RecruitingNAINTERVENTIONAL

Prophylactic Reinforcement of Ventral Abdominal Incisions Trial

This study is for people having a specific type of tummy (abdominal) surgery where a cut is made down the middle of the stomach. We want to see if placing a special mesh, called Phasix™ Mesh, during the first operation can help prevent a common problem called an incisional hernia. An incisional hernia is when part of your insides pushes through the weak spot where the cut was made. Currently, doctors just stitch the opening closed. This study will compare people who get the mesh with those who just have the standard stitching. The aim is to find out if the mesh makes it less likely for a hernia to form in the future, meaning fewer possible operations down the line.

At a glance

Status

Recruiting

Phase

Sponsor

C. R. Bard

Enrolment target

477

Start

12 Dec 2019

Estimated completion

01 Dec 2031

Open Midline Laparotomy

What is this study about?

When you have an operation on your tummy, especially one where the surgeon makes a cut down the middle, there's a chance that the wound might not heal perfectly strongly. Sometimes, years later, a weakness can develop, and fatty tissue or even part of your bowel can push through this weak spot, creating a bulge under your skin. This is called an incisional hernia, and it often needs another operation to fix.

This study is looking at a new way to try and prevent these hernias from happening in the first place. For people having an open tummy operation, surgeons usually stitch the layers of muscle and tissue back together. This study wants to see if adding a special mesh, called Phasix™ Mesh, behind these stitches at the time of your first surgery could give extra support and make the area stronger.

By adding this mesh, we hope to reduce the chances of you developing an incisional hernia later on. We are comparing this new approach with the standard way of just stitching the wound closed. This will help us understand if the mesh is a helpful new step to make your recovery stronger and reduce the need for future operations.

Key takeaways

A study to prevent hernias after tummy surgery.
Compares a special mesh with standard stitches.
For people having planned open tummy surgery.
Could reduce the need for future hernia operations.
Participation involves being randomly assigned to a group.
You can stop participating at any time.

Who may be eligible?

To be part of this study, you need to be at least 18 years old and be having a specific type of elective open tummy operation where the cut is at least 5 centimetres long in the middle of your stomach. You also need to be at a moderate or higher risk of getting a hernia after your surgery.

There are some reasons why you wouldn't be able to join. For example, if you've already had a hernia repaired before, or if your surgery is an emergency rather than planned. Also, if you're pregnant, breastfeeding, or planning to become pregnant, you can't take part. We also can't include you if you have certain health conditions that might affect how your wound heals or how you react to the mesh, or if you're already in another medical study.

Your surgeon will also need to be able to fully close the muscle layers during your operation, and there shouldn't be any active infection or other reasons why putting a mesh in would be unsuitable for you.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you at least 18 years old?
Are you having a planned open tummy operation where the cut will be down the middle?
Have you *not* had a hernia repaired before?
Are you *not* pregnant, breastfeeding, or planning to be pregnant soon?
Do you *not* have any active infections or serious skin problems?
Are you *not* currently in another medical research study?

Answer every question to see your result.

What does participation involve?

If you decide to take part, when you're in the operating room after your main surgery, you'll be randomly chosen to either receive the special mesh in addition to your stitches, or just have the standard stitches. Like tossing a coin, there's an equal chance of being in either group. We don't specify the exact number of follow-up visits or the total length of the study here, but you would be regularly checked by your doctors after your operation to see how you are recovering and to monitor for any hernia development.

Potential risks and benefits

The potential benefit of taking part is that if you receive the mesh, it might reduce your chance of developing an incisional hernia later on, potentially avoiding another surgery. However, adding a mesh could have its own risks, such as infection or issues related to the mesh itself, although these would be thoroughly discussed with you by your medical team. You also have the right to withdraw from the study at any time without affecting your medical care.

Locations (44)

Dignity Health
Verified postcode
Phoenix, United States· Recruiting
Keck Medical Center of USC
Verified postcode
Los Angeles, United States· Withdrawn
University of California San Francisco
Verified postcode
San Francisco, United States· Recruiting
Hartford Hospital
Verified postcode
Hartford, United States· Active not recruiting
St. Francis Hospital and Medical Center
Verified postcode
Hartford, United States· Withdrawn
Emory University
Verified postcode
Atlanta, United States· Terminated
OSF Saint Francis Medical Center
Verified postcode
Peoria, United States· Active not recruiting
Indiana University
Verified postcode
Indianapolis, United States· Active not recruiting
University of Kentucky Research Foundation
Verified postcode
Lexington, United States· Recruiting
Tulane University School of Medicine
Verified postcode
New Orleans, United States· Recruiting
University of Michigan
Verified postcode
Ann Arbor, United States· Withdrawn
Minneapolis VA Health Care System
Verified postcode
Minneapolis, United States· Withdrawn

Common questions

What is an incisional hernia?

It's a bulge that can appear near a surgical scar, usually on your tummy, caused by weakened muscle and tissue allowing something to push through.

What is the Phasix™ Mesh?

It's a special material, like a support patch, that surgeons might use to strengthen the area where your tummy muscles are stitched after surgery.

Will I know if I get the mesh?

After your surgery, you will be told whether you received the mesh or had the standard stitch closure.

Does taking part affect my normal treatment?

No, your planned surgery will still happen as normal. This study adds a step to your surgery or compares it to the usual method.

How long will I be followed up for?

The information provided does not specify the exact duration, but you would have regular check-ups to monitor your recovery.

How to find out more

Amanda Resendes, MBA

amanda.resendes@bd.com 401-209-7141 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.