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COMPLETED
NCT00906672
PHASE3

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

Sponsor: University Hospital, Bordeaux

View on ClinicalTrials.gov

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.

Key Details

Gender

All

Age Range

15 Years - 80 Years

Study Type

INTERVENTIONAL

Enrollment

72

Start Date

2009-06

Completion Date

2014-01

Last Updated

2026-05-14

Healthy Volunteers

No

Interventions

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.

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.

Locations (7)

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