HerniaRICHNCT00617357
Repair of Infected or Contaminated Hernias
A study testing LTM (Strattice Reconstructive Tissue Matrix) in people with Hernia, run by LifeCell at 15 sites in United States.
Trial summary
This is a prospective, multicenter, interventional, observational, open label, single arm, longitudinal evaluation of ventral incisional hernia repair using LTM in contaminated or infected sites. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hernia
- What is being tested?
- LTM (Strattice Reconstructive Tissue Matrix)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 83 participants
- Where
- 15 sitesUnited States
- Study dates
- Sep 2007to Dec 2010
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- is an adult ≥18 years old.
- has need of open abdominal incisional repair of a contaminated or infected site
- has an estimated hernia size of >9cm2 by physical exam
Who cannot join
- has a nidus of chronic colonization
- has a systemic infection at the time of repair.
- has chronic conditions: hepatic cirrhosis (w/ or w/o ascites); renal failure w/ hemo- or peritoneal dialysis; incomplete resection of malignant disease; or defined collagen disorder.
- requires chronic immunosuppressive therapy, including steroids or cytotoxic agents.
- is bedridden or otherwise non-ambulatory.
- is ASA Class 4 or 5.
- has a BMI >40.
- has conditions that would adversely affect subject safety, as per product labeling, including sensitivities to pork or porcine products.
Trial locations and contacts
15 sites in 1 country.
15 sites in 1 country
United States15 sites
University of Michigan Medical Center
Ann Arbor, Michigan
University of Maryland Medical Center
Baltimore, Maryland
University of North Carolina Hospitals
Chapel Hill, North Carolina
University Hospitals of Cleveland
Cleveland, Ohio
University of Missouri-Columbia Medical Center
Columbia, Missouri
Baylor College of Medicine
Houston, Texas
University of Texas - MD Anderson Cancer Center
Houston, Texas
University of California-San Diego Medical Center
La Jolla, California
North Shore University Hospital-Long Island Jewish Health System
Manhasset, New York, 11030
Hospital of St Rafael
New Haven, Connecticut
Louisiana State University Health Sciences Center
New Orleans, Louisiana, 70121
Tulane University Medical Center
New Orleans, Louisiana
Oregon Health Sciences University
Portland, Oregon, 97239
University of Utah Medical Center
Salt Lake City, Utah
Washington University
St Louis, Missouri
About this study
Official title: A Multicenter, Prospective, Observational Evaluation of Repair of Infected or Contaminated Hernias (RICH) Using LTM
This is a prospective, multicenter, interventional, observational, open label, single arm, longitudinal evaluation of ventral incisional hernia repair using LTM in contaminated or infected sites. Three interim analyses are planned to examine the incidence of surgical site events, postoperative resumption of activities and hernia recurrence.
- Conditions
- Hernia
- Being tested
- LTM (Strattice Reconstructive Tissue Matrix)
- Keywords
- incisional hernia, abdominal hernia repair, Ventral incisional hernia repair
- Medical subject headings
- Hernia, Incisional Hernia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LTM (Strattice Reconstructive Tissue Matrix)Device
Surgical mesh
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Strattice Reconstructive Tissue Matrix Receives: Device: LTM (Strattice Reconstructive Tissue Matrix) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Wound Events
Wound Events are defined as those events which occurred in the area of the hernia repair and the repair site, including seroma, hematoma, dehiscence, infection, abscess, fistula, and re-herniation.
Measured: Postoperatively up to 24 months
Secondary outcomes (6)
Activities Assessment Scale (AAS)
The AAS includes 13 items covering a broad sample of sedentary, movement-related and graded-intensity physical activities. Respondents are asked to rate the degree of difficulty performing each of these activities in the previous 24 hours on a 5-point scale from "No difficulty" to "Not able to do it." The AAS has three subscales: sedentary activities (items 1-4); ambulatory activities (items 6-8); work/exercise activities (items 11-13). The AAS total and subscale scores are numerically transformed to produce a range of 0-100, with higher values indicating greater functional activity.
Measured: Baseline
Activities Assessment Scale (AAS)
The AAS includes 13 items covering a broad sample of sedentary, movement-related and graded-intensity physical activities. Respondents are asked to rate the degree of difficulty performing each of these activities in the previous 24 hours on a 5-point scale from "No difficulty" to "Not able to do it." The AAS has three subscales: sedentary activities (items 1-4); ambulatory activities (items 6-8); work/exercise activities (items 11-13). The AAS total and subscale scores are transformed to produce a range of 0-100, with higher values indicating greater functional activity.
Measured: 30 Days
Activities Assessment Scale (AAS)
The AAS includes 13 items covering a broad sample of sedentary, movement-related and graded-intensity physical activities. Respondents are asked to rate the degree of difficulty performing each of these activities in the previous 24 hours on a 5-point scale from "No difficulty" to "Not able to do it." The AAS has three subscales: sedentary activities (items 1-4); ambulatory activities (items 6-8); work/exercise activities (items 11-13). The AAS total and subscale scores are transformed to produce a range of 0-100, with higher values indicating greater functional activity.
Measured: 3 Months
Activities Assessment Scale (AAS)
The AAS includes 13 items covering a broad sample of sedentary, movement-related and graded-intensity physical activities. Respondents are asked to rate the degree of difficulty performing each of these activities in the previous 24 hours on a 5-point scale from "No difficulty" to "Not able to do it." The AAS has three subscales: sedentary activities (items 1-4); ambulatory activities (items 6-8); work/exercise activities (items 11-13). The AAS total and subscale scores are transformed to produce a range of 0-100, with higher values indicating greater functional activity.
