Stratafix Suture for Preventing Incisional Hernia

(STRATA-G Trial)

Overseen By Wendi Mitchell

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: West Michigan Cancer Center

Disqualifiers: Hemodynamic instability, Previous VIH, Mental condition, others

Compensation: Varies

Number of Visits: 2

Duration: 1 day

100 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a special type of suture called Stratafix Symmetric™ to determine if it prevents hernias more effectively than regular stitches after surgery. It focuses on individuals undergoing major surgeries related to the liver, pancreas, bile ducts, or other cancer-related procedures. Patients at West Michigan Cancer Center scheduled for these surgeries might qualify for this trial. The goal is to discover if the new suture can reduce complications and improve recovery. As an unphased trial, this study provides a unique opportunity to contribute to medical advancements and potentially benefit from cutting-edge surgical techniques.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that the Stratafix Symmetric™ suture is safe for preventing incisional hernia?

Research has shown that Stratafix Symmetric™ stitches are generally well-accepted by patients. Studies have found that these stitches hold wounds together better than regular stitches, aiding more effective healing.

Some studies examined patient recovery after surgeries using Stratafix. The results indicated that the stitches performed well without causing major issues. While no treatment is completely risk-free, available evidence suggests that Stratafix is safe for people.

For those considering joining a trial with Stratafix, these findings are encouraging. Always consult with the trial team and your doctor to understand all the details and how they may apply to you. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about Stratafix Symmetric™ because it's designed to enhance wound closure and potentially reduce the risk of incisional hernias after surgery. Unlike traditional sutures, which can sometimes lead to uneven tension across the wound, Stratafix uses a knotless design with barbed sutures that help distribute tension more evenly. This unique feature could lead to stronger, more reliable wound healing and fewer complications. By improving the surgical outcome, Stratafix has the potential to set a new standard in post-operative care for minimizing incisional hernias.

What evidence suggests that Stratafix Symmetric™ sutures are effective for preventing incisional hernia?

Research has shown that Stratafix Symmetric™ sutures, which participants in this trial may receive, might help prevent incisional hernias. Studies have found that these sutures provide a strong and secure closure, crucial for healing and reducing wound complications. The barbed design of Stratafix holds the tissue in place without knots, making it suitable for areas under significant tension. Early experiences with this type of suture have shown promising results in maintaining tight tissue closure, which helps prevent hernias. Additionally, these sutures offer antibacterial protection, adding extra safety. ^{1 3 4 6 7}

Who Is on the Research Team?

Gitonga Munene, MD

Principal Investigator

West Michigan Cancer Center

Are You a Good Fit for This Trial?

This trial is for adults over 18 who are undergoing liver, pancreas, biliary or gastrointestinal surgery, or other major oncological surgeries at West Michigan Cancer Center. They must be able to understand the study and agree to participate. People with hemodynamic instability after surgery, a history of VIH (presumably HIV), or mental conditions affecting study comprehension cannot join.

Inclusion Criteria

I am having surgery for cancer in my liver, pancreas, bile ducts, or gastrointestinal tract.

Participant is a current patient at West Michigan Cancer Center

I am willing and able to sign a consent form before surgery.

Exclusion Criteria

Participant has history of previous VIH

I am unable to understand the study due to a mental condition.

I was stable after my surgery.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo gastrointestinal and abdominal surgery using either Stratafix Symmetric™ sutures or standard laparotomy closure sutures

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety, development of ventral incisional hernia, post-operative pain, and quality of life

12 months

Visits at Day 1, Month 1, Month 3, Month 6, Month 12

What Are the Treatments Tested in This Trial?

Interventions

• Standard of care suture
• Stratafix Symmetric™

Trial Overview The trial compares Stratafix Symmetric™ sutures against standard sutures used in closing surgical incisions from abdominal operations. The goal is to see if Stratafix can better prevent complications like incisional hernias and wound dehiscence.

How Is the Trial Designed?

