Multi-Center Study To Examine The Use Of Flex HD® And Strattice In The Repair Of Large Abdominal Wall Hernias

NCT01987700 | Completed Phase 4

• 1 other identifier: MTF 01-13
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 3

Brief Summary

The primary objective of this study is to examine and compare the outcomes associated with the use of Flex HD®, a human acellular dermal matrix (HADM), and Strattice™, a porcine acellular dermal matrix, (PADM) when used as a reinforcing material in the repair of large complicated abdominal wall hernias.

Conditions

Hernia of Abdominal Wall

Keywords

Abdominal Hernia Repair; Dermal Allograft; Mesh; Component Separation

Outcome Measures

Primary Outcomes (1)

• Incidence of true hernia recurrence (True defect in the mesh/repair in which intra-abdominal contents are protruding through the defect) at or before 1 year

  Quantitative data collected over a one-year period: * Recurrent hernias requiring surgical intervention * Evidence of Eventration/Hernia Recurrence (Radiographic) * Fluid collection (Seroma, Hematoma) * Surgical Site Infections * Systemic Infections * Enterocutaneous Fistula * Dehiscence * Mesh Failure requiring partial or total removal

  12 months

Secondary Outcomes (2)

• Incidence of Functional Hernia Recurrence

  12 months

• Patient Satisfaction

  3 months, 6 months, 12 months

Study Arms (4)

FLEX-HD (underlay)

ACTIVE COMPARATOR

FLEX-HD human acellular dermal matrix applied using an underlay technique

Device: FLEX-HD

FLEX-HD (overlay)

ACTIVE COMPARATOR

FLEX-HD human acellular dermal matrix applied using an overlay technique

Device: FLEX-HD

Strattice (underlay)

ACTIVE COMPARATOR

Strattice porcine acellular dermal matrix applied using an underlay technique

Device: Strattice

Strattice (overlay)

ACTIVE COMPARATOR

Strattice porcine acellular dermal matrix applied using an overlay technique

Device: Strattice

Interventions

FLEX-HD DEVICE

Also known as: Human Acellular Dermal Matrix (HADM)

FLEX-HD (overlay); FLEX-HD (underlay)

Strattice DEVICE

Also known as: Porcine Acellular Dermal Matrix (PADM)

Strattice (overlay); Strattice (underlay)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years of age or greater
• Have a BMI \<40
• Have a hernia of at least 200 cm\^2
• Have no contraindications to test material(s)
• Have a life expectancy greater than 1 year in the opinion of the Investigator
• Able to provide informed consent
• Able and willing to return for scheduled study visits over 1 year post-operatively (following research related surgery)

You may not qualify if:

• \< 18 years of age
• Subject is determined to have an America Society of Anesthesiologists' (ASA) physical class of 4, 5, or 6.
• Have a BMI \> 40
• Have a hernia \< 2002 cm
• Have abdominal loss of domain such that the operation would be impractical or would adversely affect respiratory or cardiovascular function to an unacceptable degree in the opinion of the Investigator
• Inability to close the fascia primarily without abdominal wall mobilization or component separation
• Participation in an investigational drug or device study within the past 6 weeks prior to enrollment into this trial
• Have active necrotizing fasciitis or any other known active local or systemic infection
• Have a known collagen metabolism disorder or any medical condition that could interfere with normal tissue healing process as determined by the Investigator
• Have a known active malignancy present and/or had chemotherapy 12 weeks prior to screening or planned chemotherapy within 12 weeks of enrollment with the exception of BCC or SCC
• Have known moderate to severe cirrhosis which in the opinion of the Investigator would impact the outcome of this trial
• Have a life expectancy less than 1 year.
• Be unable to participate in the informed consent process
• Be unable or unwilling to return for scheduled study visits over the 1 year post-operative assessment period
• Subject's ventral hernia is related to an organ transplant surgery

Sponsors & Collaborators

• Musculoskeletal Transplant Foundation: lead
• Washington University School of Medicine: collaborator
• Pines Surgical: collaborator
• Meridian Healthcare System: collaborator

Study Sites (3)

Pines Surgical

Pembroke Pines, Florida, 33028, United States

Location

Washington University in St Louis, Barnes Jewish Hospital

St Louis, Missouri, 63110, United States

Location

CentraState Medical Center

Freehold, New Jersey, 07728, United States

Location

MeSH Terms

Conditions

Hernia, Abdominal

Condition Hierarchy (Ancestors)

Hernia; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Grant Bochicchio, MD, MPH

  Washington University School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 13, 2013
• First Posted: November 19, 2013
• Study Start: July 1, 2013
• Primary Completion: June 30, 2018
• Study Completion: August 25, 2018
• Last Updated: September 19, 2018

Record last verified: 2015-09

Locations

US (3)