NCT05695157

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
38

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 9, 2023

Completed
1 day until next milestone

Study Start

First participant enrolled

January 10, 2023

Completed
13 days until next milestone

First Posted

Study publicly available on registry

January 23, 2023

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 30, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 30, 2023

Completed
Last Updated

January 23, 2023

Status Verified

January 1, 2023

Enrollment Period

8 months

First QC Date

January 9, 2023

Last Update Submit

January 14, 2023

Conditions

LaparotomyIncisional HerniaWound InfectionClosure Technique

Outcome Measures

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.

    Measured during laparotomy closure.

Secondary Outcomes (5)

  • Stitch count

    Measured during laparotomy closure

  • Numbers of sutures used

    Counted during laparotomy closure

  • Incision closure time

    Measured during laparotomy closure

  • Surgeons´ comfort with device during closure

    After laparotomy closure

  • Surgeons´ satisfaction with final closure result

    After laparotomy closure

Other Outcomes (10)

  • Incision not following the midline (exposure of rectus muscle)

    During the whole study period of up to 8 months

  • Thickness of subcutaneous fat

    During the whole study period of up to 8 months

  • Glove punctures

    During the whole study period of up to 8 months

  • +7 more other outcomes

Study Arms (1)

Single arm

EXPERIMENTAL

Closure of the abdomen after laparotomy with Suture-TOOL.

Device: Suture-TOOL

Interventions

Suture-TOOLDEVICE

Suture device for fast and standardized closure of the abdominal fascia

Single arm

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Helsingborgs Hospital

Helsingborg, Skåne County, 25187, Sweden

RECRUITING

Related Publications (2)

  • 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.

    PMID: 31549201RESULT

  • 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.

    PMID: 39845163RESULT

MeSH Terms

Conditions

Incisional HerniaWound Infection

Condition Hierarchy (Ancestors)

HerniaPathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsPostoperative ComplicationsPathologic ProcessesInfections

Study Officials

  • Marcus Edelhamre, MD Phd

    Region Skåne

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Lena Toft, RN

CONTACT

+46(0)424061570lena.toft@skane.se

Marcus Edelhamre, MD Phd

CONTACT

+46(0)424061555marcus.edelhamre@skane.se

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Model Details: Single arm prospective interventional study
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 9, 2023

First Posted

January 23, 2023

Study Start

January 10, 2023

Primary Completion

August 30, 2023

Study Completion

August 30, 2023

Last Updated

January 23, 2023

Record last verified: 2023-01

Data Sharing

IPD Sharing
Will not share

Locations

SE(1)