Group I: Stratafix Group Active Control 1 Intervention

Stratafix

Group II: Control Group Placebo Group 1 Intervention

Standard of care

Standard of care suture is already approved in European Union, United States, Canada, Japan, China, Switzerland for the following indications:

Approved in European Union as Standard laparotomy closure sutures for:

• General soft tissue approximation and/or ligation
• Abdominal wound closure
• Hernia repair
• Sternal closure

Approved in United States as Standard laparotomy closure sutures for:

• General soft tissue approximation and/or ligation
• Abdominal wound closure
• Hernia repair
• Sternal closure
• Ophthalmic procedures
• Cardiovascular procedures
• Neurological procedures
• Orthopedic procedures
• Dental procedures

Approved in Canada as Standard laparotomy closure sutures for:

• General soft tissue approximation and/or ligation
• Abdominal wound closure
• Hernia repair
• Sternal closure

Approved in Japan as Standard laparotomy closure sutures for:

• General soft tissue approximation and/or ligation
• Abdominal wound closure
• Hernia repair
• Sternal closure

Approved in China as Standard laparotomy closure sutures for:

• General soft tissue approximation and/or ligation
• Abdominal wound closure
• Hernia repair
• Sternal closure

Approved in Switzerland as Standard laparotomy closure sutures for:

• General soft tissue approximation and/or ligation
• Abdominal wound closure
• Hernia repair
• Sternal closure

Who Is Running the Clinical Trial?

West Michigan Cancer Center

Lead Sponsor

Trials

2

Recruited

170+

Ethicon, Inc.

Industry Sponsor

Trials

95

Recruited

62,300+

Tim Schmid

Ethicon, Inc.

Chief Executive Officer since 2023

Undergraduate degree from the University of Western Ontario, MBA from Richmond University in the United Kingdom

Nancy Sabin

Ethicon, Inc.

Chief Medical Officer

MBA from the University of Pennsylvania’s Wharton School of Business, B.S. in Engineering from Duke University

Published Research Related to This Trial

In a study of 100 pregnant patients, using a barbed suture (STRATAFIX) for closing uterine incisions during cesarean sections significantly reduced closure time compared to a conventional smooth suture (Vicryl), with times of 224 seconds versus 343 seconds, respectively.

The barbed suture group also required fewer additional sutures for hemostasis (2 patients) compared to the smooth suture group (12 patients), indicating a potential advantage in surgical efficiency and effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Barbed sutures versus conventional sutures for uterine closure at cesarean section; a randomized controlled trial. Zayed, MA., Fouda, UM., Elsetohy, KA., et al.[2022]

Using a combination of stainless steel wires and absorbable materials for sternal closure can enhance biocompatibility and promote faster wound healing, potentially reducing complications after surgery.

The recommended suturing technique focuses on minimizing tension on the skin, which helps to achieve smoother wound edges and may prevent the formation of large scars.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Ideal suture methods for skin, subcutaneous tissues and sternum]. Ogawa, R.[2012]

In a study of 150 patients, the new suture material MonoMax® showed a wound infection or burst abdomen rate of 7.3%, which is comparable to the 11.3% rate in the control group using other sutures, indicating its safety.

One year post-surgery, incisional hernias occurred in 14.0% of patients using MonoMax®, compared to 21.3% in the control group, suggesting that MonoMax® may be more effective in reducing hernia rates.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of the safety and efficacy of MonoMax® suture material for abdominal wall closure after primary midline laparotomy-a controlled prospective multicentre trial: ISSAAC [NCT005725079]. Albertsmeier, M., Seiler, CM., Fischer, L., et al.[2022]

The STRATAFIX Symmetric PDS Knotless Tissue Control Device, a novel barbed suture, was tested against conventional Coated VICRYL suture in a study involving 20 cadaver knees, showing that it provided improved watertight closure during dynamic conditions.

While both sutures were similar in watertightness under static conditions, the continuous barbed suture outperformed the interrupted conventional suture in all subsequent dynamic testing phases, indicating its potential for better performance in high-tension areas.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparing the Water-Tight Closure of Barbed and Conventional Suture Under Static and Dynamic Conditions in an Ex-Vivo Human Knee Arthrotomy Model. Fillingham, YA., Matonick, JP., Mendoza, V., et al.[2022]

Polydioxanone monofilament absorbable sutures demonstrate prolonged breaking strength retention and minimal tissue reaction, making them ideal for situations requiring long-lasting suture integrity.

In clinical evaluations, polydioxanone sutures were rated significantly superior to gut sutures across all categories, supporting their use as the preferred choice for general surgical applications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Studies on the efficacy and safety of polydioxanone monofilament absorbable suture. Lerwick, E.[2009]

The MONOFIX absorbable barbed suture device demonstrated equivalent biomechanical strength to widely used barbed sutures (V-Loc 180 and Stratafix) in a porcine model, indicating it can effectively hold tissue together post-surgery.

