CClinicalTrials.gg
Sign In
Status unknownNCT05695157Updated Jan 23, 2023

Clinical Performance and Safety of Suture-TOOL

An interventional study of Suture-TOOL in Laparotomy, Incisional Hernia and Wound Infection, sponsored by Suturion AB. Status unknown at 1 site in Sweden. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-01-23.

Sponsored by Suturion AB · Not applicable, Interventional, and Prevention

The sponsor has not verified this record recently (last verified Jan 2023), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
38
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

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.

02

Conditions studied

  • Laparotomy
  • Incisional Hernia
  • Wound Infection
  • Closure Technique
03

In context

Wound Infection

382 studies on the registry are indexed under Wound Infection; 40 are open to participants now.

This study's planned enrollment of 38 is below the median of 150 across 296 interventional studies indexed under Wound Infection.

Browse Wound Infection studies →

Lead sponsor

Suturion AB is the lead sponsor of 2 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
38 participants (estimated)

Study arms

  • Experimental
    Single arm

    Closure of the abdomen after laparotomy with Suture-TOOL.

    Device: Suture-TOOL

Interventions

  • DeviceSuture-TOOL

    Suture device for fast and standardized closure of the abdominal fascia

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Measured during laparotomy closure.

Secondary outcomes

  1. Stitch count

    Number of stitches used for laparotomy closure

    Time frame: Measured during laparotomy closure

  2. Numbers of sutures used

    Time frame: Counted during laparotomy closure

  3. Incision closure time

    Time (seconds) from first to last knot during laparotomy closure

    Time frame: Measured during laparotomy closure

  4. Surgeons´ comfort with device during closure

    VAS assessment

    Time frame: After laparotomy closure

  5. Surgeons´ satisfaction with final closure result

    VAS assessment

    Time frame: After laparotomy closure

Other outcomes

  1. Incision not following the midline (exposure of rectus muscle)

    Assessment of midline incision

    Time frame: During the whole study period of up to 8 months

  2. Thickness of subcutaneous fat

    Measurement of subcutaneous fat (millimeter)

    Time frame: During the whole study period of up to 8 months

  3. Glove punctures

    Standardized assessment of puncture holes

    Time frame: During the whole study period of up to 8 months

  4. Re-operation(s) number

    Chart review

    Time frame: 45 days after surgery

  5. Reasons for unscheduled post-surgery visits

    Chart review

    Time frame: 45 days after surgery

  6. 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.

    Time frame: During the whole study period of up to 8 months

  7. Type of adverse device effects

    Identification of adverse device effects

    Time frame: During the whole study period of up to 8 months

  8. Type of device deficiencies

    Identification of device deficiences

    Time frame: During the whole study period of up to 8 months

  9. Reasons for device replacement during surgery

    Identification during study period

    Time frame: During the whole study period of up to 8 months

  10. Patients with wound infections

    Wound infection postoperatively

    Time frame: 45 days after surgery

07

Study locations

1 of 1 sites recruiting
08

References and documents

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. PubMed 31549201 ↗
  • 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

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 23, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05695157
Lead sponsor
Suturion AB
Collaborators
Helsingborgs Hospital, Cross Research S.A.
Responsible party
Sponsor
First posted
Jan 23, 2023
Start date
Jan 10, 2023
Primary completion
Aug 30, 2023 (estimated)
Completion
Aug 30, 2023 (estimated)
Last update
Jan 23, 2023

Study contacts

Lena Toft, RN
Contact
lena.toft@skane.se
+46(0)424061570
Marcus Edelhamre, MD Phd
Contact
marcus.edelhamre@skane.se
+46(0)424061555
Marcus Edelhamre, MD Phd
principal investigator · Region Skåne

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jan 2023. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Wound Infection→

Other studies from this sponsor

Suturion AB

Start the discussion