Parastomal HerniaPhase 4PriSmNCT00771407
Parastomal Reinforcement With Strattice
A Phase 4 study testing Strattice Reconstructive Matrix and Standard ostomy creation in people with Parastomal Hernia, run by LifeCell at 23 sites in United States.
Trial summary
The purpose of this study is to compare the clinical outcomes of patients undergoing surgery for a permanent abdominal wall ostomy with and without placement of Strattice fascial inlay, as measured by postoperative occurence of parastomal hernia. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Parastomal Hernia
- What is being tested?
- Strattice Reconstructive Matrix and Standard ostomy creation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 23 sitesUnited States
- Study dates
- Dec 2008to Jul 2012
- Phase
- Phase 4
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- adults
- need for permanent ileostomy or colostomy
Who cannot join
- history of hernia at new ostomy site
- has previously implanted surgical mesh at site of planned ostomy
- requires a temporary ostomy
- has need for multiple ostomies
- is receiving chronic immunosuppression therapy, has MELD score of > 17, has severe COPD, systemic infection, or known collagen disorder
- is bedridden or otherwise non-ambulatory
Trial locations and contacts
23 sites in 1 country.
23 sites in 1 country
United States23 sites
Albany Medical College
Albany, New York
University of Maryland/Baltimore VA
Baltimore, Maryland
University of Vermont
Burlington, Vermont
University of Illinois
Chicago, Illinois
The Christ Hospital Research
Cincinnati, Ohio
Cleveland Clinic
Cleveland, Ohio, 44195
Duke University Medical Center
Durham, North Carolina
Spectrum Health - Butterworth Hospital
Grand Rapids, Michigan
The Methodist Hospital
Houston, Texas
Indiana University Medical Center
Indianapolis, Indiana
Office of Dr Phillip Fleshner
Los Angeles, California
University of South Alabama
Mobile, Alabama
Louisiana State University
New Orleans, Louisiana
Ochsner Clinic
New Orleans, Louisiana
Mt Sinai Medical Center
New York, New York
Colon & Rectal Surgery Inc
Omaha, Nebraska
University of California at Irvine
Orange, California
Colon and Rectal Surgery Associates Ltd
Saint Paul, Minnesota
Washington University School of Medicine - Barnes Jewish West
St Louis, Missouri
Stanford University Medical Center
Stanford, California
Stony Brook University Medical Center
Stony Brook, New York
University of South Florida
Tampa, Florida
Cleveland Clinic Florida
Weston, Florida
About this study
Official title: A Prospective, Multicenter, Randomized, Controlled, Third-party Blinded Study of Strattice Fascial Inlay for Parastomal Reinforcement in Patients Undergoing Surgery for Permanent Abdominal Wall Ostomies
The purpose of this study is to compare the clinical outcomes of patients undergoing surgery for a permanent abdominal wall ostomy with and without placement of Strattice fascial inlay, as measured by postoperative occurence of parastomal hernia.
- Conditions
- Parastomal Hernia
- Being tested
- Strattice Reconstructive Matrix, Standard ostomy creation
- Keywords
- Ostomy creation, Parastomal hernia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Strattice Reconstructive MatrixDevice
Strattice will be placed as a fascial inlay to support stoma sites
Standard ostomy creationOther
Ostomy will be created as routinely performed
| Study group | Role | What they receive |
|---|---|---|
| Strattice fascial inlay | Active comparator | Strattice will be placed as a fascial inlay to support the ostomy site Receives: Device: Strattice Reconstructive Matrix |
| Standard ostomy construction | Other | Ostomy will be created in the standard fashion Receives: Other: Standard ostomy creation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurrence of Parastomal Hernia in Subjects Undergoing Permanent Abdominal Wall Ostomy Creation With and Without Strattice Fascial Inlay.
Measured: 24 months
Secondary outcomes (3)
Stoma Complications
Measured: 30 days
Stoma Complications
Measured: more than 1 month postoperatively
Stoma Quality of Life
Measured: Serially over 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2008 (estimated)
- Study startDec 2008
- Primary completionFeb 2012
- Study completionJul 2012
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.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Parastomal 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
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- LifeCell
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- James Fleshman, MD, Principal investigator, Washington University, St Louis MO
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00771407
- Sponsor's protocol ID
- LFC2008.01.01
- Acronym
- PriSm
- Status last verified
- Aug 2015
- First submitted
- 10 Oct 2008
- Last updated
- 28 Sep 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Fleshman JW, Beck DE, Hyman N, Wexner SD, Bauer J, George V; PRISM Study Group. A prospective, multicenter, randomized, controlled study of non-cross-linked porcine acellular dermal matrix fascial sublay for parastomal reinforcement in patients undergoing surgery for permanent abdominal wall ostomies. Dis Colon Rectum. 2014 May;57(5):623-31. doi: 10.1097/DCR.0000000000000106.
