An interventional study of Enform Mesh and Marlex in Umbilical Hernia, sponsored by Wake Forest University Health Sciences. Withdrawn. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-06-04.
Sponsored by Wake Forest University Health Sciences · Not applicable, Interventional, and Treatment
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.
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 of life (QOL) and postoperative complications in umbilical hernia repair. Patients will be randomized into one of two arms to receive an absorbable (Enform) mesh or non-absorbable (Marlex) mesh. Patients will undergo an umbilical hernia repair with the mesh assigned to their randomization cohort. The hernia recurrence, quality of life and postoperative outcomes to determine if the two meshes are non-inferior.
67 studies on the registry are indexed under Hernia, Umbilical; 13 are open to participants now.
Browse Hernia, Umbilical studies →Wake Forest University Health Sciences is the lead sponsor of 1,351 studies on the registry; 201 are open to participants now.
Of its 332 completed or terminated interventional studies of FDA-regulated products, 251 (76%) have results posted.
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Exclusion Criteria:
Subjects randomized to the non-absorbable synthetic mesh arm will undergo the procedure (umbilical hernia repair) to receive Marlex mesh.
Device: Marlex
Subjects randomized to the absorbable synthetic mesh arm will undergo the procedure (umbilical hernia repair) to receive Enform mesh.
Device: Enform Mesh
Use of absorbable mesh in umbilical hernia repair
Use of non-absorbable mesh in umbilical hernia repair
Umbilical Hernia Recurrence
The rate of hernia recurrence 3-years postoperatively
Time frame: 3-years postoperatively
Mesh Related Complication - Mesh infection
The rate of mesh infection within 1-year postoperatively
Time frame: 1-year postoperatively
Mesh Related Complication - Mesh excision
The rate of mesh excision within 1-year postoperatively
Time frame: 1-year postoperatively
Postoperative Outcome - 30-day readmission
The rate of 30-day readmission
Time frame: 30-days postoperatively
Postoperative Outcome - Seroma
The rate seroma within 3-years postoperatively
Time frame: 3-years postoperatively
Postoperative Outcome - Hematoma
The rate of hematoma within 3-years postoperatively
Time frame: 3-years postoperatively
Postoperative Outcomes - Intra-abdominal abscess
The rate of intra-abdominal abscess within 3-years postoperatively
Time frame: 3-years postoperatively
Postoperative Outcome - Wound cellulitis
The rate of wound cellulitis within 3-years postoperatively
Time frame: 3-years postoperatively
Postoperative Outcome - Wound infection
The rate of wound infection within 3-years postoperatively
Time frame: 3-years postoperatively
Postoperative Outcome - Superficial wound breakdown
The rate of superficial wound breakdown within 3-years postoperatively
Time frame: 3-years postoperatively
Postoperative Outcomes - Mortality
The rate of mortality within 3-years postoperatively
Time frame: 3-years postoperatively
Postoperative Outcomes - Length of stay
The length of stay (LOS) in the hospital postoperatively
Time frame: 3-years postoperatively
Quality of Life (QOL)
QOL within 3-years of surgery as measured by the Carolinas Comfort Scale (CCS), a validated hernia specific QOL questionnaire. The CCS has 23 questions across 3 domains (mesh sensation, pain, and movement) that are scored 0-5 and N/A. Higher scores indicate worse symptoms. A score of 2 or more in any category is considered "symptomatic"; a score of 0 or 1 is considered "asymptomatic". Data will be reported as the frequency and percentage of "symptomatic" or "asymptomatic" for each of the 3 domains.
Time frame: 3-years postoperatively
No study locations are listed for this record.
Plan to share: No — IPD will not be made available to other researchers.
No publications or documents are linked to this record.
This study is withdrawn, as verified in May 2024. You cannot join it, but the record below documents what was studied.
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