Gentrix™ Versus Biological or Prosthetic Mesh

Ventral Incisional Hernia Clinical Trial

Official title:

Randomized, Controlled Trial Comparing Separation of Components Repair With Retrorectus Gentrix™ Surgical Matrix Versus Biological or Prosthetic Mesh for Open Ventral Hernia Repair

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03034213
• Other study ID #: CA2017-002
• Status: Terminated
• Phase: N/A
• Start date: October 6, 2017
• Est. completion date: June 16, 2021

Study information

• Verified date: September 2021
• Source: University of South Florida
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 17
• Est. completion date: June 16, 2021
• Est. primary completion date: June 16, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Hernia
• Incisional Hernia
• Ventral Incisional Hernia

Intervention

Device:
• 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.
• 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.

Locations

Country	Name	City	State
United States	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

Sponsors (2)

Lead Sponsor	Collaborator
University of South Florida	Integra LifeSciences Corporation

Country where clinical trial is conducted

United States, 

References & Publications (8)

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. — View Citation

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. Ep — View Citation

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. Review. — View Citation

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. — View Citation

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 — View Citation

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;1 — View Citation

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. — View Citation

Zhou XH, Melfi CA, Hui SL. Methods for comparison of cost data. Ann Intern Med. 1997 Oct 15;127(8 Pt 2):752-6. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of incisional hernia recurrence		2 years from study incisional hernia repair
Secondary	Time to incisional hernia recurrence		2 years from study incisional hernia repair
Secondary	Incidence of wound complications	Complications of interest: surgical site infections, seroma formation, and wound dehiscence or skin separation	90 days from study incisional hernia repair
Secondary	Incidence of enterocutaneous fistula formation		2 years from study incisional hernia repair
Secondary	Mean Carolinas Comfort Scale score	Patient-centered outcome	2 years from study incisional hernia repair
Secondary	Mean Visual Analog Scale score	Patient-centered outcome	2 years from study incisional hernia repair
Secondary	Mean mesh deployment time	Defined as the time mesh preparation starts to time mesh placement ends	duration of surgery (incisional hernia repair)
Secondary	Mean procedure time	Defined as time of incision to time of closure	duration of surgery (incisional hernia repair)
Secondary	Mean total cost of hospitalization for primary admission	Defined as from surgery to hospital discharge	duration of hospitalization for incisional hernia repair
Secondary	Mean total cost of surgery for primary admission	Defined as from preoperative preparation to anesthesia discharge	duration of surgery (incisional hernia repair)
Secondary	Mean total cost of narcotic usage for primary admission	Defined as narcotic use from surgery to hospital discharge	duration of hospitalization for incisional hernia repair
Secondary	Mean total cost of readmissions	Defined as any hospital readmissions related to ventral hernia complications or recurrence	2 years from study incisional hernia repair