Medico Economic Evaluation of Dermal Substitute Integra® for Coverage of Inferior Limb Traumatic Skin Loss

NCT ID: NCT00906672

Last Updated: 2014-05-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 72 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-06-30
• Study Completion Date: 2014-01-31

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

Conditions

Leg Injuries; Ankle Injuries; Foot Injuries

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

INTEGRA®

Group Type: EXPERIMENTAL

INTEGRA®

Intervention Type: DEVICE

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.

Flap technique

Group Type: ACTIVE_COMPARATOR

Flap technique

Intervention Type: PROCEDURE

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.

Interventions

INTEGRA®

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.

Intervention Type: DEVICE

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.

Intervention Type: PROCEDURE

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

• Minimum Eligible Age: 15 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Bordeaux

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Geneviève CHENE, MD-PHD

Role: STUDY_CHAIR

USMR (University Hospital, Bordeaux)

Vincent CASOLI, MD-MHD

Role: STUDY_DIRECTOR

University Hospital, Bordeaux

Locations

University Hospital

Besançon, , France

Universiy Hospital Bordeaux,

Bordeaux, , France

University Hospital

Clermont-Ferrand, , France

University Hospital

Grenoble, , France

University Hospital

Montpellier, , France

Saint Roch Hospital

Nice, , France

University Hospital

Pointe à Pitre, , France

Countries

France

Other Identifiers

CHUBX 2008/26

Identifier Type: -

Identifier Source: org_study_id