Ventral HerniaPhase 3SIMBIOSENCT01594450
Biological Meshes in Infected Fields: a Randomized Controlled Trial
A Phase 3 study testing Biological mesh and without biological mesh in people with Ventral Hernia, run by University Hospital, Lille at 1 site in France.
Trial summary
The SIMBIOSE trial is a large multicenter phase III prospective randomized controlled single blinded trial comparing the use of biological mesh versus traditional wound care without biological mesh in patients with an infected incisional ventral hernia. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ventral Hernia
- What is being tested?
- Biological mesh and without biological mesh
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- 1 siteFrance
- Study dates
- May 2012to 28 Mar 2019
- 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
- wound infection related to a synthetic non-absorbable mesh for at least 15 days duration
- incisional abdominal hernia with an abcess or fistula, without the presence of a synthetic non-absorbable mesh
- incisional abdominal hernias smaller than 20 centimeter in the 2 largest diameters
- incisional abdominal hernias requiring a surgical procedure
- incisional abdominal hernias amenable to repair with a single biological mesh
- age over 18 years
Who cannot join
- non-infected incisional abdominal hernia
- history of biological mesh placement
- incisional abdominal hernia in contaminated, but non infected field (stoma presence, violation of gastrointestinal tract)
- incisional abdominal hernia larger than 20 x 20 cm
- BMI ≥ 40 kg/m2
- ASA score 4 and 5
Show all 11Show fewer
- immunosuppression (including steroid and cytotoxic therapy)
- chronic disease such as cirrhosis, renal insufficiency with renal dialysis, malignant disease, known collagen disorder
- life expectancy under than 36 months
- allergy to one of the biological mesh components
- pregnancy or breastfeeding
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Use of Biological Mesh Versus Standard Wound Care in Infected Incisional Ventral Hernias: a Multicenter Randomized Controlled Trial, the SIMBIOSE Study
The SIMBIOSE trial is a large multicenter phase III prospective randomized controlled single blinded trial comparing the use of biological mesh versus traditional wound care without biological mesh in patients with an infected incisional ventral hernia. The primary endpoint is 6-month infectious and/or wound morbidity. Secondary endpoints are wound infection rate at 45 days, 3 months and 1 year, recurrent hernia rates at 1, 2 and 3 years, postoperative pain, quality of life, time to healing, need for wound reoperation, impact of the cross-linked mesh structure, and medico-economic evaluation. One hundred patients need to be included.
Read the detailed description
Comparison between standard wound care and the use of biological meshes in infected fields
- Conditions
- Ventral Hernia
- Being tested
- Biological mesh, without biological mesh
- Keywords
- incisional ventral hernia, infected field, biological mesh
- Medical subject headings
- Hernia, Ventral
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biological meshBiological
Also called Biologics, Acellular dermal matrix
patients will undergo the implantation of a biological mesh (after debridement and treatment of the infection) at the same time as the primary operation, or within one month of randomization.
without biological meshProcedure or surgery
Also called standard wound care
patients undergo traditional wound care (debridement and treatment of infection), without placement of a biological mesh. For arm B, the common wound care used follows the normal practice of the treating surgeon, except the placement of the biological mesh, which must not be performed within 6 months of randomization In cases of treatment failure at 6 months, patients of arm B are allowed to undergo any treatment which the treating surgeon views suitable, including a surgical procedure with implantation of a biological mesh
| Study group | Role | What they receive |
|---|---|---|
| biological mesh | Experimental | patients will undergo the implantation of a biological mesh (after debridement and treatment of the infection) at the same time as the primary operation, or within one month of randomization. Receives: Biological: Biological mesh |
| without biological mesh | Active comparator | patients undergo traditional wound care (debridement and treatment of infection), without placement of a biological mesh. For arm B, the common wound care used follows the normal practice of the treating surgeon, except the placement of the biological mesh, which must not be performed within 6 months of randomization. Receives: Procedure: without biological mesh |
What is being measured
The primary outcome is the main question the study is designed to answer.
