A Prospective, Double-Blinded, Randomized Controlled Trial of dHACM for Incisional Hernia Prophylaxis

Status unconfirmed · Phase 4

Conditions studied: Incisional Hernia

In brief

Currently, no standard of care exists to prevent incisional hernias (IH). This study will compare how frequently IH develop in standard abdominal closures vs. abdominal closures with dHACM added. By adding dHACM to the standard closure, we think we can reduce the formation of IH. If patients decide to participate in this study, they will be randomly assigned to one of two study arms, Arm A or Arm B. They will have a 50% chance of being assigned to either arm. The assignment will be made by computer program and is completely random. Patients are not informed of which arm they are assigned. Arm A (Treatment Arm): dHACM 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. Arm B (Control Arm) Patients enrolled in this arm will have standard fascial closure. Data collection will be performed at routine follow-up outpatient clinic visits with the primary surgeon to assess for IH related symptoms. At 6 months after surgery, patients will see a surgeon who is blinded to the randomization. This surgeon will perform a painless handheld ultrasound examination of the incision site.

Key facts

Study ID

NCT04417140

Run by

Louisiana State University Health Sciences Center in New Orleans

People needed

533

Starts

2020-05-20

Expected to finish

2022-05-20

Last updated by the study team

2020-06-04

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Patient > 18 years
• Written informed consent
• Non-emergent operation
• Predicted incisional herna (IH) risk ≥150% of the average IH risk, as calculated by the University of Pennsylvania Hernia Risk Calculator, which accounts for 18 IH risk factors
• BMI > 27 yields IH risk > 150% of the average IH risk; this can be used as a shortcut for screening potential subjects

You may not qualify if…

• Previous intraperitoneal mesh placement
• Previous abdominal incisional hernia
• Emergency procedures
• Patients with inflammatory bowel disease

Where it is running

• University Medical Center — New Orleans, Louisiana, United States (enrolling)

Full record on ClinicalTrials.gov

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