STRATA-G: Use of Stratafix Symmetric™ to Prevent Incisional Hernia in Gastrointestinal and Abdominal Surgery

Sponsor

West Michigan Cancer Center (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT06063577

Collaborator

Ethicon, Inc. (Industry)

100

Enrollment

Arms

Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

Comparing the use of Stratafix Symmetric™ sutures to standard laparotomy closure sutures.

Condition or Disease	Intervention/Treatment	Phase
C.Surgical Procedure; Disruption of Wound, Suture	Device: Stratafix suture Device: Standard of care suture	N/A

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

100 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Participant)

Masking Description:

Patients will be blinded after the assignment.

Primary Purpose:

Treatment

Official Title:

A Randomized Controlled Trial Evaluating the Use of Stratafix Symmetric™ to Prevent Incisional Hernia in Gastrointestinal and Abdominal Surgery

Anticipated Study Start Date :

Sep 1, 2023

Anticipated Primary Completion Date :

Sep 1, 2026

Anticipated Study Completion Date :

Sep 1, 2026

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Stratafix Group Stratafix	Device: Stratafix suture Stratafix symmetric suture
Placebo Comparator: Control Group Standard of care	Device: Standard of care suture Standard of care suture

Arm

Intervention/Treatment

Active Comparator: Stratafix Group

Stratafix

Device: Stratafix suture

Stratafix symmetric suture

Placebo Comparator: Control Group

Standard of care

Device: Standard of care suture

Standard of care suture

Outcome Measures

Primary Outcome Measures

Number of participants who develop ventral incisional hernia [From enrollment to end of study participation at 12 months]
Infection, seroma, surgical site infection, evisceration, mesh rejection, systemic complications

Secondary Outcome Measures

Safety of stratafix sutures compared to standard of care wound closure [From enrollment to end of study participation at 12 months]
Assessing adverse events related to the suture
Change in quality of life ["Month 1," "Month 3," "Month 6," "Month 12"]
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 ["Day 1," "Month 1," "Month 3," "Month 6," "Month 12"]
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 [From enrollment to end of study participation at 12 months]
Visual analog score

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

West Michigan Cancer Center
Ethicon, Inc.

Investigators

Principal Investigator: Gitonga Munene, West Michigan Cancer Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Gitonga Munene, Principal Investigator, West Michigan Cancer Center

ClinicalTrials.gov Identifier:

NCT06063577

Other Study ID Numbers:

001-2023

First Posted:

Oct 2, 2023

Last Update Posted:

Oct 2, 2023

Last Verified:

Sep 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Yes

Product Manufactured in and Exported from the U.S.:

Yes

Additional relevant MeSH terms:

Incisional Hernia

Study Results

No Results Posted as of Oct 2, 2023