Incisional HerniaPhase 4NO-HERNIANCT04417140
A Prospective, Double-Blinded, Randomized Controlled Trial of dHACM for Incisional Hernia Prophylaxis
A Phase 4 study testing dHACM (AmnioWrap) in people with Incisional Hernia, run by Louisiana State University Health Sciences Center in New Orleans at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Incisional Hernia
- What is being tested?
- dHACM (AmnioWrap)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 533 participants
- Where
- 1 siteUnited States
- Study dates
- 20 May 2020to 20 May 2022
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Previous intraperitoneal mesh placement
- Previous abdominal incisional hernia
- Emergency procedures
- Patients with inflammatory bowel disease
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
University Medical Center
New Orleans, Louisiana, 70112
Frank Lau, MD, 504-412-1240, flau@lsuhsc.edu
Ian Hodgdon, MD
About this study
Official title: 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.
Read more
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.
Read the 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
- Being tested
- dHACM (AmnioWrap)
- Keywords
- amniotic membrane, placenta-derived tissue, incisional hernia
- Medical subject headings
- Incisional Hernia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Biological: dHACM (AmnioWrap) |
| Control Arm | No intervention | Patients enrolled in this arm will have routine closure. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of IH as determined by physical exam or abdominal ultrasound demonstrating a midline fascial defect and hernia sac> 4mm diameter
Measured: 6 months
Secondary outcomes (1)
Intraoperative and postoperative complications
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2020
- Study start20 May 2020
- Primary completion20 May 2022 (estimated)
- Study completion20 May 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Incisional HerniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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 blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 533 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Louisiana State University Health Sciences Center in New Orleans
- Sponsor type
- University, hospital or other
- Collaborators
- LSUHSC-NO
- Responsible party
- Principal investigator, Frank Lau, MD, Louisiana State University Health Sciences Center in New Orleans
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04417140
- Sponsor's protocol ID
- LSUHSC-NO IRB # 19-174
- Acronym
- NO-HERNIA
- Status last verified
- Jun 2020
- First submitted
- 2 Jun 2020
- Last updated
- 4 Jun 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Double-Blinded, Randomized Controlled Trial of Dehydrated Human Amniotic-Chorionic Membrane for Incisional Hernia Prophylaxis
- ClinicalTrials.gov ID
- NCT04417140
- Acronym / sponsor ID
- NO-HERNIA / LSUHSC-NO IRB # 19-174
- Conditions
- Incisional Hernia
- Keywords
- amniotic membrane, placenta-derived tissue, incisional hernia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 533 participants (estimated)
- Lead sponsor
- Louisiana State University Health Sciences Center in New OrleansUniversity, hospital or other
- Collaborators
- LSUHSC-NO
- Study start
- 20 May 2020 (actual)
- Primary completion
- 20 May 2022 (estimated)
- Study completion
- 20 May 2022 (estimated)
- First posted
- 4 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Treatment Arm-dHACM | Experimental | Biological: dHACM (AmnioWrap)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. |
| Control Arm | No intervention | –Patients enrolled in this arm will have routine closure. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- Previous intraperitoneal mesh placement
- Previous abdominal incisional hernia
- Emergency procedures
- Patients with inflammatory bowel disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Biological | Treatment Arm-dHACM |
Primary outcome
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
1 secondary outcome
Intraoperative and postoperative complications
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing dHACM (AmnioWrap) in people with Incisional Hernia, run by Louisiana State University Health Sciences Center in New Orleans at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 4 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Frank Lau, MD (504-412-1240, flau@lsuhsc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jun 2020.