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

NCT04417140 | Unknown Phase 4 FDA Drug

• 1 other identifier: LSUHSC-NO IRB # 19-174
• Study Type: interventional
• Target: 533
• Locations: 1 country
• Sites: 1

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.

Conditions

Incisional Hernia

Keywords

amniotic membrane; placenta-derived tissue; incisional hernia

Outcome Measures

Primary Outcomes (1)

• Incidence of IH as determined by physical exam or abdominal ultrasound demonstrating a midline fascial defect and hernia sac> 4mm diameter

  6 months

Secondary Outcomes (1)

• Intraoperative and postoperative complications

  6 months

Study Arms (2)

Treatment Arm-dHACM

EXPERIMENTAL

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)

Control Arm

NO INTERVENTION

Patients enrolled in this arm will have routine closure.

Interventions

dHACM (AmnioWrap) 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.

Treatment Arm-dHACM

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Louisiana State University Health Sciences Center in New Orleans: lead
• LSUHSC-NO: collaborator

Study Sites (1)

University Medical Center

New Orleans, Louisiana, 70112, United States

RECRUITING

MeSH Terms

Conditions

Incisional Hernia

Condition Hierarchy (Ancestors)

Hernia; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Postoperative Complications; Pathologic Processes

Central Study Contacts

Frank Lau, MD

CONTACT

504-412-1240; flau@lsuhsc.edu

Ann D McKendrick, MSW

CONTACT

504-251-3924; amcken@lsuhsc.edu

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Plastic & Reconstructive Surgery

Model Details: 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.

Study Record Dates

• First Submitted: June 2, 2020
• First Posted: June 4, 2020
• Study Start: May 20, 2020
• Primary Completion: May 20, 2022
• Study Completion: May 20, 2022
• Last Updated: June 4, 2020

Record last verified: 2020-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)