Absorbable vs Non-absorbable Mesh for Umbilical Hernia Repair

Palo Alto (17 mi)

Overseen byTodd Heniford, MD

Age: 18+

Sex: Any

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: N/A

Waitlist Available

Sponsor: Wake Forest University Health Sciences

No Placebo Group

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.

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.

Treatment Details

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.

2Treatment groups

Experimental Treatment

Active Control

Group I: Non-Absorbable Synthetic MeshExperimental Treatment1 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 MeshActive Control1 Intervention

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