Medico Economic Evaluation of Dermal Substitute Integra® for Coverage of Inferior Limb Traumatic Skin Loss (INTEGRA®)
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.
Procedure: Flap technique
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
- Occurrence of at least one complication requiring a surgical re-intervention [ Time Frame: Within the first 18 months after surgery ] [ Designated as safety issue: Yes ]
- 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 ] [ Designated as safety issue: Yes ]
- Auto-evaluation of patient's scar esthetical result with a visual analog scale. [ Time Frame: at 18 month-follow up ] [ Designated as safety issue: No ]
- Occurrence of all post surgical complications [ Time Frame: Within the first 18 months after surgery ] [ Designated as safety issue: Yes ]
- Duration of hospitalization and healing [ Time Frame: Within the first 18 months after surgery ] [ Designated as safety issue: No ]
- Period until return to work and re-start of daily activities [ Time Frame: Within the first 18 months after surgery ] [ Designated as safety issue: No ]
- 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 ] [ Designated as safety issue: No ]
- Human and medical requirements [ Time Frame: Within the first 18 months after surgery ] [ Designated as safety issue: No ]
|Study Start Date:||June 2009|
|Estimated Study Completion Date:||December 2013|
|Estimated Primary Completion Date:||December 2013 (Final data collection date for primary outcome measure)|
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.
|Active Comparator: Flap technique||
Procedure: Flap technique
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.
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
|Besançon, France, 25030|
|Universiy Hospital Bordeaux,|
|Clermont-Ferrand, France, 53003|
|Grenoble, France, 38043|
|Montpellier, France, 34295|
|Saint Roch Hospital|
|Nice, France, 06003|
|Pointe-à-Pitre, France, 97159|
|Study Chair:||Geneviève CHENE, MD-PHD||USMR (University Hospital, Bordeaux)|
|Study Director:||Vincent CASOLI, MD-MHD||University Hospital, Bordeaux|