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

Completed · Phase 4

Conditions studied: Hernia of Abdominal Wall

In brief

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.

Key facts

Study ID

NCT01987700

Run by

Musculoskeletal Transplant Foundation

People needed

120

Starts

2013-07-01

Expected to finish

2018-08-25

Last updated by the study team

2018-09-19

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 18 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
• Received high dose steroids (≥100mg of prednisone) within the past 6 weeks
• Tobacco use within the past 6 weeks or positive serum cotinine test at time of admission
• Uncontrolled diabetes (i.e. known HbA1C value > 7%)
• History of drug addiction (recreational drugs, prescription drugs or alcohol) that in the Investigator's opinion may interfere with protocol assessments and/or the subject's ability to complete the required follow up
• Pregnancy and/or breastfeeding
• Enterocutaneous fistula
• Undergoing concomitant panniculectomy
• Ventral hernia repairs involving actively infected mesh removal
• Inability to obtain primary fascial closure (Intra-operatively)

Where it is running

• Pines Surgical — Pembroke Pines, Florida, United States
• Washington University in St Louis, Barnes Jewish Hospital — St Louis, Missouri, United States
• CentraState Medical Center — Freehold, New Jersey, United States

Full record on ClinicalTrials.gov

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