PubMed 24819103Itani KM, Rosen M, Vargo D, Awad SS, Denoto G 3rd, Butler CE; RICH Study Group. Prospective study of single-stage repair of contaminated hernias using a biologic porcine tissue matrix: the RICH Study. Surgery. 2012 Sep;152(3):498-505. doi: 10.1016/j.surg.2012.04.008. Epub 2012 Jul 3.
PubMed 22763262
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Multicenter, Randomized, Controlled, Third-party Blinded Study of Strattice Fascial Inlay for Parastomal Reinforcement in Patients Undergoing Surgery for Permanent Abdominal Wall Ostomies
- ClinicalTrials.gov ID
- NCT00771407
- Acronym / sponsor ID
- PriSm / LFC2008.01.01
- Conditions
- Parastomal Hernia
- Keywords
- Ostomy creation, Parastomal hernia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- LifeCellIndustry (pharma, biotech, devices)
- Study start
- Dec 2008
- Primary completion
- Feb 2012 (actual)
- Study completion
- Jul 2012 (actual)
- First posted
- 13 Oct 2008 (estimated)
- Results
- Posted 28 Sep 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to compare the clinical outcomes of patients undergoing surgery for a permanent abdominal wall ostomy with and without placement of Strattice fascial inlay, as measured by postoperative occurence of parastomal hernia.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Strattice fascial inlay | Active comparator | Device: Strattice Reconstructive MatrixStrattice will be placed as a fascial inlay to support the ostomy site |
| Standard ostomy construction | Other | Other: Standard ostomy creationOstomy will be created in the standard fashion |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- adults
- need for permanent ileostomy or colostomy
Key exclusion criteria (6 listed)
- history of hernia at new ostomy site
- has previously implanted surgical mesh at site of planned ostomy
- requires a temporary ostomy
- has need for multiple ostomies
- is receiving chronic immunosuppression therapy, has MELD score of > 17, has severe COPD, systemic infection, or known collagen disorder
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 |
|---|---|---|
| Strattice Reconstructive MatrixStrattice will be placed as a fascial inlay to support stoma sites | Device | Strattice fascial inlay |
| Standard ostomy creationOstomy will be created as routinely performed | Other | Standard ostomy construction |
Primary outcome
Occurrence of Parastomal Hernia in Subjects Undergoing Permanent Abdominal Wall Ostomy Creation With and Without Strattice Fascial Inlay.
Time frame: 24 months
3 secondary outcomes
Stoma Complications
Time frame: 30 days
Stoma Complications
Time frame: more than 1 month postoperatively
Stoma Quality of Life
Time frame: Serially over 24 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 24819103Fleshman JW, Beck DE, Hyman N, Wexner SD, Bauer J, George V; PRISM Study Group. A prospective, multicenter, randomized, controlled study of non-cross-linked porcine acellular dermal matrix fascial sublay for parastomal reinforcement in patients undergoing surgery for permanent abdominal wall ostomies. Dis Colon Rectum. 2014 May;57(5):623-31. doi: 10.1097/DCR.0000000000000106.
- Derived from this study: PubMed 22763262Itani KM, Rosen M, Vargo D, Awad SS, Denoto G 3rd, Butler CE; RICH Study Group. Prospective study of single-stage repair of contaminated hernias using a biologic porcine tissue matrix: the RICH Study. Surgery. 2012 Sep;152(3):498-505. doi: 10.1016/j.surg.2012.04.008. Epub 2012 Jul 3.
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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.
James Fleshman, MD principal investigator
Washington University, St Louis MO
23 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Strattice Reconstructive Matrix and Standard ostomy creation in people with Parastomal Hernia, run by LifeCell at 23 sites 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 2 inclusion and 6 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 28 Sep 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 23 sites 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?
Yes. Results are posted in the registry (first posted 28 Sep 2015). 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?
Occurrence of Parastomal Hernia in Subjects Undergoing Permanent Abdominal Wall Ostomy Creation With and Without Strattice Fascial Inlay. (time frame: 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00771407, which also lists 2 linked publications.
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 28 Sep 2015.