Hernia Repair With Compartment SyndromeFlex HDNCT01597128
Feasibility Study of The Use of FLEX HD® Surgical Implant or STRATTICE® Reconstructive Tissue Matrix in The Closure of Abdominal Wall Defects With Component Separation in Clean or Contaminated Cases
A study testing Flex HD and Strattice in people with Hernia Repair With Compartment Syndrome, run by John Roth at 1 site in United States.
Trial summary
This study examines the feasibility of using Flex HD® Surgical Implant or STRATTICE® Reconstructive Tissue Matrixin the repair of hernias. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Hernia Repair With Compartment Syndrome
- What is being tested?
- Flex HD and Strattice
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2011to May 2015
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Be 18-85 years of age (inclusive)
- Patient has a ventral or incisional hernia with at least one of the following characteristics
- Hernia is at least 6cm in transverse dimension
- History of 2 or more prior ventral or incisional hernia repairs
- Active or prior infection of the abdominal wall
- Enterocutaneous fistula to the anterior abdominal wall
Show all 12Show fewer
- Mesh requiring mesh removal which would result in a hernia at least 6cm in transverse dimension
- Patients is scheduled to undergo component separation hernia repair
- Have an ASA Score of 3 or less
- Have a BMI between 20 and 55
- Be a candidate for primary approximation of skin and wound following hernia repair
- Have a life expectancy of at least 2 years
Who cannot join
- Have loss of abdominal domain such that the operation would be impractical or would adversely effect respiratory or cardiovascular function to an unacceptable degree
- Be a candidate for emergency surgery that would make giving valid Informed Consent impractical
- Be currently taking part in another clinical study that conflicts with the current study
- Have active generalized peritonitis or intraperitoneal sepsis
- Have active necrotizing fasciitis
- Have active abdominal compartment syndrome
Show all 10Show fewer
- Have active untreated metabolic or systemic illness
- Have known active malignancy present
- Be unable to give valid informed consent or comply with required follow-up schedule
- Suffer from mental capacity sufficiently severe to make informed consent unobtainable
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Kentucky Medical Center
Lexington, Kentucky, 40536
About this study
This study examines the feasibility of using Flex HD® Surgical Implant or STRATTICE® Reconstructive Tissue Matrixin the repair of hernias.
Read the detailed description
At least 100,000 ventral hernia repairs are performed in the U.S. each year. Recently, biologically-based implants derived from acellular human dermis, porcine small intestinal submucosa, and porcine dermis have been reported in a variety of complex abdominal wall repair procedures. A variety of surgical techniques and implant placement methods have been described, with no one standard technique achieving precedence. Biologic implant reinforcement of a myofascial closure by means of component separation, or at a minimum, where three-layer fascial approximation is not possible, sublay placement (i.e., closure of the posterior rectus sheath under the implant) are described strategies. These techniques allow placement of the implant against an intact fascial layer and may improve implant incorporation into host tissue.
The Musculoskeletal Transplant Foundation (MTF) has manufactured and processed Flex HD Acellular Hydrated Dermis. This acellular dermis is derived from human skin. In complicated ventral hernia repairs, this type of graft tissue is necessary. Flex HD has been shown to reduce operative time, lower operative costs and provides minimal elasticity.
The Musculoskeletal Transplant Foundation (MTF) is a non-profit service organization dedicated to providing quality allograft tissue through a commitment to excellence in education, research, recovery and care for recipients, donors and their families. MTF is a national consortium comprised of academic medical institutions, organ procurement organizations and tissue recovery organizations. From their inception, they have been both donor-focused and surgeon-driven. Since their inception in 1987, MTF has recovered more than 60,000 donors and distributed more than 3 million grafts for transplantation.
The Foundation was established by surgeons and teaching institutions to meet the need for a high quality and consistent allograft supply.
- Conditions
- Hernia Repair With Compartment Syndrome
- Being tested
- Flex HD, Strattice
- Keywords
- Hernia, human tissue, mesh
- Medical subject headings
- Hernia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Flex HDDevice
Flex HD mesh for hernia repair
StratticeDevice
Strattice mesh for hernia repair
| Study group | Role | What they receive |
|---|---|---|
| Flex HD | Active comparator | Mesh Type Receives: Device: Flex HD |
| Strattice | Active comparator | Use of a second mesh type Receives: Device: Strattice |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hernia Recurrence
Recurrence of hernia based on physical exam and /or CT scan.
Measured: 12 months
Wound Occurrence
superficial or deep wound infection, abscess, seroma, cellulitis, necrosis, hematoma or wound dehiscence.
Measured: 12 months
Wound Occurrence: Deep Wound Infection
Measured: 12 Months
Wound Occurrence: Wound Abscess
Measured: 12 Months
Wound Occurrence: Wound Seroma
Measured: 12 Months
Wound Occurrence: Wound Cellulitis
Measured: 12 Months
Wound Occurrence: Wound Dehiscence
Measured: 12 Months
Wound Occurrence: Superficial Wound Infection
Superficial wound infection
Measured: 12 months
Change in SF12 Physical Component Score Between Pre-operation and 12 Months Post-operation
Change in SF12 Physical Component Score from pre-operation to 12 months post-operation: Scores were normalized with 50 equal to the national norm and 40 equal to one standard deviation below the norm, so a 12 month difference of 10 would equal a 1 standard deviation change; An increase is better.
