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

Trial Summary

What is the purpose of this trial?

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

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 data supports the effectiveness of the treatment Stratafix Suture for preventing incisional hernia?

Research shows that using slowly absorbable monofilament sutures, like those in Stratafix, can reduce the occurrence of incisional hernias after surgeries. Additionally, polydioxanone sutures, a component of Stratafix, are known for their strength and minimal tissue reaction, making them reliable for surgical use. ^{1 2 3 4 5}

Is the Stratafix suture generally safe for use in humans?

Research shows that polydioxanone, a type of absorbable suture used in Stratafix, is safe for closing abdominal wounds, with no cases of wound reopening or internal organs protruding through the wound. Incisional hernias occurred in a small percentage of cases, but overall, the suture material is considered safe. ^{2 3 4 6 7}

How is the Stratafix Suture treatment different from other treatments for preventing incisional hernia?

The Stratafix Suture is unique because it uses a barbed design that doesn't require knots, which can provide stronger and more secure closure in high-tension areas like fascia (a layer of tissue beneath the skin). This design may help reduce the risk of incisional hernias by providing a more reliable closure compared to traditional smooth sutures. ^{3 4 7 8 9}

Research Team

Gitonga Munene, MD

Principal Investigator

West Michigan Cancer Center

Eligibility Criteria

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 18 years old or older.

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

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

Treatment Details

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.

Participant Groups

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

Findings from Research

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 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 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]

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]

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]

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]

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]

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]

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]

References

1. France pubmed.ncbi.nlm.nih.gov

Reduced rate of incisional hernia after standardized fascial closure in emergency laparotomy. [2020]

2. Germany 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]. [2022]

3. United States 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. [2020]

4. Japan pubmed.ncbi.nlm.nih.gov

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

5. United States pubmed.ncbi.nlm.nih.gov

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

6. United States pubmed.ncbi.nlm.nih.gov

Closure of abdominal wounds with polydioxanone. A prospective study. [2019]

7. England 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. [2016]

8. United States 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. [2022]

9. England pubmed.ncbi.nlm.nih.gov

Barbed sutures versus conventional sutures for uterine closure at cesarean section; a randomized controlled trial. [2022]