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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine which type of mesh better repairs an umbilical hernia, a condition where part of the intestine pushes through the belly button area. One mesh type dissolves in the body over time, while the other remains permanently. Researchers will examine whether the hernia recurs, how the mesh affects daily life, and any surgery-related issues over three years. This trial suits individuals with a small umbilical hernia who plan to have it surgically repaired. As an unphased trial, it offers a unique opportunity to contribute to understanding the best surgical options for hernia repair.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that both absorbable and non-absorbable synthetic meshes are generally safe for hernia repairs, with some differences.

Absorbable synthetic mesh is designed to dissolve over time. Studies have found it to be well-tolerated and not more problematic in the short term compared to permanent mesh. However, its dissolving nature may not provide long-lasting support.

Non-absorbable synthetic mesh remains in the body. Research indicates it has a low risk of infection and offers long-term support, helping to prevent hernia recurrence.

In summary, both types of mesh are safe according to studies, but they serve different purposes. Absorbable mesh is temporary, while non-absorbable mesh provides permanent support. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these treatments for umbilical hernia repair because they are exploring different types of synthetic mesh. The absorbable synthetic mesh, Enform, is designed to gradually break down in the body, potentially reducing long-term complications and the need for future surgeries. On the other hand, the non-absorbable synthetic mesh, Marlex, remains in the body, providing durable support over time. This trial aims to compare these two approaches to determine which offers better outcomes and fewer side effects for patients.

What evidence suggests that this trial's mesh treatments could be effective for umbilical hernia repair?

This trial will compare absorbable synthetic mesh with non-absorbable synthetic mesh for umbilical hernia repair. Research has shown that using mesh for umbilical hernia repair reduces the chance of recurrence compared to stitching alone. Participants may receive absorbable synthetic mesh, which gradually dissolves and shows similar complication rates and outcomes in the first year as permanent mesh. Alternatively, participants may receive non-absorbable mesh, which remains in the body, providing lasting results with fewer hernia recurrences, though it may cause more long-term pain than absorbable mesh. Both types of mesh are effective, but they differ in duration within the body and side effects. ^{4 5 6 7 8}

Who Is on the Research Team?

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.

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?

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+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7260408/

Mesh versus suture in elective repair of umbilical hernia The use of mesh in elective repair of umbilical hernia reduced the risk of recurrence compared with suture closure without altering the risk of chronic pain.

2. sciencedirect.com sciencedirect.com/science/article/pii/S2666138120300025

Hernia Mesh and Hernia Repair: A Review Absorbable sutures are known to lose their strength too fast, therefore causing more hernia reoccurrences. Nonabsorbable sutures are can retain their strength ...

3. frontierspartnerships.org frontierspartnerships.org/journals/journal-of-abdominal-wall-surgery/articles/10.3389/jaws.2025.14836/full

Inguinal Hernia Repair Using Absorbable Biosynthetic Mesh ... Complications and 1-year outcomes following inguinal hernia repair are not statistically different between absorbable biosynthetic and permanent synthetic mesh.

4. jamanetwork.com jamanetwork.com/journals/jamasurgery/fullarticle/2788222

Biologic vs Synthetic Mesh for Single-stage Repair of ... Compared with biologic mesh, synthetic mesh significantly reduced the risk of hernia recurrence (hazard ratio, 0.31; 95% CI, 0.23-0.42; P < .001) ...

5. clinicaltrials.gov clinicaltrials.gov/study/NCT05994248?term=AREA%5BConditionSearch%5D(Navel)%20AND%20AREA%5BLastUpdatePostDate%5D%20RANGE%5B2020-02-18,MAX%5D&rank=5

Randomized Controlled Trial (RCT) Umbilical Hernia ... The goal of this study is to compare the use of absorbable synthetic (AS) mesh versus non-absorbable mesh (NAS) mesh to determine the 3-year recurrence, quality ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10672379/

A Review of Abdominal Meshes for Hernia Repair—Current ... Synthetic meshes are inadequate for hernia repairs involving an open abdomen or in contaminated/infected fields because of their increased risks of adhesions, ...

7. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1091255X23018917

Safety and Long-Term Outcomes After Hernia Repairs with ... Four studies compared mesh repair technique with synthetic mesh or other type of meshes were included. The incidence of SSI was significantly lower in the ...

8. fda.gov fda.gov/medical-devices/implants-and-prosthetics/surgical-mesh-used-hernia-repair

Surgical Mesh Used for Hernia Repair Absorbable mesh will be absorbed and lose strength over time. It is not intended to provide long-term reinforcement to the repair site. As the ...