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

NCT ID: NCT04417140

Last Updated: 2020-06-04

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 533 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-05-20
• Study Completion Date: 2022-05-20

Brief Summary

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.

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.

Conditions

Incisional Hernia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: TRIPLE

Study Groups

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.

Group Type: EXPERIMENTAL

dHACM (AmnioWrap)

Intervention Type: BIOLOGICAL

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.

Control Arm

Patients enrolled in this arm will have routine closure.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: BIOLOGICAL

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

LSUHSC-NO

UNKNOWN

Sponsor Role: collaborator

Louisiana State University Health Sciences Center in New Orleans

OTHER

Sponsor Role: lead

Responsible Party

Frank Lau, MD

Associate Professor of Plastic & Reconstructive Surgery

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

University Medical Center

New Orleans, Louisiana, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Frank Lau, MD

Role: CONTACT

flau@lsuhsc.edu

504-412-1240

Ann D McKendrick, MSW

Role: CONTACT

amcken@lsuhsc.edu

504-251-3924

Facility Contacts

Frank Lau, MD

Role: primary

flau@lsuhsc.edu

504-412-1240

Other Identifiers

LSUHSC-NO IRB # 19-174

Identifier Type: -

Identifier Source: org_study_id