Measured: 12 months
Change in SF12 Mental Component Score Between Pre-operation and 12 Months Post-operation
Change in SF12 Mental Component Score from pre-operation to 12 months post-operation: Scores were normalized with 50 equal to the national norm and 40 equal to one standard deviation below the norm; An increase is better.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2012 (estimated)
- Study startMar 2011
- Primary completionMay 2015
- Study completionMay 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Hernia Repair With Compartment SyndromeStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- John Roth
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, John Roth, University of Kentucky
- Investigators
- John S Roth, M.D., Principal investigator, University of Kentucky
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01597128
- Sponsor's protocol ID
- 11-0080-P6A
- Acronym
- Flex HD
- Status last verified
- Oct 2016
- First submitted
- 9 May 2012
- Last updated
- 16 Mar 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility Study of The Use of FLEX HD® Surgical Implant or STRATTICE® Reconstructive Tissue Matrix in The Closure of Abdominal Wall Defects With Component Separation in Clean or Contaminated Cases
- ClinicalTrials.gov ID
- NCT01597128
- Acronym / sponsor ID
- Flex HD / 11-0080-P6A
- Conditions
- Hernia Repair With Compartment Syndrome
- Keywords
- Hernia, human tissue, mesh
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- John RothUniversity, hospital or other
- Study start
- Mar 2011
- Primary completion
- May 2015 (actual)
- Study completion
- May 2015 (actual)
- First posted
- 11 May 2012 (estimated)
- Results
- Posted 16 Mar 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study examines the feasibility of using Flex HD® Surgical Implant or STRATTICE® Reconstructive Tissue Matrixin the repair of hernias.
Detailed description
At least 100,000 ventral hernia repairs are performed in the U.S. each year. Recently, biologically-based implants derived from acellular human dermis, porcine small intestinal submucosa, and porcine dermis have been reported in a variety of complex abdominal wall repair procedures. A variety of surgical techniques and implant placement methods have been described, with no one standard technique achieving precedence. Biologic implant reinforcement of a myofascial closure by means of component separation, or at a minimum, where three-layer fascial approximation is not possible, sublay placement (i.e., closure of the posterior rectus sheath under the implant) are described strategies. These techniques allow placement of the implant against an intact fascial layer and may improve implant incorporation into host tissue.
The Musculoskeletal Transplant Foundation (MTF) has manufactured and processed Flex HD Acellular Hydrated Dermis. This acellular dermis is derived from human skin. In complicated ventral hernia repairs, this type of graft tissue is necessary. Flex HD has been shown to reduce operative time, lower operative costs and provides minimal elasticity.
The Musculoskeletal Transplant Foundation (MTF) is a non-profit service organization dedicated to providing quality allograft tissue through a commitment to excellence in education, research, recovery and care for recipients, donors and their families. MTF is a national consortium comprised of academic medical institutions, organ procurement organizations and tissue recovery organizations. From their inception, they have been both donor-focused and surgeon-driven. Since their inception in 1987, MTF has recovered more than 60,000 donors and distributed more than 3 million grafts for transplantation.
The Foundation was established by surgeons and teaching institutions to meet the need for a high quality and consistent allograft supply.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Flex HD | Active comparator | Device: Flex HDMesh Type |
| Strattice | Active comparator | Device: StratticeUse of a second mesh type |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Be 18-85 years of age (inclusive)
- Patient has a ventral or incisional hernia with at least one of the following characteristics
- Patients is scheduled to undergo component separation hernia repair
- Have an ASA Score of 3 or less
- Have a BMI between 20 and 55
Key exclusion criteria (10 listed)
- Have loss of abdominal domain such that the operation would be impractical or would adversely effect respiratory or cardiovascular function to an unacceptable degree
- Be a candidate for emergency surgery that would make giving valid Informed Consent impractical
- Be currently taking part in another clinical study that conflicts with the current study
- Have active generalized peritonitis or intraperitoneal sepsis
- Have active necrotizing fasciitis
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 |
|---|---|---|
| Flex HDFlex HD mesh for hernia repair | Device | Flex HD |
| StratticeStrattice mesh for hernia repair | Device | Strattice |
Primary outcome
Hernia Recurrence
Time frame: 12 months
Recurrence of hernia based on physical exam and /or CT scan.
Wound Occurrence
Time frame: 12 months
superficial or deep wound infection, abscess, seroma, cellulitis, necrosis, hematoma or wound dehiscence.
Wound Occurrence: Deep Wound Infection
Time frame: 12 Months
Wound Occurrence: Wound Abscess
Time frame: 12 Months
Wound Occurrence: Wound Seroma
Time frame: 12 Months
Wound Occurrence: Wound Cellulitis
Time frame: 12 Months
Wound Occurrence: Wound Dehiscence
Time frame: 12 Months
Wound Occurrence: Superficial Wound Infection
Time frame: 12 months
Superficial wound infection
Change in SF12 Physical Component Score Between Pre-operation and 12 Months Post-operation
Time frame: 12 months
Change in SF12 Physical Component Score from pre-operation to 12 months post-operation: Scores were normalized with 50 equal to the national norm and 40 equal to one standard deviation below the norm, so a 12 month difference of 10 would equal a 1 standard deviation change; An increase is better.
Change in SF12 Mental Component Score Between Pre-operation and 12 Months Post-operation
Time frame: 12 months
Change in SF12 Mental Component Score from pre-operation to 12 months post-operation: Scores were normalized with 50 equal to the national norm and 40 equal to one standard deviation below the norm; An increase is better.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Mar 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Musculoskeletal Transplant FoundationLink provided by the sponsor.
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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.
John S Roth, M.D. principal investigator
University of Kentucky
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Flex HD and Strattice in people with Hernia Repair With Compartment Syndrome, run by John Roth 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 12 inclusion and 10 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: finished, as of the sponsor's last update on 16 Mar 2017. 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 16 Mar 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hernia Recurrence (time frame: 12 months). The study lists 10 primary outcomes in all. 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 16 Mar 2017.