Ignite Creation Date:
2025-12-24 @ 7:02 PM
Ignite Modification Date:
2025-12-25 @ 4:36 PM
Study NCT ID:
NCT05695157
Status:
UNKNOWN
Last Update Posted:
2023-01-23
First Post:
2023-01-09
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Clinical Performance and Safety of Suture-TOOL
Sponsor:
Suturion AB
Organization:
Study Overview
Official Title:
Clinical Performance and Safety of Suture-TOOL for Abdominal Wound Closure in Men and Women Patients Undergoing Elective Open Abdominal Surgery
Status:
UNKNOWN
Status Verified Date:
2023-01
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: