C.Surgical Procedure; Disruption of Wound, SutureSTRATA-GNCT06063577

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

A study testing Stratafix suture in people with C.Surgical Procedure; Disruption of Wound, Suture, run by West Michigan Cancer Center at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts

Official record

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Trial summary

Comparing the use of Stratafix Symmetric™ sutures to standard laparotomy closure sutures. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: C.Surgical Procedure; Disruption of Wound, Suture
What is being tested?: Stratafix suture
Type of treatment: Medical device
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 100 participants
Where: 1 siteUnited States
Study dates: 1 Dec 2023to Dec 2026
Phase: Interventional
Are there results?: Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

Who cannot join

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.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Wendi Mitchell contact

269-373-7443

research@wmcc.org

United States1 site, 1 recruiting

West Michigan Cancer Center
Kalamazoo, Michigan, 49007
Wendi Mitchell, 269-373-7443, wmitchell@wmcc.org
Kathleen Allen, 269-373-7452, kallen@wmcc.org
Recruiting

Other trials in United States

About this study

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

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

Read the 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.

Conditions: C.Surgical Procedure; Disruption of Wound, Suture
Being tested: Stratafix suture, Standard of care suture

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Stratafix sutureDevice
Stratafix symmetric suture
Standard of care sutureDevice
Standard of care suture

Study groups in NCT06063577
Study group	Role	What they receive
Stratafix Group	Active comparator	Stratafix Receives: Device: Stratafix suture
Control Group	Placebo comparator	Standard of care Receives: Device: Standard of care suture

What is being measured

The primary outcome is the main question the study is designed to answer.

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

Secondary outcomes (4)

Safety of stratafix sutures compared to standard of care wound closure
Assessing adverse events related to the suture
Measured: From enrollment to end of study participation at 12 months
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)
Measured: "Month 1," "Month 3," "Month 6," "Month 12"
Change in quality of life
Functional Assessment of Cancer Therapy-G (FACT-G) questionnaire (a 27-item questionnaire designed to measure four domains of HRQOL in cancer patients: Physical, social, emotional, and functional well-being.)
Measured: "Day 1," "Month 1," "Month 3," "Month 6," "Month 12"
Post operative pain
Visual analog score
Measured: From enrollment to end of study participation at 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Dec 2023Dec 2026

First posted2 Oct 2023
Study start1 Dec 2023
Primary completionDec 2026 (estimated)
Study completionDec 2026 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for C.Surgical Procedure; Disruption of Wound, SutureStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Participant
Enrolment: 100 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06063577
Sponsor's protocol ID: 001-2023
Acronym: STRATA-G
Status last verified: Jan 2024
First submitted: 2 Sep 2023
Last updated: 2 Feb 2024
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: No

Study at a glance

From the registry record, last updated by the sponsor on 2 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized Controlled Trial Evaluating the Use of Stratafix Symmetric™ to Prevent Incisional Hernia in Gastrointestinal and Abdominal Surgery
ClinicalTrials.gov ID: NCT06063577
Acronym / sponsor ID: STRATA-G / 001-2023
Conditions: C.Surgical Procedure; Disruption of Wound, Suture
Study type: Interventional
Recruitment status: Recruiting
Enrolment: 100 participants (estimated)
Lead sponsor: West Michigan Cancer CenterUniversity, hospital or other
Collaborators: Ethicon, Inc.
Study start: 1 Dec 2023 (actual)
Primary completion: Dec 2026 (estimated)
Study completion: Dec 2026 (estimated)
First posted: 2 Oct 2023 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (participant)
Number of arms: 2

Arm	Type	Receives
Stratafix Group	Active comparator	Device: Stratafix sutureStratafix
Control Group	Placebo comparator	Device: Standard of care sutureStandard of care

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

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.

Key exclusion criteria (3 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Stratafix sutureStratafix symmetric suture	Device	Stratafix Group
Standard of care sutureStandard of care suture	Device	Control Group

Primary outcome

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

4 secondary outcomes

Safety of stratafix sutures compared to standard of care wound closure
Time frame: From enrollment to end of study participation at 12 months
Change in quality of life
Time frame: "Month 1," "Month 3," "Month 6," "Month 12"
Change in quality of life
Time frame: "Day 1," "Month 1," "Month 3," "Month 6," "Month 12"
Post operative pain
Time frame: From enrollment to end of study participation at 12 months

Results and safety

This study is still under way. Results are not available in the source record yet.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 2 Feb 2024.
Individual participant dataSharing planned: No

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.

Wendi Mitchell contact

269-373-7443

research@wmcc.org

Gitonga Munene principal investigator

West Michigan Cancer Center

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Stratafix suture in people with C.Surgical Procedure; Disruption of Wound, Suture, run by West Michigan Cancer Center at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 2 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Wendi Mitchell (269-373-7443, research@wmcc.org), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of participants who develop ventral incisional hernia (time frame: From enrollment to end of study participation at 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06063577.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Feb 2024.