Leg InjuriesPhase 3INTEGRA®NCT00906672
Medico Economic Evaluation of Dermal Substitute Integra® for Coverage of Inferior Limb Traumatic Skin Loss
A Phase 3 study testing INTEGRA® and Flap technique in people with Leg Injuries and Ankle Injuries, run by University Hospital, Bordeaux at 7 sites in France.
Trial summary
Comparison of 2 techniques of surgery on patients with inferior limb traumatic wounds: the innovative technique Integra® and the technique of reference: the flap surgery. Read more about this study
- Who is it for?
- Ages 15 to 80 years
- Conditions the study is for
- Leg Injuries, Ankle Injuries, Foot Injuries
- What is being tested?
- INTEGRA® and Flap technique
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 7 sitesFrance
- Study dates
- Jun 2009to Jan 2014
- 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 15 to 80 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- patient with skin loss traumatic or chronic wound
- wound located from mid third of the leg to distal extremity of feet
- with muscle and/or tendon and/or bone and/or articulation exposure
- requiring a first surgical intervention for the coverage of the skin loss
- patient eligible to the Integra® surgery techniques
- patient with social security affiliation
- written informed consent signed by the patient or representative
Who cannot join
- Bone fracture located in the skin loss
- Non traumatic wound
- Wound with muscle exposure only
- Immunocompromised patient
- Allergy to bovine collagen, glycosaminoglycans or silicon
- patient with an healthstate that compromise the 18 months Follow-up
- pregnant women / who intend to become pregnant within the 18 months of follow-up
- Patient under administrative or legal supervision
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
France7 sites
University Hospital
Besançon, 25030
Universiy Hospital Bordeaux,
Bordeaux
University Hospital
Clermont-Ferrand, 53003
University Hospital
Grenoble, 38043
University Hospital
Montpellier, 34295
Saint Roch Hospital
Nice, 06003
University Hospital
Pointe à Pitre, 97159
About this study
Comparison of 2 techniques of surgery on patients with inferior limb traumatic wounds: the innovative technique Integra® and the technique of reference: the flap surgery.
Read the detailed description
Traumatic skin loss with bone or tendon exposure essentially affects inferior limbs. There are considered serious as they often lead to functional and esthetical consequences, and they generally affect young people.
Flap surgery is the treatment of reference for these skin losses. This technique requires expensive material and a lot of medical staff. The intervention and duration of hospitalisation are often long with heavy medication. Post surgery complications or disabling sequelea involve surgical re-interventions which increase duration of hospital stay and medical staff availability.
The dermal substitute Integra® (Integra LifeSciences Corporation) is an advanced wound care device comprised of a porous matrix of cross-linked bovine tendon collagen and glycosaminoglycan and a semi-permeable polysiloxane (silicone layer). This medical device allows formation of a neoderm. The silicon layer is a temporary layer which is removed when the neoderm is totally built. This surgery is fast, non-invasive, with short hospital stay and limited complications which can be treated easily.
Objective of the study: to assess medico-economic interest of innovative surgery using dermal substitute Integra® compared to the reference using flap surgery in the treatment of traumatic skin loss of inferior limbs. Assessment will be based on re-interventions incidence, long-term functional and esthetical scar results and total cost of each technique.
Study design: multicenter, randomized, open label, parallel design, clinical trial in 12 French plastic surgery / burn care centres.
Planned number of enrolled patients: 120 (80 patients receiving Integra® and 40 patients receiving the flap surgery). Patients will be randomized in 1 of the 2 groups, with an imbalance in favour of the innovative technique.
Duration of enrollment: 24 months Duration of patient follow up: 18 months
- Conditions
- Leg Injuries, Ankle Injuries, Foot Injuries
- Being tested
- INTEGRA®, Flap technique
- Keywords
- Dermal substitute Integra®, Flap, graft, traumatic wound, medico economic costs, esthetical and functional scar results
- Medical subject headings
- Leg Injuries, Ankle Injuries, Foot Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
INTEGRA®Device
A plaque of dermal substitute Integra® is adjusted to the size of the wound and sutured. A negative pressure bandage is placed on the wound. 7 to 11 days post surgery, the Integra® silicone layer is removed and the neoderm is covered with a skin graft.
