurosis closure. Surg Pract Sci. 2022 Oct 5;11:100137. doi: 10.1016/j.sipas.2022.100137. eCollection 2022 Dec. |
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| ID | Term |
|---|---|
| D000069290 | Incisional Hernia |
| D014946 | Wound Infection |
| ID | Term |
|---|---|
| D006547 | Hernia |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D011183 | Postoperative Complications |
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Single arm prospective interventional study
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| 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 |
| During the whole study period of up to 8 months |
| Glove punctures | Standardized assessment of puncture holes | During the whole study period of up to 8 months |
| Re-operation(s) number | Chart review | 45 days after surgery |
| Reasons for unscheduled post-surgery visits | Chart review | 45 days after surgery |
| Type of adverse effects | 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. | During the whole study period of up to 8 months |
| Type of adverse device effects | Identification of adverse device effects | During the whole study period of up to 8 months |
| Type of device deficiencies | Identification of device deficiences | During the whole study period of up to 8 months |
| Reasons for device replacement during surgery | Identification during study period | During the whole study period of up to 8 months |
| Patients with wound infections | Wound infection postoperatively | 45 days after surgery |
| D010335 | Pathologic Processes |
| D007239 | Infections |