Medico Economic Evaluation of Dermal Substitute Integra® for Coverage of Inferior Limb Traumatic Skin Loss
Condition: Leg Injuries; Ankle Injuries; Foot Injuries
MeSH terms: Wounds and Injuries; Ankle Injuries; Foot Injuries; Leg Injuries
Study type: Interventional
Phase: Phase 3

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.
    

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
    

Intervention name(s): INTEGRA®; Flap technique
Intervention type(s): Device; Procedure
Intervention description(s): 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.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Dermal substitute Integra®; Flap; graft; traumatic wound; medico economic costs; esthetical and functional scar results