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Procedure

Absorbable vs Non-absorbable Mesh for Umbilical Hernia Repair

N/A
Waitlist Available
Led By Todd Heniford, MD
Research Sponsored by Wake Forest University Health Sciences
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3-years postoperatively
Awards & highlights
No Placebo-Only Group

Summary

This trial will compare two types of mesh to fix an umbilical hernia, and check for recurrence, QoL, & problems after surgery over 3 yrs.

Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
Potential side effects may include discomfort at the surgery site, inflammation or infection, allergic reactions to materials used in meshes, chronic pain issues related to mesh presence or absorption process.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3-years postoperatively
This trial's timeline: 3 weeks for screening, Varies for treatment, and 3-years postoperatively for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Umbilical Hernia Recurrence
Secondary study objectives
Mesh Related Complication - Mesh excision
Mesh Related Complication - Mesh infection
Postoperative Outcome - 30-day readmission
+9 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

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.

Find a Location

Who is running the clinical trial?

Wake Forest University Health SciencesLead Sponsor
1,394 Previous Clinical Trials
2,459,616 Total Patients Enrolled
Todd Heniford, MDPrincipal InvestigatorWake Forest University Health Sciences
5 Previous Clinical Trials
688 Total Patients Enrolled

Media Library

Umbilical Hernia Repair (Procedure) Clinical Trial Eligibility Overview. Trial Name: NCT05994248 — N/A
Umbilical Hernia Research Study Groups: Absorbable Synthetic Mesh, Non-Absorbable Synthetic Mesh
Umbilical Hernia Clinical Trial 2023: Umbilical Hernia Repair Highlights & Side Effects. Trial Name: NCT05994248 — N/A
Umbilical Hernia Repair (Procedure) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05994248 — N/A
~280 spots leftby Jun 2029
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