Stratafix Suture for Preventing Incisional Hernia
(STRATA-G Trial)
Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: West Michigan Cancer Center
Disqualifiers: Hemodynamic instability, Previous VIH, Mental condition, others
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.
12345Is 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.
23467How 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.
34789Eligibility 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.
+1 more
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.
Trial 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
Participant Groups
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.
2Treatment groups
Active Control
Placebo Group
Group I: Stratafix GroupActive Control1 Intervention
Stratafix
Group II: Control GroupPlacebo Group1 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
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
West Michigan Cancer CenterKalamazoo, MI
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Who Is Running the Clinical Trial?
West Michigan Cancer CenterLead Sponsor
Ethicon, Inc.Industry Sponsor
References
Reduced rate of incisional hernia after standardized fascial closure in emergency laparotomy. [2020]Emergency laparotomy is a high-risk procedure, and incisional hernia is a common complication. This study aimed to investigate whether a standardized fascial closure technique, using slowly absorbable monofilament suture in a ratio of at least 1:4, could reduce the long-term occurrence of incisional hernia after emergency laparotomy.
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]Different suture techniques and various suture materials are in use to close midline incisions after primary laparotomy. The ISSAAC study aimed to assess the safety and efficacy of the new ultra-long-term absorbable, elastic monofilament suture material MonoMax® for abdominal wall closure.
In Vivo Comparison of MONOFIX, A Novel Barbed Suture with a Triangular Stopper, with Pre-existing Products in a Porcine Model. [2020]MONOFIX, a new absorbable barbed suture device, has a triangular stopper at the end to hold the suture to the tissue without hooking the looped end or knotting. The aim of this study was to compare the biomechanical strength and histologic features of MONOFIX with other barbed suture devices using a porcine model.
[Ideal suture methods for skin, subcutaneous tissues and sternum]. [2012]Non-absorbable sternal closure methods such as stainless steel wiring have been widely used, but biocompatibility and osteoconductivity of absorbable materials have advantages in acceleration of wound healing. Combined use of stainless steel wires with absorbable materials may contribute to minimizing sternal complications.Fascial tension reduction sutures, where the tension is placed on the layer of deep fascia and superficial fascia, are recommended for skin/subcutaneous closure. This means that the use of dermal sutures is minimized;indeed, dermal sutures can be avoided altogether if the wound edges can be joined naturally under very small tension. We prefer 0, 2-0 polydioxanone sutures (PDS II) for deep/superficial fascia sutures, 4-0 or 5-0 PDS II for dermal sutures (if they are necessary), and 6-0 or 7-0 polypropylene or nylon sutures (Proline or Ethilon) for superficial sutures. The consequence of such suturing is that the wound edges are elevated smoothly with minimal tension on the dermis that appears to prevent the development of large scars.
Studies on the efficacy and safety of polydioxanone monofilament absorbable suture. [2009]Preclinical animal studies have clearly indicated that dyed and undyed polydioxanone monofilament absorbable sutures have prolonged breaking strength retention, a reliable absorption profile and minimal tissue reaction. The suture provides wound support throughout extended postoperative periods and is most useful in those situations in which prolonged suture integrity is desirable. Based upon these clinical studies, polydioxanone monofilament absorbable sutures must be considered as a reliable, easy to use suture material which fulfills all performance criteria. The over-all clinical results were excellent. Polydioxanone was rated as significantly superior to gut in every category evaluated. The results of this study support the claim that polydioxanone monofilament absorbable sutures are the suture of choice for general surgical use as well as in a variety of other clinical applications in which an absorbable suture is required.
Closure of abdominal wounds with polydioxanone. A prospective study. [2019]Polydioxanone, an absorbable synthetic monofilament suture, was used to close abdominal wounds in 200 consecutive operative procedures. All patients were followed up for one year. Despite a high incidence of risk factors for impaired wound healing, the incidence of dehiscence and evisceration was zero; incisional hernia occurred in 2.9% of vertical midline wounds and in 3.6% of transverse incisions. This new suture material is safe and effective for closure of abdominal wounds.
An in vivo comparison of barbed suture devices and conventional monofilament sutures for cosmetic skin closure: biomechanical wound strength and histology. [2016]Very little biomechanical or histological data exist in the peer-reviewed literature comparing absorbable monofilament sutures to commercially-available knotless, absorbable barbed suture devices for cosmetic closure of skin incisions.
Comparing the Water-Tight Closure of Barbed and Conventional Suture Under Static and Dynamic Conditions in an Ex-Vivo Human Knee Arthrotomy Model. [2022]Barbed suture has become popular for closure of the arthrotomy and overlying tissues in total knee arthroplasty. STRATAFIX Symmetric PDS Knotless Tissue Control Device, a unique and novel barbed suture, with barbs formed integral to the suture core provides greater suture strength than the more common cut barbed suture designs. It is the only barbed suture commercially available with an indication in high tension areas, such as fascia. The purpose of this study was to evaluate the use of this novel barbed suture in the formation of a water-tight arthrotomy closure, using a continuous suture pattern, compared to conventional Coated VICRYL (polyglactin 910) Suture, using an interrupted suture pattern, in a cadaveric knee arthrotomy.
Barbed sutures versus conventional sutures for uterine closure at cesarean section; a randomized controlled trial. [2022]Label="INTRODUCTION" NlmCategory="BACKGROUND">The aim of this randomized control trial was to compare the operative data and the early postoperative outcomes of cesarean sections in which the uterine incision was closed with a barbed suture (STRATAFIX™ Spiral PDO Knotless Tissue Control Device, SXPD2B405, Ethicon Inc.) with those of cesarean sections in which the uterine incision was closed with a conventional smooth suture (VICRYL™; Ethicon Inc.).