Measured: 6 Months
Activities Assessment Scale (AAS)
The AAS includes 13 items covering a broad sample of sedentary, movement-related and graded-intensity physical activities. Respondents are asked to rate the degree of difficulty performing each of these activities in the previous 24 hours on a 5-point scale from "No difficulty" to "Not able to do it." The AAS has three subscales: sedentary activities (items 1-4); ambulatory activities (items 6-8); work/exercise activities (items 11-13). The AAS total and subscale scores are transformed to produce a range of 0-100, with higher values indicating greater functional activity.
Measured: 12 Months
Activities Assessment Scale (AAS)
The AAS includes 13 items covering a broad sample of sedentary, movement-related and graded-intensity physical activities. Respondents are asked to rate the degree of difficulty performing each of these activities in the previous 24 hours on a 5-point scale from "No difficulty" to "Not able to do it." The AAS has three subscales: sedentary activities (items 1-4); ambulatory activities (items 6-8); work/exercise activities (items 11-13). The AAS total and subscale scores are transformed to produce a range of 0-100, with higher values indicating greater functional activity.
Measured: 24 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2008 (estimated)
- Study startSep 2007
- Primary completionDec 2010
- Study completionDec 2010
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 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 83 participants (actual)
Sponsor and investigators
- Lead sponsor
- LifeCell
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Kamal Itani, MD, Principal investigator, Boston VA Healthcare System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00617357
- Sponsor's protocol ID
- LFC2007.02.01
- Acronym
- RICH
- Status last verified
- Oct 2015
- First submitted
- 14 Jan 2008
- Last updated
- 1 Dec 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Itani 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 22763262Rosen MJ, Denoto G, Itani KM, Butler C, Vargo D, Smiell J, Rutan R. Evaluation of surgical outcomes of retro-rectus versus intraperitoneal reinforcement with bio-prosthetic mesh in the repair of contaminated ventral hernias. Hernia. 2013 Feb;17(1):31-5. doi: 10.1007/s10029-012-0909-2. Epub 2012 Mar 14.
PubMed 22415440
Study at a glance
From the registry record, last updated by the sponsor on 1 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Prospective, Observational Evaluation of Repair of Infected or Contaminated Hernias (RICH) Using LTM
- ClinicalTrials.gov ID
- NCT00617357
- Acronym / sponsor ID
- RICH / LFC2007.02.01
- Conditions
- Hernia
- Keywords
- incisional hernia, abdominal hernia repair, Ventral incisional hernia repair
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 83 participants (actual)
- Lead sponsor
- LifeCellIndustry (pharma, biotech, devices)
- Study start
- Sep 2007
- Primary completion
- Dec 2010 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 18 Feb 2008 (estimated)
- Results
- Posted 1 Dec 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a prospective, multicenter, interventional, observational, open label, single arm, longitudinal evaluation of ventral incisional hernia repair using LTM in contaminated or infected sites. Three interim analyses are planned to examine the incidence of surgical site events, postoperative resumption of activities and hernia recurrence.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Device: LTM (Strattice Reconstructive Tissue Matrix)Strattice Reconstructive Tissue Matrix |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- is an adult ≥18 years old.
- has need of open abdominal incisional repair of a contaminated or infected site
- has an estimated hernia size of >9cm2 by physical exam
Key exclusion criteria (8 listed)
- has a nidus of chronic colonization
- has a systemic infection at the time of repair.
- has chronic conditions: hepatic cirrhosis (w/ or w/o ascites); renal failure w/ hemo- or peritoneal dialysis; incomplete resection of malignant disease; or defined collagen disorder.
- requires chronic immunosuppressive therapy, including steroids or cytotoxic agents.
- is bedridden or otherwise non-ambulatory.
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 |
|---|---|---|
| LTM (Strattice Reconstructive Tissue Matrix)Surgical mesh | Device | 1 |
Primary outcome
Incidence of Wound Events
Time frame: Postoperatively up to 24 months
Wound Events are defined as those events which occurred in the area of the hernia repair and the repair site, including seroma, hematoma, dehiscence, infection, abscess, fistula, and re-herniation.
6 secondary outcomes
Activities Assessment Scale (AAS)
Time frame: Baseline
Activities Assessment Scale (AAS)
Time frame: 30 Days
Activities Assessment Scale (AAS)
Time frame: 3 Months
Activities Assessment Scale (AAS)
Time frame: 6 Months
Activities Assessment Scale (AAS)
Time frame: 12 Months
Activities Assessment Scale (AAS)
Time frame: 24 Months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Dec 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: 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.
- Derived from this study: PubMed 22415440Rosen MJ, Denoto G, Itani KM, Butler C, Vargo D, Smiell J, Rutan R. Evaluation of surgical outcomes of retro-rectus versus intraperitoneal reinforcement with bio-prosthetic mesh in the repair of contaminated ventral hernias. Hernia. 2013 Feb;17(1):31-5. doi: 10.1007/s10029-012-0909-2. Epub 2012 Mar 14.
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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.
Kamal Itani, MD principal investigator
Boston VA Healthcare System
15 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing LTM (Strattice Reconstructive Tissue Matrix) in people with Hernia, run by LifeCell at 15 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 3 inclusion and 8 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 1 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 1 Dec 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?
Incidence of Wound Events (time frame: Postoperatively up to 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 NCT00617357, 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 1 Dec 2015.