Use of Stratafix Symmetric™ to Prevent Incisional Hernia in Gastrointestinal and Abdominal Surgery

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-12-01

Study Completion Date

2026-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Study to Compare Suture Material in Closure of Uterine Incision in Cesarian Section

NCT02517710

Hysterotomy Closure

COMPLETED NA

Clinical Trial on the Use of Stratafix Symmetric vs. Resorbable Monofilament for Closure of Large Median Laparotomy in Oncological Patients

NCT07218679

Incisional Hernia After Midline Laparotomy

ACTIVE_NOT_RECRUITING NA

A Study to Evaluate Two Different Surgical Methods for Treatment for Abdominal Wall Diastasis

NCT01586741

Abdominal Hernias and Other Abdominal Wall Conditions Post-operative Pain Recurrence

COMPLETED NA

Closing Uterine Incision During C-section Using Barbed Suture (Stratafix) or Vicryl Suture.

NCT03159871

Cesarean Section

COMPLETED NA

Antiseptic-Coated Sutures and Pancreatic Fistula Risk After Pancreatoduodenectomy

NCT07318493

Pancreatoduodenectomy Whipple Procedure

RECRUITING NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

C.Surgical Procedure; Disruption of Wound, Suture

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Patients will be blinded after the assignment.

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Stratafix Group

Stratafix

Group Type ACTIVE_COMPARATOR

Stratafix suture

Intervention Type DEVICE

Stratafix symmetric suture

Control Group

Standard of care

Group Type PLACEBO_COMPARATOR

Standard of care suture

Intervention Type DEVICE

Standard of care suture

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Stratafix suture

Stratafix symmetric suture

Intervention Type DEVICE

Standard of care suture

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

1. Participant is a male or female 18 years of age or older.
2. Participant is a current patient at West Michigan Cancer Center.
3. Participant is undergoing liver, pancreas or biliary or gastrointestinal surgery of a combination of the above, or other major oncological surgery.
4. Participant is willing and able to provide written informed consent before surgery.

Exclusion Criteria

1. Participant has hemodynamic instability at the conclusion of the surgery. (These subjects will be deemed disqualified).
2. Participant has history of previous VIH.
3. Participant has a mental condition rendering the subject incapable of understanding the nature, scope and consequences of the study.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No