Flap techniqueProcedure or surgery
A flap is a part of skin, cutaneous tissue or muscle that is taken from an healthy area of the body and put on the damaged area for coverage.
| Study group | Role | What they receive |
|---|---|---|
| INTEGRA® | Experimental | Not described Receives: Device: INTEGRA® |
| Flap technique | Active comparator | Not described Receives: Procedure: Flap technique |
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurrence of at least one complication requiring a surgical re-intervention
Measured: Within the first 18 months after surgery
Persistence of an important / major trouble of the scar measured by a "scar-trouble scale" filled in by the patient.
Measured: at 18 month-follow up
Auto-evaluation of patient's scar esthetical result with a visual analog scale.
Measured: at 18 month-follow up
Secondary outcomes (5)
Occurrence of all post surgical complications
Measured: Within the first 18 months after surgery
Duration of hospitalization and healing
Measured: Within the first 18 months after surgery
Period until return to work and re-start of daily activities
Measured: Within the first 18 months after surgery
Ïntensity of scar pain during cares evaluated with a visual analog scale and quality of life (EuroQol)
Measured: Within the first 18 months after surgery
Human and medical requirements
Measured: Within the first 18 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2009 (estimated)
- Study startJun 2009
- Primary completionJan 2014
- Study completionJan 2014
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 Leg InjuriesStudies of the same condition, open and under way.
- More trials run by University Hospital, BordeauxThe 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
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Bordeaux
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Geneviève CHENE, MD-PHD, Study chair, USMR (University Hospital, Bordeaux)Vincent CASOLI, MD-MHD, Study director, University Hospital, Bordeaux
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00906672
- Sponsor's protocol ID
- CHUBX 2008/26
- Other IDs
- 2009-A00014-53
- Acronym
- INTEGRA®
- Status last verified
- May 2014
- First submitted
- 20 May 2009
- Last updated
- 14 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Leclere FM, Desnouveaux E, Choughri H, Casoli V. Acellular dermal matrix: New applications for free flap pedicle coverage - A prospective study in 10 patients. J Cosmet Laser Ther. 2018 Aug;20(4):200-204. doi: 10.1080/14764172.2016.1248439. Epub 2018 Apr 18.
PubMed 27779431
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Medico Economic Evaluation of Dermal Substitute Integra® for Coverage of Inferior Limb Traumatic Skin Loss
- ClinicalTrials.gov ID
- NCT00906672
- Acronym / sponsor ID
- INTEGRA® / CHUBX 2008/26
- Conditions
- Leg Injuries, Ankle Injuries, Foot Injuries
- Keywords
- Dermal substitute Integra®, Flap, graft, traumatic wound, medico economic costs, esthetical and functional scar results
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- University Hospital, BordeauxUniversity, hospital or other
- Study start
- Jun 2009
- Primary completion
- Jan 2014 (actual)
- Study completion
- Jan 2014 (actual)
- First posted
- 21 May 2009 (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.
Comparison of 2 techniques of surgery on patients with inferior limb traumatic wounds: the innovative technique Integra® and the technique of reference: the flap surgery.
Detailed description
Traumatic skin loss with bone or tendon exposure essentially affects inferior limbs. There are considered serious as they often lead to functional and esthetical consequences, and they generally affect young people.
Flap surgery is the treatment of reference for these skin losses. This technique requires expensive material and a lot of medical staff. The intervention and duration of hospitalisation are often long with heavy medication. Post surgery complications or disabling sequelea involve surgical re-interventions which increase duration of hospital stay and medical staff availability.
