Umbilical HerniaNCT05994248
Randomized Controlled Trial (RCT) Umbilical Hernia Repair (UHR) Absorbable vs Non-absorbable Synthetic Mesh
A study testing Enform Mesh and Marlex in people with Umbilical Hernia, run by Wake Forest University Health Sciences.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Umbilical Hernia
- What is being tested?
- Enform Mesh and Marlex
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Mar 2025to Jun 2029
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- None
About this study
Official title: Absorbable and Synthetic Mesh: A Multicenter, Prospective, Non-Inferior, Randomized Controlled 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.
Read the detailed description
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.
- Conditions
- Umbilical Hernia
- Being tested
- Enform Mesh, Marlex
- Keywords
- Randomized Controlled Trial (RCT), Absorbable Mesh, Non-Absorbable Mesh
- Medical subject headings
- Hernia, Umbilical
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Enform MeshDevice
Use of absorbable mesh in umbilical hernia repair
MarlexDevice
Use of non-absorbable mesh in umbilical hernia repair
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: Enform Mesh |
What is being measured
The primary outcome is the main question the study is designed to answer.
Umbilical Hernia Recurrence
The rate of hernia recurrence 3-years postoperatively
Measured: 3-years postoperatively
Secondary outcomes (12)
Mesh Related Complication - Mesh infection
The rate of mesh infection within 1-year postoperatively
Measured: 1-year postoperatively
Mesh Related Complication - Mesh excision
The rate of mesh excision within 1-year postoperatively
Measured: 1-year postoperatively
Postoperative Outcome - 30-day readmission
The rate of 30-day readmission
Measured: 30-days postoperatively
Postoperative Outcome - Seroma
The rate seroma within 3-years postoperatively
Measured: 3-years postoperatively
Postoperative Outcome - Hematoma
The rate of hematoma within 3-years postoperatively
Measured: 3-years postoperatively
Postoperative Outcomes - Intra-abdominal abscess
The rate of intra-abdominal abscess within 3-years postoperatively
Measured: 3-years postoperatively
Postoperative Outcome - Wound cellulitis
The rate of wound cellulitis within 3-years postoperatively
Measured: 3-years postoperatively
Postoperative Outcome - Wound infection
The rate of wound infection within 3-years postoperatively
Measured: 3-years postoperatively
Postoperative Outcome - Superficial wound breakdown
The rate of superficial wound breakdown within 3-years postoperatively
Measured: 3-years postoperatively
Postoperative Outcomes - Mortality
The rate of mortality within 3-years postoperatively
Measured: 3-years postoperatively
Postoperative Outcomes - Length of stay
The length of stay (LOS) in the hospital postoperatively
Measured: 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.
Measured: 3-years postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2023
- Study startMar 2025 (estimated)
- Primary completionJun 2029 (estimated)
- Study completionJun 2029 (estimated)
Why it stopped: study was never opened and PI now leaving institution
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Umbilical HerniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Todd Heniford, MD, Principal investigator, Wake Forest University Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05994248
- Sponsor's protocol ID
- IRB00097688
- Status last verified
- May 2024
- First submitted
- 8 Aug 2023
- Last updated
- 4 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: IPD will not be made available to other researchers.
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Absorbable and Synthetic Mesh: A Multicenter, Prospective, Non-Inferior, Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05994248
- Acronym / sponsor ID
- IRB00097688
- Conditions
- Umbilical Hernia
- Keywords
- Randomized Controlled Trial (RCT), Absorbable Mesh, Non-Absorbable Mesh
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: study was never opened and PI now leaving institution
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Study start
- Mar 2025 (estimated)
- Primary completion
- Jun 2029 (estimated)
- Study completion
- Jun 2029 (estimated)
- First posted
- 16 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Non-Absorbable Synthetic Mesh | Experimental | Device: MarlexSubjects randomized to the non-absorbable synthetic mesh arm will undergo the procedure (umbilical hernia repair) to receive Marlex mesh. |
| Absorbable Synthetic Mesh | Active comparator | Device: Enform MeshSubjects randomized to the absorbable synthetic mesh arm will undergo the procedure (umbilical hernia repair) to receive Enform mesh. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Enform MeshUse of absorbable mesh in umbilical hernia repair | Device | Absorbable Synthetic Mesh |
| MarlexUse of non-absorbable mesh in umbilical hernia repair | Device | Non-Absorbable Synthetic Mesh |
Primary outcome
Umbilical Hernia Recurrence
Time frame: 3-years postoperatively
The rate of hernia recurrence 3-years postoperatively
12 secondary outcomes
Mesh Related Complication - Mesh infection
Time frame: 1-year postoperatively
Mesh Related Complication - Mesh excision
Time frame: 1-year postoperatively
Postoperative Outcome - 30-day readmission
Time frame: 30-days postoperatively
Postoperative Outcome - Seroma
Time frame: 3-years postoperatively
Postoperative Outcome - Hematoma
Time frame: 3-years postoperatively
Postoperative Outcomes - Intra-abdominal abscess
Time frame: 3-years postoperatively
Postoperative Outcome - Wound cellulitis
Time frame: 3-years postoperatively
Postoperative Outcome - Wound infection
Time frame: 3-years postoperatively
Postoperative Outcome - Superficial wound breakdown
Time frame: 3-years postoperatively
Postoperative Outcomes - Mortality
Time frame: 3-years postoperatively
Postoperative Outcomes - Length of stay
Time frame: 3-years postoperatively
Quality of Life (QOL)
Time frame: 3-years postoperatively
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2025.
- Individual participant dataSharing planned: No. IPD will not be made available to other researchers.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Todd Heniford, MD principal investigator
Wake Forest University Health Sciences
Questions about this trial
What is this clinical trial studying?
A study testing Enform Mesh and Marlex in people with Umbilical Hernia, run by Wake Forest University Health Sciences.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 4 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Umbilical Hernia Recurrence (time frame: 3-years postoperatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jun 2025.