Observational Biologic or Prosthetic Mesh

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

28 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-02-11

Study Completion Date

2021-06-11

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Ventral Incisional Hernia

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Standard of care

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

Mesh for hernia repair

Intervention Type DEVICE

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

Interventions

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Mesh for hernia repair

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

Intervention Type DEVICE

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No