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Absorbable vs Non-absorbable Mesh for Umbilical Hernia Repair

TH
GS
Overseen ByGreg Scarola, MS
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Wake Forest University Health Sciences
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

The goal of this study is to see which of two types of mesh is better for fixing an umbilical hernia. One type of mesh is an absorbable synthetic mesh, which goes away on its own in the body, and the other type of mesh is a non-absorbable mesh, which stays in the body forever. The researchers will check if the hernia comes back, how it affects the patient's quality of life, and if there are any problems after the surgery during a three-year period.

Who Is on the Research Team?

TH

Todd Heniford, MD

Principal Investigator

Wake Forest University Health Sciences

Are You a Good Fit for This Trial?

This trial is for adults over 18 with a primary umbilical hernia, which is a gap in the abdominal wall near the belly button. The hernia should be sized between 1-4cm2 and suitable for elective laparoscopic or open repair. Only those with CDC class 1 & 2 wounds, indicating lower infection risk, can join.

Inclusion Criteria

My wound is either clean or has minor infection.
I am scheduled for a planned minimally invasive or open surgery.
My injury or defect is between 1 and 4 square centimeters in size.
See 1 more

Exclusion Criteria

Not applicable.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo umbilical hernia repair with either absorbable or non-absorbable mesh

1 week
1 visit (in-person)

Follow-up

Participants are monitored for hernia recurrence, quality of life, and postoperative complications

3 years
Regular follow-up visits over 3 years

What Are the Treatments Tested in This Trial?

Interventions

  • Umbilical Hernia Repair
Trial Overview The study compares two types of surgical mesh used in umbilical hernia repairs: Enform Mesh (absorbable synthetic) that dissolves over time and Marlex (non-absorbable synthetic) that remains permanently. It aims to determine their effectiveness and impact on quality of life over three years.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Active Control
Group I: Non-Absorbable Synthetic MeshExperimental Treatment1 Intervention
Group II: Absorbable Synthetic MeshActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Wake Forest University Health Sciences

Lead Sponsor

Trials
1,432
Recruited
2,506,000+
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