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

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ClinicalTrials.gov Identifier: NCT04417140
Recruitment Status : Recruiting
First Posted : June 4, 2020
Last Update Posted : June 4, 2020
Sponsor:
Collaborator:
LSUHSC-NO
Information provided by (Responsible Party):
Frank Lau, MD, Louisiana State University Health Sciences Center in New Orleans

Study Description
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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.


Condition or disease Intervention/treatment Phase
Incisional Hernia Biological: dHACM (AmnioWrap) Phase 4

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 533 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
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.
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Masking Description:

5.1 General Design Description A double-blinded RCT with two arms: treatment (dHACM) and control. Patients will be recruited from 8 LSUHSC-NO surgeons' practices (Drs. Boudreaux, Stuke, Orangio, Moore, tMarr, Hunt, Greiffenstein, and Barton).

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
Official Title: A Prospective, Double-Blinded, Randomized Controlled Trial of Dehydrated Human Amniotic-Chorionic Membrane for Incisional Hernia Prophylaxis
Actual Study Start Date : May 20, 2020
Estimated Primary Completion Date : May 20, 2022
Estimated Study Completion Date : May 20, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dehydration Hernia

Arms and Interventions
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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.


Outcome Measures
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Primary Outcome Measures :
  1. Incidence of IH as determined by physical exam or abdominal ultrasound demonstrating a midline fascial defect and hernia sac> 4mm diameter [ Time Frame: 6 months ]

Secondary Outcome Measures :
  1. Intraoperative and postoperative complications [ Time Frame: 6 months ]

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04417140


Contacts
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Contact: Frank Lau, MD 504-412-1240 flau@lsuhsc.edu
Contact: Ann D McKendrick, MSW 504-251-3924 amcken@lsuhsc.edu

Locations
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United States, Louisiana
University Medical Center Recruiting
New Orleans, Louisiana, United States, 70112
Contact: Frank Lau, MD    504-412-1240    flau@lsuhsc.edu   
Sub-Investigator: Ian Hodgdon, MD         
Sub-Investigator: Michael Cook, MD         
Sponsors and Collaborators
Louisiana State University Health Sciences Center in New Orleans
LSUHSC-NO
More Information
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Responsible Party: Frank Lau, MD, Associate Professor of Plastic & Reconstructive Surgery, Louisiana State University Health Sciences Center in New Orleans
ClinicalTrials.gov Identifier: NCT04417140    
Other Study ID Numbers: LSUHSC-NO IRB # 19-174
First Posted: June 4, 2020    Key Record Dates
Last Update Posted: June 4, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Keywords provided by Frank Lau, MD, Louisiana State University Health Sciences Center in New Orleans:
amniotic membrane
placenta-derived tissue
incisional hernia
Additional relevant MeSH terms:
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Hernia
Incisional Hernia
Pathological Conditions, Anatomical
Postoperative Complications
Pathologic Processes