Gentrix™ Versus Biological or Prosthetic Mesh

NCT03034213 | Terminated FDA Device

• 1 other identifier: CA2017-002
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 3

Brief Summary

The hypothesis for this study is complex incisional hernia repair using the separation of components technique reinforced with retrorectus placement of Gentrix™ Surgical Matrix will lead to fewer incisional hernia recurrences and fewer wound complications compared to the same incisional hernia repair techniques reinforced with other prosthetic or biologically-derived mesh.

Conditions

Ventral Incisional Hernia

Keywords

mesh

Outcome Measures

Primary Outcomes (1)

• Incidence of incisional hernia recurrence

  2 years from study incisional hernia repair

Secondary Outcomes (11)

• Time to incisional hernia recurrence

  2 years from study incisional hernia repair

• Incidence of wound complications

  90 days from study incisional hernia repair

• Incidence of enterocutaneous fistula formation

  2 years from study incisional hernia repair

• Mean Carolinas Comfort Scale score

  2 years from study incisional hernia repair

• Mean Visual Analog Scale score

  2 years from study incisional hernia repair

Study Arms (2)

Treatment

ACTIVE COMPARATOR

Gentrix(TM) Surgical Matrix

Device: Gentrix™ Surgical Matrix (Treatment)

Control

ACTIVE COMPARATOR

Standard of care mesh

Device: Permacol, Parietex, Progrip, Strattice Perforated, or Surgimend (Control)

Interventions

Gentrix™ Surgical Matrix (Treatment) DEVICE

Gentrix™ Surgical Matrix will be placed in the retrorectus space. The anterior midline fascia will be closed with long-acting absorbable suture either with a running or interrupted manner as per the surgeon's discretion.

Treatment

Permacol, Parietex, Progrip, Strattice Perforated, or Surgimend (Control) DEVICE

A biological or prosthetic mesh (Permacol, Parietex, Progrip, Strattice Perforated, or Surgimend) will be placed in the retrorectus space. The anterior midline fascia will be closed with long-acting absorbable suture either with a running or interrupted manner as per the surgeon's discretion.

Control

Eligibility Criteria

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

You may qualify if:

• Male and female patients ≥ 18 years old.
• American Society of Anesthesiologists (ASA) physical status classification of I, II, III or IV.
• Able to provide informed consent in English or Spanish.
• Stated willingness to comply with all study procedures and availability for the duration of the study.
• Body Mass Index (BMI) =\< 45.
• Incisional hernia from a midline incision ≥ 4 cm in greatest diameter, or any recurrent incisional hernia.

You may not qualify if:

• Any other type of ventral hernia, such as umbilical, epigastric or Spigelian hernia.
• Pregnant, breastfeeding, or unwilling to practice birth control during participation in the study, if applicable.
• Allergy or hypersensitivity to materials in porcine-based study products, biological or prosthetic meshes, or personal preference.
• Contraindications to general anesthesia.
• Patient undergoing any emergency surgery prior to treatment.
• Severe comorbid conditions likely to limit survival to less than 3 years in the opinion of the Investigator.
• 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 with abdominal wall mobilization or component separation; confirmed intra-operatively.
• History of malignancy within the past 5 years except for non-melanoma skin cancer.
• Known active malignancy present and/or had chemotherapy 12 weeks prior to screening or planned chemotherapy within 12 weeks of treatment with exception of basal cell carcinoma, squamous cell carcinoma, or prostate cancer in situ.
• Cirrhosis with or without ascites.
• Received high dose steroids (\>/=100mg of prednisone) within the past 6 weeks of screening.
• Uncontrolled diabetes (i.e. known HbA1C value \> 7% within the prior 6 weeks of the Screening Visit).
• 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.
• Serious or active medical or psychiatric condition which, in the opinion of the Investigator, may interfere with treatment, assessment, or compliance with the protocol.

Sponsors & Collaborators

• University of South Florida: lead
• Integra LifeSciences Corporation: collaborator

Study Sites (3)

Tampa General Hospital

Tampa, Florida, 33606, United States

Location

University of South Florida - South Tampa Campus

Tampa, Florida, 33606, United States

Location

University of South Florida Morsani Center for Advanced Health Care

Tampa, Florida, 33612, United States

Location

Related Publications (8)

• FitzGerald JF, Kumar AS. Biologic versus Synthetic Mesh Reinforcement: What are the Pros and Cons? Clin Colon Rectal Surg. 2014 Dec;27(4):140-8. doi: 10.1055/s-0034-1394155.

  PMID: 26106284 BACKGROUND

• Zhou XH, Melfi CA, Hui SL. Methods for comparison of cost data. Ann Intern Med. 1997 Oct 15;127(8 Pt 2):752-6. doi: 10.7326/0003-4819-127-8_part_2-199710151-00063.

  PMID: 9382393 BACKGROUND

• Holihan JL, Alawadi Z, Martindale RG, Roth JS, Wray CJ, Ko TC, Kao LS, Liang MK. Adverse Events after Ventral Hernia Repair: The Vicious Cycle of Complications. J Am Coll Surg. 2015 Aug;221(2):478-85. doi: 10.1016/j.jamcollsurg.2015.04.026. Epub 2015 May 9.

  PMID: 26206646 RESULT

• Fekkes JF, Velanovich V. Amelioration of the effects of obesity on short-term postoperative complications of laparoscopic and open ventral hernia repair. Surg Laparosc Endosc Percutan Tech. 2015 Apr;25(2):151-7. doi: 10.1097/SLE.0000000000000100.

  PMID: 25222715 RESULT

• Poulose BK, Shelton J, Phillips S, Moore D, Nealon W, Penson D, Beck W, Holzman MD. Epidemiology and cost of ventral hernia repair: making the case for hernia research. Hernia. 2012 Apr;16(2):179-83. doi: 10.1007/s10029-011-0879-9. Epub 2011 Sep 9.

  PMID: 21904861 RESULT

• Fischer JP, Wink JD, Tuggle CT, Nelson JA, Kovach SJ. Wound risk assessment in ventral hernia repair: generation and internal validation of a risk stratification system using the ACS-NSQIP. Hernia. 2015 Feb;19(1):103-11. doi: 10.1007/s10029-014-1318-5. Epub 2014 Dec 4.

  PMID: 25472771 RESULT

• Heniford BT, Walters AL, Lincourt AE, Novitsky YW, Hope WW, Kercher KW. Comparison of generic versus specific quality-of-life scales for mesh hernia repairs. J Am Coll Surg. 2008 Apr;206(4):638-44. doi: 10.1016/j.jamcollsurg.2007.11.025. Epub 2008 Feb 1.

  PMID: 18387468 RESULT

• Nielsen K, Poelman MM, den Bakker FM, van der Ploeg T, Bonjer HJ, Schreurs WH. Comparison of the Dutch and English versions of the Carolinas Comfort Scale: a specific quality-of-life questionnaire for abdominal hernia repairs with mesh. Hernia. 2014 Aug;18(4):459-64. doi: 10.1007/s10029-013-1173-9. Epub 2013 Oct 29.

  PMID: 24166693 RESULT

MeSH Terms

Interventions

Therapeutics

Study Officials

• Vic Velanovich, MD

  University of South Florida

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 25, 2017
• First Posted: January 27, 2017
• Study Start: October 6, 2017
• Primary Completion: June 16, 2021
• Study Completion: June 16, 2021
• Last Updated: September 29, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)