Active Clinical Trials

Courtney Collins, MD Trials

Supporting At-Risk Patients (STAR) Program: Improving the Care of Disadvantaged Patients Undergoing Abdominal Hernia Repair through an Advanced Practitioner-Led Perioperative Outreach Program:

• Open to publicly insured patients to improve postoperative outcomes by providing additional contacts with a nurse practitioner. 
• PI: Courtney Collins, MD
• Contact: Savannah Renshaw, savannah.renshaw@osumc.edu

Jeffrey Janis, MD Trials

Prospective, Single-Blinded, Randomized-Controlled Trial Comparing The Performance Profiles of Two Non-Crosslinked Porcine Acellular Dermal Matrices in Abdominal Wall Reconstruction (Principal Investigator) Protocol# 2014H0041:

• Open to patients who are candidates for complex abdominal wall reconstruction using biologic mesh (as determined by the surgeon). Once enrolled, the choice of mesh will be randomly determined to be one of two FDA-approved biologic meshes. The purpose is to see if there is a difference between the two meshes.
• PI: Jeffrey Janis, MD
• Contact: 614-293-8566

Vascularized Composite Allotransplantation Program (Trunk). Protocol# – 2014H0414:

• Open to patients who are “end stage” abdominal wall disease (those who don’t have traditional options) who may require abdominal wall transplantation. Candidates will be screened in advance to determine whether they would meet strict inclusion criteria.
• PI: Jeffrey Janis, MD
• Contact: 614-293-8566

Prospective, randomized-controlled trial of sutured retrorectus polypropylene mesh versus ProGrip self-adhering mesh in abdominal wall reconstruction. Protocol # 2015H0442:

• Open to patients who are candidates for complex abdominal wall reconstruction using synthetic mesh (as determined by the surgeon). Once enrolled, the choice of mesh would be randomly determined to be one of two FDA-approved synthetic meshes. The purpose is to see if there is a difference between the two meshes.
• PI: Jeffrey Janis, MD
• Contact: 614-293-8566

The effect of preoperative subcutaneous heparin on the prevention of venous thromboembolism for patients undergoing abdominal wall reconstruction – a randomized controlled trial. Protocol # 2020H0427. (Principal Investigator):

• This study is open to all patients undergoing complex abdominal wall reconstruction. While all patients get low-dose blood thinners routinely to help prevent blood clots, the purpose is to determine whether administering low dose blood thinners before surgery (vs. after) makes any different in deep venous thrombosis (DVT) or pulmonary embolism (PE).
• PI: Jeffrey Janis, MD
• Contact: 614-293-8566

Vimal Narula, MD Trials

Parietene DS Composite Mesh in Ventral Hernia Repair Clinical Study:

• This study is a single arm, prospective, multi-center, observational, post-market study to confirm the clinical safety and performance of Parietene DS Composite Mesh in ventral hernia repair. 
• Enrollment is closed, and two-year follow-up of previously enrolled subjects is ongoing. 
• Study Sponsor – Medtronic/PI for OSU study site

A multi-center, randomized, controlled, single-blinded, parallel-group study evaluating the clinical performance and safety of LiquiBand FIX8 versus control for hernia mesh fixation and peritoneal closure in groin hernia repair:

• This investigational study is intended to evaluate the performance and safety of the LiquiBand FIX8 device for TEP or TAPP laparoscopic repair of groin hernias (femoral and inguinal) and closure of the peritoneum, compared to an existing marketed tack-based fixation device (AbsorbaTack). 
• Patients with a primary or recurrent groin hernia (unilateral or bilateral, inguinal or femoral) may be eligible to enroll. 
• Study Sponsor – Advanced Medical Solutions/PI for OSU study site

Benjamin Poulose, MD Trials

Abdominal core rehabilitation to improve outcomes after ventral hernia repair pilot trial

• The goal of this study is to test if supervised rehabilitation with a physical therapist helps patients get better faster after hernia surgery and reach a higher level of comfort and ability than with standard precautions.
• Study is open to patients undergoing ventral hernia repair.

Prospective Measures of Abdominal Core Function in Elective Ventral Hernia Patients:

• The goal of this study is to determine if repairing a ventral hernia has an impact on abdominal core function.
• Study is open to patients undergoing ventral hernia repair.

Evaluating Abdominal Core Health at the Mesh-Tissue Interface in Ventral Hernia Repair:

• The goal of this study is to determine what happens to mesh long-term after implantation in the human body.
• This is a collaborative study with one of our leading translational research scientists, Daniel Gallego-Perez, PhD, who is evaluating markers of inflammation and genetic profiles of cells that interact with mesh.
• Study is open to patients who are undergoing ventral hernia repair, especially those who have had mesh placed before and have had a hernia recurrence.

Prophylactic Reinforcement of Ventral Abdominal Incisions (PREVENT): Prospective, Multi-Center, Open-Label, Randomized, Controlled Trial of Phasix Mesh to Prevent Incisional Hernia Subsequent to Open Midline Laparotomy:

• The goal of this study is to determine if using a resorbable mesh at the time of abdominal surgery can reduce the risk of hernia formation long-term.
• Study is open to patients undergoing certain types of open abdominal surgery.
• Study Sponsor – BD Interventional

SeamlessMD: Improving Patient Navigation and Post-Operative Experience of Hernia Repair Using a Web-based Mobile Platform:

• The goal of this study is to determine if a phone app can be used as a guide to having elective surgery.
• Study is open to patients undergoing any type of abdominal wall hernia repair.

Toward Opioid Free Ambulatory Surgery (the TOFAS Study):

• The goal of this study is to evaluate if patients undergoing ambulatory surgery (being discharged on the same day of the surgery) can have pain managed without opioids.
• Patients undergoing hernia surgery who are discharged on the same day as their operation will be eligible to participate.

David Renton, MD Trials

TAP Blocks for Robotic Inguinal Hernia Repair:

• This study aims to determine if pain control injections performed at the time of robotic inguinal hernia repair improves pain control.
• Patients who are getting a robotic inguinal hernia repair can enroll.

Registry-Based, Prospective, Single-Blind, Randomized Controlled Trial: Intraperitoneal Onlay Mesh (IPOM) vs. Endoscopic Totally Extraperitoneal Repair of Ventral Hernias:

• Joint study with the Cleveland Clinic looking at post-op pain with two different approaches to mesh placement. 
• Patients undergoing primary ventral hernia repair can enroll.