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

Ankle Injuries Clinical Trial

— INTEGRA®  

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00906672
• Other study ID #: CHUBX 2008/26
• Status: Completed
• Phase: Phase 3
• First received: May 20, 2009
• Last updated: May 7, 2014
• Start date: June 2009
• Est. completion date: January 2014

Study information

• Verified date: May 2014
• Source: University Hospital, Bordeaux
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 72
• Est. completion date: January 2014
• Est. primary completion date: January 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 15 Years to 80 Years

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Ankle Injuries
• Foot Injuries
• Leg Injuries

Intervention

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

Country	Name	City	State
France	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

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Bordeaux

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Occurrence of at least one complication requiring a surgical re-intervention		Within the first 18 months after surgery	Yes
Primary	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	Yes
Primary	Auto-evaluation of patient's scar esthetical result with a visual analog scale.		at 18 month-follow up	No
Secondary	Occurrence of all post surgical complications		Within the first 18 months after surgery	Yes
Secondary	Duration of hospitalization and healing		Within the first 18 months after surgery	No
Secondary	Period until return to work and re-start of daily activities		Within the first 18 months after surgery	No
Secondary	Ïntensity of scar pain during cares evaluated with a visual analog scale and quality of life (EuroQol)		Within the first 18 months after surgery	No
Secondary	Human and medical requirements		Within the first 18 months after surgery	No