Absorbable vs Non-absorbable Mesh for Umbilical Hernia Repair

Overseen By Greg Scarola, MS

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Wake Forest University Health Sciences

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 4

Duration: 1 week

Trial Summary

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.

Research Team

Todd Heniford, MD

Principal Investigator

Wake Forest University Health Sciences

Eligibility Criteria

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 18 years old or older.

I am scheduled for a planned minimally invasive or open surgery.

Exclusion Criteria

Not applicable.

Timeline

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

Treatment Details

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.

Participant Groups

Group I: Non-Absorbable Synthetic Mesh Experimental Treatment 1 Intervention

Subjects randomized to the non-absorbable synthetic mesh arm will undergo the procedure (umbilical hernia repair) to receive Marlex mesh.

Group II: Absorbable Synthetic Mesh Active Control 1 Intervention

Subjects randomized to the absorbable synthetic mesh arm will undergo the procedure (umbilical hernia repair) to receive Enform mesh.

Who Is Running the Clinical Trial?

Wake Forest University Health Sciences

Lead Sponsor

Trials

1,432

Recruited

2,506,000+