BridgeMD
New treatment option for Open Midline Laparotomy
Official title Prophylactic Reinforcement of Ventral Abdominal Incisions Trial
ClinicalTrials.gov ID: NCT03911700
What this study is testing
- What it's testing
- This trial is being conducted to evaluate the efficacy of Phasix™ Mesh implantation at the time of midline fascial closure compared to primary suture closure in preventing a subsequent incisional hernia in subjects at risk for incisional hernia after open midline laparotomy surgery.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Must be ≥ 18 years of age
- Elective, open midline laparotomy ≥ 5 cm
- Willing and able to provide written informed consent
- Hernia risk equal to moderate or greater
You likely can't join if
- Previous hernia repair
- Emergent surgery
- Creation of skin flaps is preplanned
- Preplanned 2nd surgery
- Active skin pathology
- Life expectancy less than 24 months
See the full eligibility criteria
- Must be ≥ 18 years of age
- Elective, open midline laparotomy ≥ 5 cm
- Willing and able to provide written informed consent
- Hernia risk equal to moderate or greater
- Previous hernia repair
- Emergent surgery
- Creation of skin flaps is preplanned
- Preplanned 2nd surgery
- Active skin pathology
- Life expectancy less than 24 months
- Pregnant or planning to become pregnant
- Receiving a medication/medical condition that may adversely affect wound healing
- ASA Class \> IV
- Enrolled in another clinical trial
- Site personnel directly involved with this trial
- Any condition that would preclude the use of the device or the subject form completing the follow-up requirements
- Known or suspected allergy to tetracycline hydrochloride or kanamycin sulfate
- Two separate incisions are created
- Prior onlay mesh
- Surgeon is unable to fully close the fascia
- The surgery requires more than a single piece of mesh
- Contraindication to placement of mesh
- CDC Class IV/Active Infection
- Breastfeeding
The study team makes the final eligibility decision.
Where it's taking place
- Phoenix, Arizona, United States
- Los Angeles, California, United States
- San Francisco, California, United States
- Hartford, Connecticut, United States
- Atlanta, Georgia, United States
- Peoria, Illinois, United States
- Indianapolis, Indiana, United States
- Lexington, Kentucky, United States
- New Orleans, Louisiana, United States
- Boston, Massachusetts, United States
- Ann Arbor, Michigan, United States
- Minneapolis, Minnesota, United States
- Kansas City, Missouri, United States
- Springfield, Missouri, United States
- St Louis, Missouri, United States
- Omaha, Nebraska, United States
- New Brunswick, New Jersey, United States
- New York, New York, United States
- The Bronx, New York, United States
- Charlotte, North Carolina, United States
+ 20 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Phoenix, Arizona, United States; Los Angeles, California, United States; San Francisco, California, United States; Hartford, Connecticut, United States; Atlanta, Georgia, United States; Peoria, Illinois, United States and 34 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.