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Clinical Performance and Safety of Suture-TOOL

NCT05695157 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 38

Last updated 2023-01-23

No results posted yet for this 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.

Conditions

  • Laparotomy
  • Incisional Hernia
  • Wound Infection
  • Closure Technique

Interventions

DEVICE

Suture-TOOL

Suture device for fast and standardized closure of the abdominal fascia

Sponsors & Collaborators

  • Helsingborgs Hospital

    collaborator OTHER

  • Cross Research S.A.

    collaborator INDUSTRY

  • Suturion AB

    lead INDUSTRY

Principal Investigators

  • Marcus Edelhamre, MD Phd · Region Skåne

Study Design

Allocation
NA
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-01-10
Primary Completion
2023-08-30
Completion
2023-08-30

Countries

  • Sweden

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05695157 on ClinicalTrials.gov