The dermal substitute Integra® (Integra LifeSciences Corporation) is an advanced wound care device comprised of a porous matrix of cross-linked bovine tendon collagen and glycosaminoglycan and a semi-permeable polysiloxane (silicone layer). This medical device allows formation of a neoderm. The silicon layer is a temporary layer which is removed when the neoderm is totally built. This surgery is fast, non-invasive, with short hospital stay and limited complications which can be treated easily.
Objective of the study: to assess medico-economic interest of innovative surgery using dermal substitute Integra® compared to the reference using flap surgery in the treatment of traumatic skin loss of inferior limbs. Assessment will be based on re-interventions incidence, long-term functional and esthetical scar results and total cost of each technique.
Study design: multicenter, randomized, open label, parallel design, clinical trial in 12 French plastic surgery / burn care centres.
Planned number of enrolled patients: 120 (80 patients receiving Integra® and 40 patients receiving the flap surgery). Patients will be randomized in 1 of the 2 groups, with an imbalance in favour of the innovative technique.
Duration of enrollment: 24 months Duration of patient follow up: 18 months
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| INTEGRA® | Experimental | Device: INTEGRA® |
| Flap technique | Active comparator | Procedure: Flap technique |
Who may qualify
- Ages
- 15 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- patient with skin loss traumatic or chronic wound
- wound located from mid third of the leg to distal extremity of feet
- with muscle and/or tendon and/or bone and/or articulation exposure
- requiring a first surgical intervention for the coverage of the skin loss
- patient eligible to the Integra® surgery techniques
Key exclusion criteria (8 listed)
- Bone fracture located in the skin loss
- Non traumatic wound
- Wound with muscle exposure only
- Immunocompromised patient
- Allergy to bovine collagen, glycosaminoglycans or silicon
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 |
|---|---|---|
| INTEGRA®A plaque of dermal substitute Integra® is adjusted to the size of the wound and sutured. A negative pressure bandage is placed on the wound. 7 to 11 days post surgery, the Integra® silicone layer is removed and the neoderm is covered with a skin graft. | Device | INTEGRA® |
| Flap techniqueA flap is a part of skin, cutaneous tissue or muscle that is taken from an healthy area of the body and put on the damaged area for coverage. | Procedure or surgery | Flap technique |
Primary outcome
Occurrence of at least one complication requiring a surgical re-intervention
Time frame: Within the first 18 months after surgery
Persistence of an important / major trouble of the scar measured by a "scar-trouble scale" filled in by the patient.
Time frame: at 18 month-follow up
Auto-evaluation of patient's scar esthetical result with a visual analog scale.
Time frame: at 18 month-follow up
5 secondary outcomes
Occurrence of all post surgical complications
Time frame: Within the first 18 months after surgery
Duration of hospitalization and healing
Time frame: Within the first 18 months after surgery
Period until return to work and re-start of daily activities
Time frame: Within the first 18 months after surgery
Ïntensity of scar pain during cares evaluated with a visual analog scale and quality of life (EuroQol)
Time frame: Within the first 18 months after surgery
Human and medical requirements
Time frame: Within the first 18 months after surgery
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 14 May 2026.
- Results publication: PubMed 27779431Leclere FM, Desnouveaux E, Choughri H, Casoli V. Acellular dermal matrix: New applications for free flap pedicle coverage - A prospective study in 10 patients. J Cosmet Laser Ther. 2018 Aug;20(4):200-204. doi: 10.1080/14764172.2016.1248439. Epub 2018 Apr 18.
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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.
Geneviève CHENE, MD-PHD study chair
USMR (University Hospital, Bordeaux)
Vincent CASOLI, MD-MHD study director
University Hospital, Bordeaux
7 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 INTEGRA® and Flap technique in people with Leg Injuries and Ankle Injuries, run by University Hospital, Bordeaux at 7 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 7 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 14 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 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?
Occurrence of at least one complication requiring a surgical re-intervention (time frame: Within the first 18 months after surgery). The study lists 3 primary outcomes in all. 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 NCT00906672, 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 14 May 2026.