Randomized Controlled Trial (RCT) Umbilical Hernia Repair (UHR) Absorbable vs Non-absorbable Synthetic Mesh

NCT05994248 | Withdrawn FDA Device

• 1 other identifier: IRB00097688
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Umbilical Hernia

Keywords

Randomized Controlled Trial (RCT); Absorbable Mesh; Non-Absorbable Mesh

Outcome Measures

Primary Outcomes (1)

• Umbilical Hernia Recurrence

  The rate of hernia recurrence 3-years postoperatively

  3-years postoperatively

Secondary Outcomes (12)

• Mesh Related Complication - Mesh infection

  1-year postoperatively

• Mesh Related Complication - Mesh excision

  1-year postoperatively

• Postoperative Outcome - 30-day readmission

  30-days postoperatively

• Postoperative Outcome - Seroma

  3-years postoperatively

• Postoperative Outcome - Hematoma

  3-years postoperatively

Study Arms (2)

Non-Absorbable Synthetic Mesh

EXPERIMENTAL

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

Device: Marlex

Absorbable Synthetic Mesh

ACTIVE COMPARATOR

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

Device: Enform Mesh

Interventions

Enform Mesh DEVICE

Use of absorbable mesh in umbilical hernia repair

Absorbable Synthetic Mesh

Marlex DEVICE

Use of non-absorbable mesh in umbilical hernia repair

Non-Absorbable Synthetic Mesh

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18 years and older
• Primary umbilical hernia repair (UHR) \[as defined by European Hernia Society (EHS) guidelines primary midline abdominal wall defect from 3 cm above to 3 cm below the umbilicus\]
• Undergoing elective laparoscopic or open repair
• Defect size of 1-4cm2
• Centers for Disease Control and Prevention (CDC) class 1 \& 2 wounds

You may not qualify if:

• None

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead

MeSH Terms

Conditions

Hernia, Umbilical

Condition Hierarchy (Ancestors)

Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Hernia, Ventral; Hernia, Abdominal; Hernia; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Todd Heniford, MD

  Wake Forest University Health Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 8, 2023
• First Posted: August 16, 2023
• Study Start: March 1, 2025
• Primary Completion (Estimated): June 1, 2029
• Study Completion (Estimated): June 1, 2029
• Last Updated: June 4, 2025

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share