Clinical Performance and Safety of Suture-TOOL

Clinical Performance and Safety of Suture-TOOL for Abdominal Wound Closure in Men and Women Patients Undergoing Elective Open Abdominal Surgery

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.

Study Overview

• Status: Recruiting
• Conditions: Wound Infection; Incisional Hernia; Laparotomy; Closure Technique
• Intervention / Treatment: Device: Suture-TOOL

• Study Type: Interventional
• Enrollment (Anticipated): 38
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Lena Toft, RN; Phone Number: +46(0)424061570; Email: lena.toft@skane.se
• Study Contact Backup: Name: Marcus Edelhamre, MD Phd; Phone Number: +46(0)424061555; Email: marcus.edelhamre@skane.se

Study Locations

• Sweden
  • Scania
    • Helsingborg, Scania, Sweden, 25187
      • Recruiting
      • Helsingborgs Hospital
      • Contact: Marcus Edelhamre, MD Phd; Phone Number: +46(0)424061555; Email: marcus.edelhamre@skane.se
      • Contact: Gabriel Börner, MD; Phone Number: +46(0)424061276; Email: gabriel.borner@med.lu.se

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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.

Secondary Outcome Measures

Outcome Measure	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
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

Other Outcome Measures

Outcome Measure	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)	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

Collaborators and Investigators

• Sponsor: Suturion AB
• Collaborators: Cross Research S.A.; Helsingborgs Hospital
• Investigators: Principal Investigator: Marcus Edelhamre, MD Phd, Region Skane

Publications and helpful links

General Publications

• 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.
• 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

Study record dates

Study Major Dates

• Study Start (Actual): January 10, 2023
• Primary Completion (Anticipated): August 30, 2023
• Study Completion (Anticipated): August 30, 2023

Study Registration Dates

• First Submitted: January 9, 2023
• First Submitted That Met QC Criteria: January 14, 2023
• First Posted (Actual): January 23, 2023

Study Record Updates

• Last Update Posted (Actual): January 23, 2023
• Last Update Submitted That Met QC Criteria: January 14, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Postoperative Complications; Pathological Conditions, Anatomical; Hernia; Wound Infection; Incisional Hernia
• Other Study ID Numbers: CRO-21-149; CIV-22-09-040607 (Other Identifier: Swedish Medical Products Agency); SUT 001 (Other Identifier: Suturion AB)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No