A Phase 3 interventional study of INTEGRA® and Flap technique in Leg Injuries, Ankle Injuries and Foot Injuries, sponsored by University Hospital, Bordeaux. Completed at 7 sites in France. Open to participants aged 15 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-05-14.
Sponsored by University Hospital, Bordeaux · Phase 3, Interventional, and Treatment
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.
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
58 studies on the registry are indexed under Leg Injuries; 14 are open to participants now.
This study's enrollment of 72 is above the median of 50 across 40 interventional studies indexed under Leg Injuries.
Browse Leg Injuries studies →University Hospital, Bordeaux is the lead sponsor of 783 studies on the registry; 188 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Device: INTEGRA®
Procedure: Flap technique
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.
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.
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
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
This study is completed, as verified in May 2014. You cannot join it, but the record below documents what was studied.
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University Hospital, Bordeaux