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dHACM (AmnioWrap) for Incisional Hernia (NO-HERNIA Trial)
Phase 4
Waitlist Available
Research Sponsored by Louisiana State University Health Sciences Center in New Orleans
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 6 months
Awards & highlights
NO-HERNIA Trial Summary
This trial will compare the development of incisional hernias in patients who have dHACM added to their standard abdominal closure vs. those who only have a standard abdominal closure.
Eligible Conditions
- Incisional Hernia
NO-HERNIA Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 6 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Incidence of IH as determined by physical exam or abdominal ultrasound demonstrating a midline fascial defect and hernia sac> 4mm diameter
Secondary outcome measures
Intraoperative and postoperative complications
NO-HERNIA Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Treatment Arm-dHACMExperimental Treatment1 Intervention
Patients enrolled in this arm will have a thin sheet of dHACM placed as an overlay over the length of the closed incisions. dHACM is Dehydrated Human Amniotic-Chorion Membrane. It is a FDA registered healing adjunct that has been applied in a broad range of diseases including wounds, plantar fasciitis and burns.
Group II: Control ArmActive Control1 Intervention
Patients enrolled in this arm will have routine closure.
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Who is running the clinical trial?
LSUHSC-NOUNKNOWN
Louisiana State University Health Sciences Center in New OrleansLead Sponsor
115 Previous Clinical Trials
43,530 Total Patients Enrolled
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