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

Sponsor

University Hospital, Bordeaux (Other)

Overall Status

Completed

CT.gov ID

NCT00906672

Collaborator

(none)

Enrollment

Locations

Arms

Duration (Months)

10.3

Patients Per Site

0.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Leg Injuries Ankle Injuries Foot Injuries	Device: INTEGRA® Procedure: Flap technique	Phase 3

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

Study Design

Study Type:

Interventional

Actual Enrollment :

72 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Study Start Date :

Jun 1, 2009

Actual Primary Completion Date :

Jan 1, 2014

Actual Study Completion Date :

Jan 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
Experimental: INTEGRA®	Device: 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.
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.

Arm

Intervention/Treatment

Experimental: INTEGRA®

Device: 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.

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.

Outcome Measures

Primary Outcome Measures

Occurrence of at least one complication requiring a surgical re-intervention [Within the first 18 months after surgery]
Persistence of an important / major trouble of the scar measured by a "scar-trouble scale" filled in by the patient. [at 18 month-follow up]
Auto-evaluation of patient's scar esthetical result with a visual analog scale. [at 18 month-follow up]

Secondary Outcome Measures

Occurrence of all post surgical complications [Within the first 18 months after surgery]
Duration of hospitalization and healing [Within the first 18 months after surgery]
Period until return to work and re-start of daily activities [Within the first 18 months after surgery]
Ïntensity of scar pain during cares evaluated with a visual analog scale and quality of life (EuroQol) [Within the first 18 months after surgery]
Human and medical requirements [Within the first 18 months after surgery]

Eligibility Criteria

Criteria

Ages Eligible for Study:

15 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	Country	Postal Code
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
5	University Hospital	Montpellier	France	34295
6	Saint Roch Hospital	Nice	France	06003
7	University Hospital	Pointe-à-Pitre	France	97159