6-month postoperative morbidity
Measured: 6 months
Secondary outcomes (15)
Day 45 wound infection rate
Measured: 45 days
1-year recurrent hernia rates
Measured: 1 year
postoperative pain
Measured: up to 3 years
quality of life
Measured: up to 3 years
time to cure
Measured: up to 3 years
need for wound reoperation due to infection or hernia recurrence
Measured: up to 3 years
impact of the cross-linked mesh structure on the primary objective
Measured: 6 months
medico-economic evaluation taking into account direct costs related to infected ventral hernia treatment.
Measured: up to 3 years
3 months wound infection rate
Measured: 3 months
1 year wound infection rate
Measured: 1 year
2-year recurrent hernia rates
Measured: 2 years
3-year recurrent hernia rates
Measured: 3 years
impact of the cross-linked mesh structure on the 1-year infection rate
Measured: 1 year
impact of the cross-linked mesh structure on the 1-year recurrence rate
Measured: 1 year
impact of the cross-linked mesh structure on the 3-year recurrence rate
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2012 (estimated)
- Study startMay 2012
- Primary completion28 Mar 2019
- Study completion28 Mar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Ventral 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 110 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Lille
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Guillaume Piessen, MD, PhD, Principal investigator, University Hospital, Lille
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01594450
- Sponsor's protocol ID
- 2011_56
- Other IDs
- 2011-A00059-34
- Acronym
- SIMBIOSE
- Status last verified
- Aug 2019
- First submitted
- 22 Apr 2012
- Last updated
- 22 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Mariette C, Briez N, Denies F, Dervaux B, Duhamel A, Guilbert M, Bruyere E, Robb WB, Piessen G; FRENCH. Use of biological mesh versus standard wound care in infected incisional ventral hernias, the SIMBIOSE study: a study protocol for a randomized multicenter controlled trial. Trials. 2013 May 7;14:131. doi: 10.1186/1745-6215-14-131.
PubMed 23782773
Study at a glance
From the registry record, last updated by the sponsor on 22 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Biological Mesh Versus Standard Wound Care in Infected Incisional Ventral Hernias: a Multicenter Randomized Controlled Trial, the SIMBIOSE Study
- ClinicalTrials.gov ID
- NCT01594450
- Acronym / sponsor ID
- SIMBIOSE / 2011_56
- Conditions
- Ventral Hernia
- Keywords
- incisional ventral hernia, infected field, biological mesh
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 110 participants (actual)
- Lead sponsor
- University Hospital, LilleUniversity, hospital or other
- Study start
- May 2012 (actual)
- Primary completion
- 28 Mar 2019 (actual)
- Study completion
- 28 Mar 2019 (actual)
- First posted
- 9 May 2012 (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 SIMBIOSE trial is a large multicenter phase III prospective randomized controlled single blinded trial comparing the use of biological mesh versus traditional wound care without biological mesh in patients with an infected incisional ventral hernia. The primary endpoint is 6-month infectious and/or wound morbidity. Secondary endpoints are wound infection rate at 45 days, 3 months and 1 year, recurrent hernia rates at 1, 2 and 3 years, postoperative pain, quality of life, time to healing, need for wound reoperation, impact of the cross-linked mesh structure, and medico-economic evaluation. One hundred patients need to be included.
