A Prospective, Double-Blinded, Randomized Controlled Trial of dHACM for Incisional Hernia Prophylaxis (NO-HERNIA)

A Prospective, Double-Blinded, Randomized Controlled Trial of Dehydrated Human Amniotic-Chorionic Membrane for Incisional Hernia Prophylaxis

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.

Study Overview

• Status: Unknown
• Conditions: Incisional Hernia
• Intervention / Treatment: Biological: dHACM (AmnioWrap)

Detailed Description

Two million laparotomies are performed annually in the United States (US). Following these surgeries, the incidence of new incisional hernias (IH) is estimated at 400,000 cases per year. These hernias are a major source of morbidity and mortality for patients, and they result in $6-10 billion per year in healthcare costs. Our multidisciplinary hernia prevention group has identified a novel IH prevention strategy in the form of dehydrated human amniotic-chorionic membrane (dHACM). We previously showed that dHACM prevents IH in animal models, and subsequently in a prospective cohort of high-risk patients.

The purpose of this trial is to quantify the efficacy of dHACM in IH prophylaxis by performing a prospective, double-blinded randomized controlled trial. Our specific aim is to test the hypothesis that augmentation of standard abdominal fascia closures with prophylactic, onlay dHACM sheets without fixation will reduce IH formation in a high-risk population.

• Study Type: Interventional
• Enrollment (Anticipated): 533
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Louisiana
    • New Orleans, Louisiana, United States, 70112
      • Recruiting
      • University Medical Center
      • Sub-Investigator: Ian Hodgdon, MD
      • Sub-Investigator: Michael Cook, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: TRIPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: 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.	Biological: dHACM (AmnioWrap); Dehydrated human amnion-chorion membrane (dHACM) is a healing adjunct that has been applied in a broad range of disease, and is FDA registered for wound healing.
NO_INTERVENTION: Control Arm; Patients enrolled in this arm will have routine closure.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Incidence of IH as determined by physical exam or abdominal ultrasound demonstrating a midline fascial defect and hernia sac> 4mm diameter	6 months

Secondary Outcome Measures

Outcome Measure	Time Frame
Intraoperative and postoperative complications	6 months

Collaborators and Investigators

• Sponsor: Louisiana State University Health Sciences Center in New Orleans
• Collaborators: LSUHSC-NO

Study record dates

Study Major Dates

• Study Start (ACTUAL): May 20, 2020
• Primary Completion (ANTICIPATED): May 20, 2022
• Study Completion (ANTICIPATED): May 20, 2022

Study Registration Dates

• First Submitted: June 2, 2020
• First Submitted That Met QC Criteria: June 3, 2020
• First Posted (ACTUAL): June 4, 2020

Study Record Updates

• Last Update Posted (ACTUAL): June 4, 2020
• Last Update Submitted That Met QC Criteria: June 3, 2020
• Last Verified: June 1, 2020

More Information

Terms related to this study

• Keywords: amniotic membrane; incisional hernia; placenta-derived tissue
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pathological Conditions, Anatomical; Hernia; Incisional Hernia
• Other Study ID Numbers: LSUHSC-NO IRB # 19-174

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes