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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
17
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.
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.
Tampa General Hospital
Tampa, Florida, United States
University of South Florida - South Tampa Campus
Tampa, Florida, United States
University of South Florida Morsani Center for Advanced Health Care
Tampa, Florida, United States
Incidence of incisional hernia recurrence
Time frame: 2 years from study incisional hernia repair
Time to incisional hernia recurrence
Time frame: 2 years from study incisional hernia repair
Incidence of wound complications
Complications of interest: surgical site infections, seroma formation, and wound dehiscence or skin separation
Time frame: 90 days from study incisional hernia repair
Incidence of enterocutaneous fistula formation
Time frame: 2 years from study incisional hernia repair
Mean Carolinas Comfort Scale score
Patient-centered outcome
Time frame: 2 years from study incisional hernia repair
Mean Visual Analog Scale score
Patient-centered outcome
Time frame: 2 years from study incisional hernia repair
Mean mesh deployment time
Defined as the time mesh preparation starts to time mesh placement ends
Time frame: duration of surgery (incisional hernia repair)
Mean procedure time
Defined as time of incision to time of closure
Time frame: duration of surgery (incisional hernia repair)
Mean total cost of hospitalization for primary admission
Defined as from surgery to hospital discharge
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Time frame: duration of hospitalization for incisional hernia repair
Mean total cost of surgery for primary admission
Defined as from preoperative preparation to anesthesia discharge
Time frame: duration of surgery (incisional hernia repair)
Mean total cost of narcotic usage for primary admission
Defined as narcotic use from surgery to hospital discharge
Time frame: duration of hospitalization for incisional hernia repair
Mean total cost of readmissions
Defined as any hospital readmissions related to ventral hernia complications or recurrence
Time frame: 2 years from study incisional hernia repair