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Status:

COMPLETED

A Prospective Case Series Evaluating Surgimend Mp® In Patients Undergoing Complex Abdominal Hernia Repair

Lead Sponsor:

Washington University School of Medicine

Conditions:

Hernia, Ventral

Eligibility:

All Genders

18+ years

Phase:

NA

Brief Summary

Large abdominal wall hernias are surgically challenging to repair and often associated with significant postoperative complications. Risk factors associated with surgical site complications, such as i...

Detailed Description

Large abdominal wall hernias are surgically challenging to repair and often associated with significant postoperative complications. Risk factors associated with surgical site complications, such as i...

Eligibility Criteria

Inclusion

  • Men or women ≥ 18 years of age and able to give their own consent.
  • The subject is able and willing to comply with study procedures and a signed and dated informed consent is obtained.
  • The subject has a complex ventral hernia
  • The surgeon intends to use bioprosthetic mesh in the repair of the hernia
  • The hernia meets the definition of complex.
  • For this study a hernia defect will be considered complex if:
  • 1. a hernia defect is large enough to require component separation to achieve midline fascial closure under physiologic tension 5.2. or the surgical wound is class II -potentially contaminated or class III - contaminated without signs of infection as defined by the CDC wound classification (see Table 1) 5.3. or a patient classified as at risk for surgical site complications by having 2 or more of the following comorbidities:
  • Current smoker or recent history of smoking
  • Obesity (BMI ≥ 30)
  • Type I or Type II diabetes
  • Chronic Obstructive Pulmonary Disease (COPD)
  • Poor nutritional status as judged by the Investigator
  • Current immunosuppressive therapy
  • Current and/or recent (within 30 days of planned surgery) Corticosteriod use
  • Prior Mesh infection
  • Life expectancy of the patient is considered by the physician to be greater than at least 1 year
  • The subject has no known hypersensitivity to bovine collagen
  • The subject has no obvious condition interfering with their ability to comply with the treatment regimen
  • The subject is willing and capable of returning for all follow-up evaluations, in the opinion of the treating physician

Exclusion

  • Pre-Operative Exclusion:
  • \< 18 years of age
  • 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
  • Participation in an investigational drug or device study within the past 6 weeks prior to enrollment into this trial
  • Have a known collagen metabolism disorder or any medical condition that could interfere with normal tissue healing process as determined by the Investigator
  • Intra-Operative

Key Trial Info

Start Date :

January 3 2018

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

December 31 2022

Estimated Enrollment :

24 Patients enrolled

Trial Details

Trial ID

NCT03450473

Start Date

January 3 2018

End Date

December 31 2022

Last Update

February 15 2023

Active Locations (1)

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Page 1 of 1 (1 locations)

1

Barnes Jewish Hospital

St Louis, Missouri, United States, 63110