Clinical trial NCT00906672: Medico Economic Evaluation of Dermal Substitute Integra® for Coverage of Inferior Limb Traumatic Skin Loss
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Leg Injuries
Ankle Injuries
Foot Injuries
Keywords: Dermal substitute Integra®
Flap
graft
traumatic wound
medico economic costs
esthetical and functional scar results
Lead sponsor: University Hospital, Bordeaux
Sponsor class: OTHER
First posted: 2009-05-21
Enrollment: 72
Sex: ALL
Minimum age (years): 15
Maximum age (years): 80
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Occurrence of at least one complication requiring a surgical re-intervention
timeFrame: Within the first 18 months after surgery
measure: Persistence of an important / major trouble of the scar measured by a "scar-trouble scale" filled in by the patient.
timeFrame: at 18 month-follow up
measure: Auto-evaluation of patient's scar esthetical result with a visual analog scale.
timeFrame: at 18 month-follow up
Secondary outcomes:
measure: Occurrence of all post surgical complications
timeFrame: Within the first 18 months after surgery
measure: Duration of hospitalization and healing
timeFrame: Within the first 18 months after surgery
measure: Period until return to work and re-start of daily activities
timeFrame: Within the first 18 months after surgery
measure: Ïntensity of scar pain during cares evaluated with a visual analog scale and quality of life (EuroQol)
timeFrame: Within the first 18 months after surgery
measure: Human and medical requirements
timeFrame: Within the first 18 months after surgery
Other outcomes:
Locations:
city: Besançon
country: France
facility: University Hospital
city: Bordeaux
country: France
facility: Universiy Hospital Bordeaux,
city: Clermont-Ferrand
country: France
facility: University Hospital
city: Grenoble
country: France
facility: University Hospital
city: Montpellier
country: France
facility: University Hospital
city: Nice
country: France
facility: Saint Roch Hospital
city: Pointe-à-Pitre
country: France
facility: University Hospital
Study officials:
affiliation: USMR (University Hospital, Bordeaux)
name: Geneviève CHENE, MD-PHD
role: STUDY_CHAIR
affiliation: University Hospital, Bordeaux
name: Vincent CASOLI, MD-MHD
role: STUDY_DIRECTOR
References: