HerniorrhaphyNCT01880021
Synthetic Mesh Explant Study
An observational study of Herniorrhaphy and Humans, run by Washington University School of Medicine at 1 site in United States.
Trial summary
The purpose of this study is to determine whether synthetic hernia mesh materials undergo physical and/or chemical changes while in the body. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Herniorrhaphy, Humans, Polypropylene
- How many people
- 111 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2008to Sep 2016
- Phase
- Observational
- 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
- No healthy volunteers
- Adult, Older adult
Study population: Subjects will be recruited from study investigators' patient population.
Who may be able to join
- Age ≥ 18 yrs
- Previous placement of hernia mesh material
- Current need for excision of previous mesh placement or Current need for intra-abdominal surgical procedure
Who cannot join
- Age < 18 yrs
- No retained mesh prosthetic.
- Non surgical candidate
- Prisoner
Trial locations and contacts
1 site in 1 country.
United States1 site
Washington University School of Medicine
St Louis, Missouri, 63110
About this study
Official title: Characterization of Explanted Hernia Meshes From Human Subjects: A Prospective Study
The purpose of this study is to determine whether synthetic hernia mesh materials undergo physical and/or chemical changes while in the body.
What is being measured
The primary outcome is the main question the study is designed to answer.
Fibrosis level of explanted mesh
Each specimen will be graded and given fibrosis score of 0 - 4 to establish the degree of inflammation/foreign body reaction that occurred while mesh was in vivo.
Measured: Within 2 weeks
Secondary outcomes (6)
Tensile strength of explanted mesh
Each specimen will be tested for tensile strength to determine force versus displacement.
Measured: Within 2 weeks
Collagen protein levels of explanted mesh.
The total amount of collagen and non-collagenous proteins in cultured cell layers and tissue sections by differential staining with two dyes, sirius red and fast green. Sirius Red binds to all types of collagen, whereas fast green stains non-collagenous proteins.
Measured: Within 2 weeks
Number of subjects with history of radiation to abdomen/pelvis
Identify possible clinical characteristics which affect mesh degradation.
Measured: Within 2 weeks
Number of subjects with history of chemotherapy
Identify possible clinical characteristics which affect mesh degradation.
Measured: Within 2 weeks
Number of subjects with corticosteroid/immunosuppression therapy
Identify possible clinical characteristics which affect mesh degradation.
Measured: Within 2 weeks
Number of subjects with history of tobacco use
Identify possible clinical characteristics which affect mesh degradation.
Measured: Within 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2013 (estimated)
- Study startMar 2008
- Primary completionSep 2016
- Study completionSep 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HerniorrhaphyStudies of the same condition, open and under way.
- More trials run by Washington University School of MedicineThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 111 participants (actual)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Michael Brunt, MD, Principal investigator, Washington University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01880021
- Sponsor's protocol ID
- 2010-12735
- Status last verified
- Sep 2016
- First submitted
- 31 May 2013
- Last updated
- 23 Sep 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Characterization of Explanted Hernia Meshes From Human Subjects: A Prospective Study
- ClinicalTrials.gov ID
- NCT01880021
- Acronym / sponsor ID
- 2010-12735
- Conditions
- Herniorrhaphy, Humans, Polypropylene, Polytetrafluoroethylene, Histology, Materials Testing
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 111 participants (actual)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Study start
- Mar 2008
- Primary completion
- Sep 2016 (actual)
- Study completion
- Sep 2016 (actual)
- First posted
- 18 Jun 2013 (estimated)
- 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.
The purpose of this study is to determine whether synthetic hernia mesh materials undergo physical and/or chemical changes while in the body.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects will be recruited from study investigators' patient population.
Key inclusion criteria (3 listed)
- Age ≥ 18 yrs
- Previous placement of hernia mesh material
- Current need for excision of previous mesh placement or Current need for intra-abdominal surgical procedure
Key exclusion criteria (4 listed)
- Age < 18 yrs
- No retained mesh prosthetic.
- Non surgical candidate
- Prisoner
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Fibrosis level of explanted mesh
Time frame: Within 2 weeks
Each specimen will be graded and given fibrosis score of 0 - 4 to establish the degree of inflammation/foreign body reaction that occurred while mesh was in vivo.
6 secondary outcomes
Tensile strength of explanted mesh
Time frame: Within 2 weeks
Collagen protein levels of explanted mesh.
Time frame: Within 2 weeks
Number of subjects with history of radiation to abdomen/pelvis
Time frame: Within 2 weeks
Number of subjects with history of chemotherapy
Time frame: Within 2 weeks
Number of subjects with corticosteroid/immunosuppression therapy
Time frame: Within 2 weeks
Number of subjects with history of tobacco use
Time frame: Within 2 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2016.
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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.
Michael Brunt, MD principal investigator
Washington University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Herniorrhaphy and Humans, run by Washington University School of Medicine 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 3 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: finished, as of the sponsor's last update on 23 Sep 2016. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Fibrosis level of explanted mesh (time frame: Within 2 weeks). 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 23 Sep 2016.