Status:
COMPLETED
Medico Economic Evaluation of Dermal Substitute Integra® for Coverage of Inferior Limb Traumatic Skin Loss
Lead Sponsor:
University Hospital, Bordeaux
Conditions:
Leg Injuries
Ankle Injuries
Eligibility:
All Genders
15-80 years
Phase:
PHASE3
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 affec...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2014
Estimated Enrollment :
72 Patients enrolled
Trial Details
Trial ID
NCT00906672
Start Date
June 1 2009
End Date
January 1 2014
Last Update
May 8 2014
Active Locations (7)
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1
University Hospital
Besançon, France, 25030
2
Universiy Hospital Bordeaux,
Bordeaux, France
3
University Hospital
Clermont-Ferrand, France, 53003
4
University Hospital
Grenoble, France, 38043