Detailed description
Comparison between standard wound care and the use of biological meshes in infected fields
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| biological mesh | Experimental | Biological: Biological meshpatients will undergo the implantation of a biological mesh (after debridement and treatment of the infection) at the same time as the primary operation, or within one month of randomization. |
| without biological mesh | Active comparator | Procedure: without biological meshpatients undergo traditional wound care (debridement and treatment of infection), without placement of a biological mesh. For arm B, the common wound care used follows the normal practice of the treating surgeon, except the placement of the biological mesh, which must not be performed within 6 months of randomization. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- wound infection related to a synthetic non-absorbable mesh for at least 15 days duration
- incisional abdominal hernia with an abcess or fistula, without the presence of a synthetic non-absorbable mesh
- incisional abdominal hernias smaller than 20 centimeter in the 2 largest diameters
- incisional abdominal hernias requiring a surgical procedure
- incisional abdominal hernias amenable to repair with a single biological mesh
Key exclusion criteria (11 listed)
- non-infected incisional abdominal hernia
- history of biological mesh placement
- incisional abdominal hernia in contaminated, but non infected field (stoma presence, violation of gastrointestinal tract)
- incisional abdominal hernia larger than 20 x 20 cm
- BMI ≥ 40 kg/m2
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 |
|---|---|---|
| Biological meshAlso: Biologics, Acellular dermal matrixpatients will undergo the implantation of a biological mesh (after debridement and treatment of the infection) at the same time as the primary operation, or within one month of randomization. | Biological | biological mesh |
| without biological meshAlso: standard wound carepatients undergo traditional wound care (debridement and treatment of infection), without placement of a biological mesh. For arm B, the common wound care used follows the normal practice of the treating surgeon, except the placement of the biological mesh, which must not be performed within 6 months of randomization In cases of treatment failure at 6 months, patients of arm B are allowed to undergo any treatment which the treating surgeon views suitable, including a surgical procedure with implantation of a biological mesh | Procedure or surgery | without biological mesh |
Primary outcome
6-month postoperative morbidity
Time frame: 6 months
15 secondary outcomes
Day 45 wound infection rate
Time frame: 45 days
1-year recurrent hernia rates
Time frame: 1 year
postoperative pain
Time frame: up to 3 years
quality of life
Time frame: up to 3 years
time to cure
Time frame: up to 3 years
need for wound reoperation due to infection or hernia recurrence
Time frame: up to 3 years
impact of the cross-linked mesh structure on the primary objective
Time frame: 6 months
medico-economic evaluation taking into account direct costs related to infected ventral hernia treatment.
Time frame: up to 3 years
3 months wound infection rate
Time frame: 3 months
1 year wound infection rate
Time frame: 1 year
2-year recurrent hernia rates
Time frame: 2 years
3-year recurrent hernia rates
Time frame: 3 years
impact of the cross-linked mesh structure on the 1-year infection rate
Time frame: 1 year
impact of the cross-linked mesh structure on the 1-year recurrence rate
Time frame: 1 year
impact of the cross-linked mesh structure on the 3-year recurrence rate
Time frame: 3 years
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 22 Dec 2025.
- Results publication: PubMed 23782773Mariette C, Briez N, Denies F, Dervaux B, Duhamel A, Guilbert M, Bruyere E, Robb WB, Piessen G; FRENCH. Use of biological mesh versus standard wound care in infected incisional ventral hernias, the SIMBIOSE study: a study protocol for a randomized multicenter controlled trial. Trials. 2013 May 7;14:131. doi: 10.1186/1745-6215-14-131.
- Individual participant dataSharing planned: Undecided
Related trials for Ventral Hernia
RecruitingPhase 4
Preoperative BOTOX® Injection for Large Ventral Hernia Repair
Hernia Abdominal Wall, Botox Injection
Not yet recruiting
SUTURE TYPE AND RECURRENCE RISK AFTER INCISIONAL HERNIA REPAIR
Ventral Incisional Hernia
Recruiting
Duramesh Versus Minimally Invasive IPOM for High-Risk Umbilical Hernia Repairs
Umbilical Hernia, Ventral Hernia
Active, not recruitingObservational study
ORION Study: Mesh Position and Risk During Subsequent Minimally Invasive Abdominal Surgery
Ventral Hernia Repair
Not yet recruiting
The IMPACT Study: Personalized Physical Therapy for Better Recovery and a Stronger Core After Hernia Surgery
Ventral Hernia, Ventral Incisional Hernia
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.
Guillaume Piessen, MD, PhD principal investigator
University Hospital, Lille
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Biological mesh and without biological mesh in people with Ventral Hernia, run by University Hospital, Lille at 1 site 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 11 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 22 Dec 2025. 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 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?
6-month postoperative morbidity (time frame: 6 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 NCT01594450, which also lists 1 linked publication.
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 22 Dec 2025.