Observational Biologic or Prosthetic Mesh

Terminated

• Conditions: Ventral Incisional Hernia
• Interventions: Device: Mesh for hernia repair

• Registration Number: NCT03317665
• Lead Sponsor: University of South Florida

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study First Submitted: 2017-10-10
• Study First Submitted QC: 2017-10-20
• Study First Posted: 2017-10-23
• Study Start: 2019-02-11
• Primary Completion: 2021-06-11
• Study Completion: 2021-06-11
• Status Verified: 2021-09
• Last Update Submitted: 2021-09-28
• Last Update Posted: 2021-10-06

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 28

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Incidence of ventral hernia recurrence	2 years from study ventral hernia repair

Secondary Outcome Measures

Name	Time	Method
Mean total cost of hospitalization for primary admission	From date of surgery to date of hospital discharge (approximately 3 days)	Defined as cost from surgery to hospital discharge
Mean total cost of surgery for primary admission	during surgery	Defined as cost from preoperative preparation to anesthesia discharge
Time to ventral hernia recurrence	2 years from study ventral hernia repair
Incidence of enterocutaneous fistula formation	2 years from study ventral hernia repair
Mean Carolinas Comfort Scale score	2 years from study ventral hernia repair	Patient-centered outcome assessing hernia symptoms - minimum score 0 and maximum total score 115
Mean procedure time	during surgery	Defined as time of incision to time of closure
Mean mesh deployment time	during surgery	Defined as the time mesh preparation starts to time mesh placement ends
Mean total cost of narcotic usage for primary admission	From date of surgery to date of hospital discharge (approximately 3 days)	Defined as cost from narcotic use from surgery to hospital discharge
Incidence of wound complications	90 days from study ventral hernia repair	Complications of interest: surgical site infections, seroma formation, and wound dehiscence or skin separation
Mean Visual Analog Scale score	2 years from study ventral hernia repair	Patient-centered outcome - pain score measured by a line in millimeters (0 for no pain and 10 for worst pain imaginable)
Mean total cost of readmissions	2 years from study ventral hernia repair	any hospital readmissions related to ventral hernia complications or recurrence

Trial Locations

Locations (3)

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