LaparotomyNCT05695157
Clinical Performance and Safety of Suture-TOOL
A study testing Suture-TOOL in people with Laparotomy and Incisional Hernia, run by Suturion AB at 1 site in Sweden.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Laparotomy, Incisional Hernia, Wound Infection
- What is being tested?
- Suture-TOOL
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 1 siteSweden
- Study dates
- 10 Jan 2023to 30 Aug 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Abdominal Surgery: previous abdominal surgery involving the midline
- 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
- Pre-operative findings: any pre-operative findings identified by the surgeon/Investigator that may preclude the conduct of the investigation procedures
- Allergy: history of anaphylaxis to drugs or allergic reactions in general, which the Investigator considers could affect the outcome of the investigation
- 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
- 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
- Pregnancy and lactation: positive pregnancy test at screening (if applicable); pregnant or breastfeeding women
- 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
Trial locations and contacts
1 site in 1 country.
Sweden1 site, 1 recruiting
- Recruiting
Helsingborgs Hospital
Helsingborg, Skåne County, 25187
Marcus Edelhamre, MD Phd, +46(0)424061555, marcus.edelhamre@skane.se
Gabriel Börner, MD, +46(0)424061276, gabriel.borner@med.lu.se
About this study
Official title: 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:
Read more
- 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.
- Conditions
- Laparotomy, Incisional Hernia, Wound Infection, Closure Technique
- Being tested
- Suture-TOOL
- Medical subject headings
- Incisional Hernia, Wound Infection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Suture-TOOLDevice
Suture device for fast and standardized closure of the abdominal fascia
| Study group | Role | What they receive |
|---|---|---|
| Single arm | Experimental | Closure of the abdomen after laparotomy with Suture-TOOL. Receives: Device: Suture-TOOL |
What is being measured
The primary outcome is the main question the study is designed to answer.
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: Measured during laparotomy closure.
Secondary outcomes (5)
Stitch count
Number of stitches used for laparotomy closure
Measured: Measured during laparotomy closure
Numbers of sutures used
Measured: Counted during laparotomy closure
Incision closure time
Time (seconds) from first to last knot during laparotomy closure
Measured: Measured during laparotomy closure
Surgeons´ comfort with device during closure
VAS assessment
Measured: After laparotomy closure
Surgeons´ satisfaction with final closure result
VAS assessment
Measured: After laparotomy closure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2023
- Study start10 Jan 2023
- Primary completion30 Aug 2023 (estimated)
- Study completion30 Aug 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for LaparotomyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Single arm prospective interventional study
- Masking
- None (open label)
- Enrolment
- 38 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Suturion AB
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Helsingborgs Hospital, Cross Research S.A.
- Responsible party
- Sponsor
- Investigators
- Marcus Edelhamre, MD Phd, Principal investigator, Region Skane
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05695157
- Sponsor's protocol ID
- CRO-21-149
- Other IDs
- CIV-22-09-040607, SUT 001
- Status last verified
- Jan 2023
- First submitted
- 9 Jan 2023
- Last updated
- 23 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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 31549201Borner 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.
PubMed 39845163
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Performance and Safety of Suture-TOOL for Abdominal Wound Closure in Men and Women Patients Undergoing Elective Open Abdominal Surgery
- ClinicalTrials.gov ID
- NCT05695157
- Acronym / sponsor ID
- CRO-21-149
- Conditions
- Laparotomy, Incisional Hernia, Wound Infection, Closure Technique
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 38 participants (estimated)
- Lead sponsor
- Suturion ABIndustry (pharma, biotech, devices)
- Collaborators
- Helsingborgs Hospital, Cross Research S.A.
- Study start
- 10 Jan 2023 (actual)
- Primary completion
- 30 Aug 2023 (estimated)
- Study completion
- 30 Aug 2023 (estimated)
- First posted
- 23 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single arm prospective interventional study
| Arm | Type | Receives |
|---|---|---|
| Single arm | Experimental | Device: Suture-TOOLClosure of the abdomen after laparotomy with Suture-TOOL. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (9 listed)
- Abdominal Surgery: previous abdominal surgery involving the midline
- 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
- Pre-operative findings: any pre-operative findings identified by the surgeon/Investigator that may preclude the conduct of the investigation procedures
- Allergy: history of anaphylaxis to drugs or allergic reactions in general, which the Investigator considers could affect the outcome of the investigation
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Suture-TOOLSuture device for fast and standardized closure of the abdominal fascia | Device | Single arm |
Primary outcome
Proportion of patients with Suture length/Wound length (SL/WL) ratio ≥ 4
Time frame: 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.
5 secondary outcomes
Stitch count
Time frame: Measured during laparotomy closure
Numbers of sutures used
Time frame: Counted during laparotomy closure
Incision closure time
Time frame: Measured during laparotomy closure
Surgeons´ comfort with device during closure
Time frame: After laparotomy closure
Surgeons´ satisfaction with final closure result
Time frame: After laparotomy closure
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2023.
- Results publication: PubMed 31549201Borner 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.
- Results publication: PubMed 39845163Borner 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marcus Edelhamre, MD Phd principal investigator
Region Skane
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Suture-TOOL in people with Laparotomy and Incisional Hernia, run by Suturion AB at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Lena Toft, RN (+46(0)424061570, lena.toft@skane.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of patients with Suture length/Wound length (SL/WL) ratio ≥ 4 (time frame: Measured during laparotomy closure.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05695157, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jan 2023.