Observational Biologic or Prosthetic Mesh

Prospective, Observational Trial of Biological or Prosthetic Mesh for Open Ventral Hernia Repair

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.

Study Overview

• Status: Terminated
• Conditions: Ventral Incisional Hernia
• Intervention / Treatment: Device: Mesh for hernia repair

Detailed Description

Incisional hernias are very common, leading to over 380,000 operative repairs done annually. Despite the commonality of this problem, there has been no single operative repair that has become the standard. This is due to the high recurrence rates with all types of repairs, especially primary suture repair. Because of this, most repairs are done with some type of mesh, either made out of a prosthetic material or biologic material. Mesh repairs, however, have their own problems, namely surgical site infections and potential bowel erosion. Potential complications associated with prosthetic mesh for hernia repairs include: adverse reactions to the mesh, mesh erosion, stricture formation, adhesions resulting in bowel obstruction, enterocutaneous fistulas, injuries to nearby organs, nerves or blood vessels, infection, chronic pain and hernia recurrence. Potential complications associated with biological mesh include: adverse inflammatory response, laxity, eventration, and recurrent herniation. To address these mesh related complications, the separation of components technique was developed to reduce tension on the midline repair and the underlay technique was developed to place the mesh in the retrorectus space. Nevertheless, this technique still has a significant recurrence rate.

Therefore, the purpose of this study is to evaluate the effectiveness of biological or prosthetic mesh in incisional hernia repair, by assessing the associated rates of hernia recurrence and complications.

• Study Type: Observational
• Enrollment (Actual): 28

Contacts and Locations

Study Locations

• United States
  • Florida
    • Tampa, Florida, United States, 33606
      • Tampa General Hospital
    • Tampa, Florida, United States, 33606
      • University of South Florida - South Tampa Campus
    • Tampa, Florida, United States, 33612
      • University of South Florida Morsani Center for Advanced Health Care

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Patients requiring open ventral hernia repair.

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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; Permacol, Parietex, Progrip, Strattice Perforated, and Surgimend.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Incidence of ventral hernia recurrence	2 years from study ventral hernia repair

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to ventral hernia recurrence		2 years from study ventral hernia repair
Incidence of wound complications	Complications of interest: surgical site infections, seroma formation, and wound dehiscence or skin separation	90 days from study ventral hernia repair
Incidence of enterocutaneous fistula formation		2 years from study ventral hernia repair
Mean Carolinas Comfort Scale score	Patient-centered outcome assessing hernia symptoms - minimum score 0 and maximum total score 115	2 years from study ventral hernia repair
Mean Visual Analog Scale score	Patient-centered outcome - pain score measured by a line in millimeters (0 for no pain and 10 for worst pain imaginable)	2 years from study ventral hernia repair
Mean mesh deployment time	Defined as the time mesh preparation starts to time mesh placement ends	during surgery
Mean procedure time	Defined as time of incision to time of closure	during surgery
Mean total cost of hospitalization for primary admission	Defined as cost from surgery to hospital discharge	From date of surgery to date of hospital discharge (approximately 3 days)
Mean total cost of surgery for primary admission	Defined as cost from preoperative preparation to anesthesia discharge	during surgery
Mean total cost of narcotic usage for primary admission	Defined as cost from narcotic use from surgery to hospital discharge	From date of surgery to date of hospital discharge (approximately 3 days)
Mean total cost of readmissions	any hospital readmissions related to ventral hernia complications or recurrence	2 years from study ventral hernia repair

Collaborators and Investigators

• Sponsor: University of South Florida
• Collaborators: Integra LifeSciences Corporation

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (ACTUAL): February 11, 2019
• Primary Completion (ACTUAL): June 11, 2021
• Study Completion (ACTUAL): June 11, 2021

Study Registration Dates

• First Submitted: October 10, 2017
• First Submitted That Met QC Criteria: October 20, 2017
• First Posted (ACTUAL): October 23, 2017

Study Record Updates

• Last Update Posted (ACTUAL): October 6, 2021
• Last Update Submitted That Met QC Criteria: September 28, 2021
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Keywords: mesh; biologic; prosthetic
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pathological Conditions, Anatomical; Hernia; Incisional Hernia
• Other Study ID Numbers: CA2017-003

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No