Back to resultsUse of Stratafix Symmetric™ to Prevent Incisional Hernia in Gastrointestinal and Abdominal Surgery (STRATA-G)
Primary Purpose
C.Surgical Procedure; Disruption of Wound, Suture
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Stratafix suture
Standard of care suture
Sponsored by
About this trial
This is an interventional treatment trial for C.Surgical Procedure; Disruption of Wound, Suture
Eligibility Criteria
Inclusion Criteria: Participant is a male or female 18 years of age or older. Participant is a current patient at West Michigan Cancer Center. Participant is undergoing liver, pancreas or biliary or gastrointestinal surgery of a combination of the above, or other major oncological surgery. Participant is willing and able to provide written informed consent before surgery. Exclusion Criteria: Participant has hemodynamic instability at the conclusion of the surgery. (These subjects will be deemed disqualified). Participant has history of previous VIH. Participant has a mental condition rendering the subject incapable of understanding the nature, scope and consequences of the study.
Sites / Locations
- West Michigan Cancer CenterRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Stratafix Group
Control Group
Arm Description
Stratafix
Standard of care
Outcomes
Primary Outcome Measures
Number of participants who develop ventral incisional hernia
Infection, seroma, surgical site infection, evisceration, mesh rejection, systemic complications
Secondary Outcome Measures
Safety of stratafix sutures compared to standard of care wound closure
Assessing adverse events related to the suture
Change in quality of life
Carolinas Comfort Scale (CCS) questionnaire (a validated, disease-specific, quality of life (QOL) questionnaire developed for patients undergoing hernia repair)
Change in quality of life
Functional Assessment of Cancer Therapy-Hepatobiliary (FACT-Hep) questionnaire (a 45-item questionnaire assesses health-related quality of life in patients with liver, bile duct and pancreatic cancers
Post operative pain
Visual analog score
Full Information
NCT ID
NCT06063577
First Posted
September 2, 2023
Last Updated
October 6, 2023
Sponsor
West Michigan Cancer Center
Collaborators
Ethicon, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT06063577
Brief Title
Use of Stratafix Symmetric™ to Prevent Incisional Hernia in Gastrointestinal and Abdominal Surgery
Acronym
STRATA-G
Official Title
A Randomized Controlled Trial Evaluating the Use of Stratafix Symmetric™ to Prevent Incisional Hernia in Gastrointestinal and Abdominal Surgery
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 2023 (Anticipated)
Primary Completion Date
October 2026 (Anticipated)
Study Completion Date
October 2026 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
West Michigan Cancer Center
Collaborators
Ethicon, Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No
5. Study Description
Brief Summary
Comparing the use of Stratafix Symmetric™ sutures to standard laparotomy closure sutures.
Detailed Description
Determine whether the use of Stratafix Symmetric™ sutures reduces the development of Ventral Incisional Hernia (VIH) in patients undergoing complex GI surgery compared to standard laparotomy closure. Determine the safety of Stratafix Symmetric™ sutures compared to standard laparotomy closure sutures and the impact on quality of life and level of pain.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
C.Surgical Procedure; Disruption of Wound, Suture
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Masking Description
Patients will be blinded after the assignment.
Allocation
Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Stratafix Group
Arm Type
Active Comparator
Arm Description
Stratafix
Arm Title
Control Group
Arm Type
Placebo Comparator
Arm Description
Standard of care
Intervention Type
Device
Intervention Name(s)
Stratafix suture
Intervention Description
Stratafix symmetric suture
Intervention Type
Device
Intervention Name(s)
Standard of care suture
Intervention Description
Standard of care suture
Primary Outcome Measure Information:
Title
Number of participants who develop ventral incisional hernia
Description
Infection, seroma, surgical site infection, evisceration, mesh rejection, systemic complications
Time Frame
From enrollment to end of study participation at 12 months
Secondary Outcome Measure Information:
Title
Safety of stratafix sutures compared to standard of care wound closure
Description
Assessing adverse events related to the suture
Time Frame
From enrollment to end of study participation at 12 months
Title
Change in quality of life
Description
Carolinas Comfort Scale (CCS) questionnaire (a validated, disease-specific, quality of life (QOL) questionnaire developed for patients undergoing hernia repair)
Time Frame
"Month 1," "Month 3," "Month 6," "Month 12"
Title
Change in quality of life
Description
Functional Assessment of Cancer Therapy-Hepatobiliary (FACT-Hep) questionnaire (a 45-item questionnaire assesses health-related quality of life in patients with liver, bile duct and pancreatic cancers
Time Frame
"Day 1," "Month 1," "Month 3," "Month 6," "Month 12"
Title
Post operative pain
Description
Visual analog score
Time Frame
From enrollment to end of study participation at 12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Participant is a male or female 18 years of age or older.
Participant is a current patient at West Michigan Cancer Center.
Participant is undergoing liver, pancreas or biliary or gastrointestinal surgery of a combination of the above, or other major oncological surgery.
Participant is willing and able to provide written informed consent before surgery.
Exclusion Criteria:
Participant has hemodynamic instability at the conclusion of the surgery. (These subjects will be deemed disqualified).
Participant has history of previous VIH.
Participant has a mental condition rendering the subject incapable of understanding the nature, scope and consequences of the study.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Wendi Mitchell
Phone
269-373-7443
Email
research@wmcc.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gitonga Munene
Organizational Affiliation
West Michigan Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
West Michigan Cancer Center
City
Kalamazoo
State/Province
Michigan
ZIP/Postal Code
49007
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Wendi Mitchell
Phone
269-373-7443
Email
wmitchell@wmcc.org
First Name & Middle Initial & Last Name & Degree
Kathleen Allen
Phone
269-373-7452
Email
kallen@wmcc.org
First Name & Middle Initial & Last Name & Degree
Gitonga Munene, MD
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Use of Stratafix Symmetric™ to Prevent Incisional Hernia in Gastrointestinal and Abdominal Surgery
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