Complex Ventral Hernia Repair Using Biologic or Synthetic Mesh

NCT02041494 | Terminated Results DMC

• 2 other identifiers: UCSF-NIDDK-1R21DK093006-01A11R21DK093006-01A1
• Study Type: interventional
• Target: 165
• Locations: 1 country
• Sites: 1

Brief Summary

Hernias are often treated using a prosthetic mesh to add support to the healing wound. Prosthetic meshes have been used for decades to repair ventral hernias, level 1 data regarding which type of mesh to use is limited. The purpose of this study is to compare the effects, good and/or bad, of two types of prosthetic meshes: one that is made from pig skin (called a "biologic prosthetic"), and one that is made in a laboratory (called a "synthetic prosthetic"). This study will include some patients who have an infection in/near the hernia, and other patients who do not have an infection. We expect the synthetic mesh to be associated with a higher rate of early post-operative surgical site infection and fluid collections (seromas), while we expect the biologic mesh to be associated with a higher rate of recurrence.

Conditions

Hernia, Ventral

Keywords

Hernia; Ventral; Incisional; Abdominal; Herniorrhaphy; Recurrence; Infection; Mesh; Biologic; Synthetic

Outcome Measures

Primary Outcomes (1)

• Number of Patients Who Had a Recurrence of Hernia, at Anytime, up to Two Years Following Repair.

  Number of patients who had a recurrence of hernia, at anytime, up to two years following repair as determined by physical examination, ultrasound or CT scan.

  up to 24 months after surgery

Secondary Outcomes (1)

• Number of Patients Who Experienced Surgical Site Infections.

  30 days after surgery

Other Outcomes (5)

• Generic Measure of Health-related Quality of Life and Hernia-specific Measure of Quality of Life With a Focus on Abdominal Wall Function

  24 months after surgery

• Number of Surgical Site Occurrences

  Up to two years from surgery

• Number of Other Surgical Complications

  30 days after surgery

Study Arms (2)

Synthetic

ACTIVE COMPARATOR

Patients in this arm will have their ventral hernia repaired utilizing Ventralight, a synthetic prosthetic mesh made of polypropylene.

Device: Ventralight

Biologic

ACTIVE COMPARATOR

Patients in this arm will have their ventral hernia repaired utilizing Strattice, a biologic prosthetic mesh derived from porcine dermis.

Device: Strattice

Interventions

Ventralight DEVICE

Also known as: Ventralight ST Mesh, K101851

Synthetic

Strattice DEVICE

Also known as: LTM Surgical Mesh, K070560

Biologic

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Clinical evidence of a midline, ventral hernia, regardless of degree of wound contamination, with the exception of class IV wounds due to the presence/discovery of fecal peritonitis. Specifically, the repair will or will not involve a compromised surgical field in which gastrointestinal, biliary and/or genitourinary procedures will be performed. The surgical wound class may be classified as clean, or it may be classified as clean-contaminated, contaminated, or dirty-infected, due to the repair of an enterocutaneous fistula, takedown of an intestinal stoma and/or removal of infected mesh
• Age \>21
• Negative pregnancy test
• No allergic, religious or ethical objections to either polypropylene or porcine prosthetics
• Signed, witnessed informed consent to take part in the study

You may not qualify if:

• Lactating women
• Patients who are unable to commit to the follow evaluations over 24 months
• Severe malnutrition (serum albumin \<2.0 in the setting of a normal CRP)
• Use of an investigational agent within 1 month prior to study enrollment and/or planned during this study
• Presence of pre-existing parenchymal liver disease characterized by the presence of Child's Class C liver dysfunction (including all of the following: bilirubin ≥ 3.0 mg/dL; albumin ≤ 3.0 mg/dL; refractory ascites; encephalopathy or coma; and poor nutritional status)
• Immunocompromised patients, as evidenced by: administration of high doses of corticosteroids (i.e. doses ≥ 1.5 mg/kg/day of prednisone or equivalent) within 72 hours before study enrollment; status post solid organ transplant or bone marrow transplant and experiencing acute organ rejection or bone marrow failure or rejection; evidence of neutropenia (absolute neutrophil count ≤ 500 cells/mm3 (≤ 500 x 106 cells/L); chemotherapy or radiation therapy within 90 days before study enrollment; known AIDS; any disease sufficiently advanced to suppress resistance to infection (including, but not limited to leukemia, lymphoma or hypogammaglobulinemia); administration of immunoglobulin of G-CSF within 90 days before study enrollment
• Ascites refractory to medical management
• Presence of an underlying disease/injury with life expectancy less than two years and/or severe underlying disease that would preclude study entry (e.g. known malignancy)
• Wound Classification IV due to the presence/discovery of fecal peritonitis. Other cases of wound class IV including presence of purulent inflammation, soft tissue/mesh infection, or visceral perforation resulting in a contained fistula (e.g. enterocutaneous fistula) are still considered eligible for enrollment.

Sponsors & Collaborators

• Hobart Harris: lead
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator

Study Sites (1)

University of California, San Francisco

San Francisco, California, 94131, United States

Location

Related Publications (1)

• Harris HW, Primus F, Young C, Carter JT, Lin M, Mukhtar RA, Yeh B, Allen IE, Freise C, Kim E, Sbitany H, Young DM, Hansen S. Preventing Recurrence in Clean and Contaminated Hernias Using Biologic Versus Synthetic Mesh in Ventral Hernia Repair: The PRICE Randomized Clinical Trial. Ann Surg. 2021 Apr 1;273(4):648-655. doi: 10.1097/SLA.0000000000004336.

  PMID: 33443907 RESULT

MeSH Terms

Conditions

Hernia, Ventral; Hernia; Surgical Wound; Recurrence; Infections

Condition Hierarchy (Ancestors)

Hernia, Abdominal; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Wounds and Injuries; Disease Attributes; Pathologic Processes

Results Point of Contact

• Title: Dr. Hobart W. Harris, Chief of General Surgery
• Organization: University of California, San Francisco

hobart.harris@ucsf.edu

(415) 514-3891

Study Officials

• Hobart W. Harris, M.D., M.P.H.

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor, Chief of General Surgery

Study Record Dates

• First Submitted: January 18, 2014
• First Posted: January 22, 2014
• Study Start: March 1, 2014
• Primary Completion: October 5, 2019
• Study Completion: October 5, 2019
• Last Updated: April 14, 2021
• Results First Posted: April 14, 2021

Record last verified: 2021-02

Locations

US (1)