Histological evaluations showed no significant difference in tissue reaction between MONOFIX and Stratafix, suggesting that MONOFIX is a safe alternative with similar tissue compatibility.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

In Vivo Comparison of MONOFIX, A Novel Barbed Suture with a Triangular Stopper, with Pre-existing Products in a Porcine Model. Kim, J., Eom, HJ., Shin, H., et al.[2020]

In a study involving 18 pigs and 192 skin incisions, knotless, absorbable barbed sutures demonstrated comparable wound strength and tissue reaction to traditional absorbable monofilament sutures, indicating their efficacy for cosmetic closures.

Among the barbed sutures tested, the V-Loc 90 device showed the least tissue reaction over time, suggesting it may be a safer option for minimizing inflammation during the healing process.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An in vivo comparison of barbed suture devices and conventional monofilament sutures for cosmetic skin closure: biomechanical wound strength and histology. Zaruby, J., Gingras, K., Taylor, J., et al.[2016]

A standardized fascial closure technique using slowly absorbable monofilament suture significantly reduced the occurrence of incisional hernias after emergency laparotomy, from 27.0% in the historic cohort to 15.0% in the standardized technique group.

The study included 465 patients with a 77% response rate, indicating that implementing a consistent surgical method can lead to better long-term outcomes in preventing complications like incisional hernias.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Reduced rate of incisional hernia after standardized fascial closure in emergency laparotomy. Thorup, T., Tolstrup, MB., Gögenur, I.[2020]

In a study involving 200 consecutive surgical procedures, the use of polydioxanone sutures for closing abdominal wounds resulted in zero cases of wound dehiscence or evisceration, indicating high safety and efficacy.

The incidence of incisional hernia was low, at 2.9% for vertical midline wounds and 3.6% for transverse incisions, further supporting the effectiveness of polydioxanone sutures in surgical wound closure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Closure of abdominal wounds with polydioxanone. A prospective study. Schoetz, DJ., Coller, JA., Veidenheimer, MC.[2019]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06063577

Use of Stratafix Symmetric™ to Prevent Incisional Hernia in ... Determine the safety of Stratafix Symmetric™ sutures compared to standard laparotomy closure sutures and the impact on quality of life and level of pain.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11894428/

Clinical Outcomes Among Patients Undergoing Open ... This study assessed the cumulative incidence of clinical outcomes among patients undergoing procedures incorporating the STRATAFIX Symmetric PDS ...

3. jnjmedtech.com jnjmedtech.com/system/files/pdf/127703-191114%20ANZ%20SFX%20Symmetric%20Sales%20Aid%20.pdf

STRATAFIX™ Symmetric PDS™ Plus Knotless Tissue Control ... Why is a strong fascial closure important? post-op—however, a strong fascial closure is critical for preventing wound complications during healing12,13: • ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10962887/

Initial Experience with Unidirectional Barbed Suture for ... This study details our initial experience with unidirectional barbed suture–only repair of abdominal donor site fascia.

5. jnjmedtech.com jnjmedtech.com/en-US/product/stratafix-spiral-knotless-tissue-control-device

STRATAFIX™ Spiral Knotless Tissue Control Devices STRATAFIX™ Spiral - Ethicon's market leading barbed suture with antibacterial protection provides strong, secure closure appropriate for high-tension areas.

6. jnjmedtech.com jnjmedtech.com/en-US/product/stratafix-symmetric-pds-plus-knotless-tissue-control-device

STRATAFIX™ Knotless Tissue Control Device | Ethicon STRATAFIX Symmetric PDS Plus Devices demonstrated superior tissue holding strength compared to interrupted technique with Coated VICRYL™ (polyglactin 910) ...

7. researchgate.net researchgate.net/publication/316750765_A_High-Strength_Absorbable_Antibacterial_Knotless_Tissue_Control_Device_for_Fascial_Closure

(PDF) A High-Strength, Absorbable, Antibacterial Knotless ... PDF | Purpose of Review This review provides an overview of the STRATAFIX™ SYMMETRIC PDS™ Plus Knotless Tissue Control Device design and performance.