Observational Biologic or Prosthetic Mesh

NCT03317665 | Terminated FDA Device

• 1 other identifier: CA2017-003
• Study Type: observational
• Target: 28
• Locations: 1 country
• Sites: 3

Brief Summary

The purpose of this study is to assess the incidence of hernia recurrence with the use of biologic and prosthetic mesh in ventral hernia repair.

Conditions

Ventral Incisional Hernia

Keywords

biologic; prosthetic; mesh

Outcome Measures

Primary Outcomes (1)

• Incidence of ventral hernia recurrence

  2 years from study ventral hernia repair

Secondary Outcomes (11)

• Time to ventral hernia recurrence

  2 years from study ventral hernia repair

• Incidence of wound complications

  90 days from study ventral hernia repair

• Incidence of enterocutaneous fistula formation

  2 years from study ventral hernia repair

• Mean Carolinas Comfort Scale score

  2 years from study ventral hernia repair

• Mean Visual Analog Scale score

  2 years from study ventral hernia repair

Study Arms (1)

Standard of care

Mesh for hernia repair: Standard of care products used by the Investigator for open ventral hernia repair procedure

Device: Mesh for hernia repair

Interventions

Mesh for hernia repair DEVICE

Permacol, Parietex, Progrip, Strattice Perforated, and Surgimend.

Standard of care

Eligibility Criteria

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

Study Population

Patients requiring open ventral hernia repair.

You may qualify if:

• Male and female patients \> 21 years old.
• 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.

You may not qualify if:

• 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, prosthetic or biological meshes, or personal preference.
• Male and female patients ≤ 21 years old
• 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 (9)

• 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 BACKGROUND

• 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 BACKGROUND

• 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 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

• 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

• 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 RESULT

• Aravot DJ, Banner NR, Khaghani A, Fitzgerald M, Radley-Smith R, Mitchell AG, Yacoub MH. Cardiac transplantation in the seventh decade of life. Am J Cardiol. 1989 Jan 1;63(1):90-3. doi: 10.1016/0002-9149(89)91082-5.

  PMID: 2642367 RESULT

MeSH Terms

Interventions

Herniorrhaphy

Intervention Hierarchy (Ancestors)

Plastic Surgery Procedures; Surgical Procedures, Operative

Study Officials

• Vic Velanovich, MD

  University of South Florida

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 10, 2017
• First Posted: October 23, 2017
• Study Start: February 11, 2019
• Primary Completion: June 11, 2021
• Study Completion: June 11, 2021
• Last Updated: October 6, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)