Gentrix™ Versus Biological 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

Clinical Phase

NA

Total Enrollment

17 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-10-06

Study Completion Date

2021-06-16

Brief Summary

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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.

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Detailed Description

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Biological and prosthetic mesh products are extensively used in hernia repairs. However, they also have their limitations. 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. This study is a two-arm, randomized, controlled trial comparing separation of components repair with retrorectus Gentrix™ Surgical Matrix versus biological or prosthetic mesh for open ventral hernia repair.

Conditions

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Ventral Incisional Hernia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Treatment

Gentrix(TM) Surgical Matrix

Group Type ACTIVE_COMPARATOR

Gentrix™ Surgical Matrix (Treatment)

Intervention Type 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.

Control

Standard of care mesh

Group Type ACTIVE_COMPARATOR

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

Intervention Type 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.

Interventions

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Gentrix™ Surgical Matrix (Treatment)

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.

Intervention Type DEVICE

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

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.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* 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.

Exclusion Criteria

* 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.
* Suspected presence of enterocutaneous fistula.
* Planned use of external VAC dressing intra-operatively.
* Suspected bowel obstruction (partial or intermittent), strangulation, peritonitis, or perforation.
* Active necrotizing fasciitis or any other known active local or systemic infection.
* Subject report of participation in an investigational drug or device study that would impact the safety or scientific integrity of this study (in the opinion of the Investigator and with the approval of the Sponsor) within the past 6 weeks prior to treatment in this trial.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No