Clinical trial NCT04417140: A Prospective, Double-Blinded, Randomized Controlled Trial of dHACM for Incisional Hernia Prophylaxis
Official title: A Prospective, Double-Blinded, Randomized Controlled Trial of Dehydrated Human Amniotic-Chorionic Membrane for Incisional Hernia Prophylaxis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Incisional Hernia
Keywords: amniotic membrane
placenta-derived tissue
incisional hernia
Lead sponsor: Louisiana State University Health Sciences Center in New Orleans
Sponsor class: OTHER
Collaborators: name: LSUHSC-NO
First posted: 2020-06-04
Enrollment: 533
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 5.1 General Design Description A double-blinded RCT with two arms: treatment (dHACM) and control. Patients will be recruited from LSUHSC-NO surgeons' practices .

Subjects will be randomized to treatment or control at a rate of 1:1, stratified by surgeon. Subjects, nursing staff, and surgeons not present at the time of fascial closure will be kept blinded to the subjects' treatment arm. Computer-generated randomization will be performed in permutated blocks of 20 patients, using SAS version 9.4.
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Incidence of IH as determined by physical exam or abdominal ultrasound demonstrating a midline fascial defect and hernia sac> 4mm diameter
timeFrame: 6 months
Secondary outcomes:
measure: Intraoperative and postoperative complications
timeFrame: 6 months
Other outcomes:
Locations:
city: New Orleans
country: United States
facility: University Medical Center
state: Louisiana
Study officials:
References: