Potentially Contaminated Hernia RepairPhase 3TutomeshNCT01073072
Study Comparing Tutomesh® Repair to Conventional Surgical Techniques in Potentially Contaminated Hernia Repair and Abdominal Wall Reconstruction
A Phase 3 study testing Conventional technique and Technique Tutomesh® in people with Potentially Contaminated Hernia Repair and Potentially Contaminated Abdominal Wall Reconstruction, run by Centre Hospitalier Régional Universitaire Montpellier at 19 sites in France.
Trial summary
This is a multicentric prospective randomized study comparing technique of tension-free repair with placement of a bovine pericardium bioprosthesis (Tutopatch® and Tutomesh®) to current conventional surgical techniques in potentially contaminated hernia repair and abdominal wall reconstruction. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Potentially Contaminated Hernia Repair, Potentially Contaminated Abdominal Wall Reconstruction
- What is being tested?
- Conventional technique and Technique Tutomesh®
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 134 participants
- Where
- 19 sitesFrance
- Study dates
- Jan 2009to Oct 2011
- Phase
- Phase 3
- 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
Who may be able to join
- Patient presenting with an incisional hernia or complicated hernia contraindicating the use of non absorbable mesh:
- Infected incisional hernia: abdominal wall abscess, chronic fistula
- Incisional hernia with high septic potential: incisional hernia with strangulation of one or more intestinal loops, repair of incisional hernia during surgery requiring opening of the digestive tube (digestive resection, restoration of digestive continuity, gastro-intestinal perforation, peritonitis from digestive origin)
- Recurrent incisional hernia with problem of cutaneous healing
- Incisional hernia requiring important intestinal adhesiolysis
- Patients signing informed consent form after reading and understanding the information letter _ Patients are more than 18 year old
Who cannot join
- Patient with major anesthetic risk (ASA 4)
- Patient suffering from immunodepression or under immunosuppressor treatment (corticoids…)
- Patients already enrolled in another study
- Patient suffering from severe disease not allowing a 1-year follow-up
- Patient refusing to be enrolled after consulting the information letter
- Patient presenting with a too large incisional hernia, superior to 140x200 mm
- Pregnancy
Trial locations and contacts
19 sites in 1 country.
19 sites in 1 country
France19 sites
CH Aix en Provence
Aix-en-Provence, 13616
CHU Amiens
Amiens, 80054
Ch Antibes-Juan les pins
Antibes
Clinique de la Casamance
Aubagne, 13400
CH Avignon
Avignon, 84900
CHG Beziers
Béziers, 34525
CHU Jean Verdier
Bondy, 93143
CHU Fréjus
Fréjus, 83600
CHU Grenoble
Grenoble - La Tronche, 38700
Hôpital Nord
Marseille, 13915
CH St Eloi
Montpellier, 34000
CHU Nantes
Nantes
CHU Archet II
Nice, 06202
CH Nimes
Nîmes
CHU Hôtel Dieu
Paris, 75004
CH Salon de Provence
Salon-de-Provence, 13658
CH Hautepierre
Strasbourg, 67200
CHU Rangueil
Toulouse, 31059
CHU Trousseau
Tours, 37000
About this study
Official title: Multicentric Prospective Randomized Study Comparing Technique of Tension-free Repair With Placement of a Bovine Pericardium Bioprosthesis (Tutopatch® and Tutomesh®) to Current Conventional Surgical Techniques in Potentially Contaminated Hernia Repair and Abdominal Wall Reconstruction
This is a multicentric prospective randomized study comparing technique of tension-free repair with placement of a bovine pericardium bioprosthesis (Tutopatch® and Tutomesh®) to current conventional surgical techniques in potentially contaminated hernia repair and abdominal wall reconstruction.
The hypothesis is that using Tutomesh® prostheses reduces the risk of postoperative complications at 30 days in the treatment of incisional hernias or complicated abdominal wall hernias (ref early complications) for potentially contaminated fields.
- Conditions
- Potentially Contaminated Hernia Repair, Potentially Contaminated Abdominal Wall Reconstruction
- Being tested
- Conventional technique, Technique Tutomesh®
- Keywords
- bovine pericardium bioprosthesis, contamination, hernia repair, abdominal wall reconstruction, Tutomesh, Tutopatch, Potentially Contaminated Hernia Repair, Potentially Contaminated Abdominal Wall Reconstruction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Conventional techniqueProcedure or surgery
Conventional technique to repair potentially contaminated incisional or abdominal wall hernias
Technique Tutomesh®Procedure or surgery
Technique of abdominal wall reconstruction or hernia repair strengthened by Tutomesh® in potentially contaminated environment.
| Study group | Role | What they receive |
|---|---|---|
| Tutomesh | Experimental | Technique of abdominal wall reconstruction strengthened by Tutomesh® Receives: Procedure: Technique Tutomesh® |
| conventional repair | Active comparator | Conventional technique to repair incisional or abdominal wall hernias Receives: Procedure: Conventional technique |
What is being measured
The primary outcome is the main question the study is designed to answer.
risk of postoperative complications: occurrence of complications related to pathology or surgery will be evaluated with the report of adverse events and emergency visits
Measured: 30 days
Secondary outcomes (4)
recurrence risk: Assessment of relapse thanks to emergency visits and to adverse events' report
Measured: 1 year
the impact on postoperative pain: Assessment of postoperative pain by postponing analgesics
Measured: 1 year
the socio-economic impact will be evaluated with the concomitant treatment and hospitalisations.
Measured: 1 year
the impact on patients' quality of life: The evaluation of patient's quality of life will be done with the questionnaire quality of life SF12
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2010 (estimated)
- Study startJan 2009
- Primary completionOct 2010
- Study completionOct 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Potentially Contaminated Hernia RepairStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 134 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Régional Universitaire Montpellier
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, David Nocca, Centre Hospitalier Régional Universitaire Montpellier
- Investigators
- David Nocca, Dr, Principal investigator, University Hospital, Montpellier
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01073072
- Sponsor's protocol ID
- 2008-A00875-50
- Acronym
- Tutomesh
- Status last verified
- Mar 2012
- First submitted
- 19 Feb 2010
- Last updated
- 16 Mar 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicentric Prospective Randomized Study Comparing Technique of Tension-free Repair With Placement of a Bovine Pericardium Bioprosthesis (Tutopatch® and Tutomesh®) to Current Conventional Surgical Techniques in Potentially Contaminated Hernia Repair and Abdominal Wall Reconstruction
- ClinicalTrials.gov ID
- NCT01073072
- Acronym / sponsor ID
- Tutomesh / 2008-A00875-50
- Conditions
- Potentially Contaminated Hernia Repair, Potentially Contaminated Abdominal Wall Reconstruction
- Keywords
- bovine pericardium bioprosthesis, contamination, hernia repair, abdominal wall reconstruction, Tutomesh, Tutopatch, Potentially Contaminated Hernia Repair, Potentially Contaminated Abdominal Wall Reconstruction
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 134 participants (actual)
- Lead sponsor
- Centre Hospitalier Régional Universitaire MontpellierUniversity, hospital or other
- Study start
- Jan 2009
- Primary completion
- Oct 2010 (actual)
- Study completion
- Oct 2011 (actual)
- First posted
- 23 Feb 2010 (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.
This is a multicentric prospective randomized study comparing technique of tension-free repair with placement of a bovine pericardium bioprosthesis (Tutopatch® and Tutomesh®) to current conventional surgical techniques in potentially contaminated hernia repair and abdominal wall reconstruction.
The hypothesis is that using Tutomesh® prostheses reduces the risk of postoperative complications at 30 days in the treatment of incisional hernias or complicated abdominal wall hernias (ref early complications) for potentially contaminated fields.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tutomesh | Experimental | Procedure: Technique Tutomesh®Technique of abdominal wall reconstruction strengthened by Tutomesh® |
| conventional repair | Active comparator | Procedure: Conventional techniqueConventional technique to repair incisional or abdominal wall hernias |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patient presenting with an incisional hernia or complicated hernia contraindicating the use of non absorbable mesh:
- Patients signing informed consent form after reading and understanding the information letter _ Patients are more than 18 year old
Key exclusion criteria (7 listed)
- Patient with major anesthetic risk (ASA 4)
- Patient suffering from immunodepression or under immunosuppressor treatment (corticoids…)
- Patients already enrolled in another study
- Patient suffering from severe disease not allowing a 1-year follow-up
- Patient refusing to be enrolled after consulting the information letter
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 |
|---|---|---|
| Conventional techniqueConventional technique to repair potentially contaminated incisional or abdominal wall hernias | Procedure or surgery | conventional repair |
| Technique Tutomesh®Technique of abdominal wall reconstruction or hernia repair strengthened by Tutomesh® in potentially contaminated environment. | Procedure or surgery | Tutomesh |
Primary outcome
risk of postoperative complications: occurrence of complications related to pathology or surgery will be evaluated with the report of adverse events and emergency visits
Time frame: 30 days
4 secondary outcomes
recurrence risk: Assessment of relapse thanks to emergency visits and to adverse events' report
Time frame: 1 year
the impact on postoperative pain: Assessment of postoperative pain by postponing analgesics
Time frame: 1 year
the socio-economic impact will be evaluated with the concomitant treatment and hospitalisations.
Time frame: 1 year
the impact on patients' quality of life: The evaluation of patient's quality of life will be done with the questionnaire quality of life SF12
Time frame: 1 year
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 16 Mar 2012.
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.
David Nocca, Dr principal investigator
University Hospital, Montpellier
19 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Conventional technique and Technique Tutomesh® in people with Potentially Contaminated Hernia Repair and Potentially Contaminated Abdominal Wall Reconstruction, run by Centre Hospitalier Régional Universitaire Montpellier at 19 sites in France.
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 6 inclusion and 7 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 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 19 sites in France. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
risk of postoperative complications: occurrence of complications related to pathology or surgery will be evaluated with the report of adverse events and emergency visits (time frame: 30 days). 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 2012; AzTrials last refreshed its copy on 6 Nov 2026.