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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University Hospital, Bordeaux
ClinicalTrials.gov Identifier:
NCT00906672
First received: May 20, 2009
Last updated: May 7, 2014
Last verified: May 2014
  Purpose

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 Intervention Phase
Leg Injuries
Ankle Injuries
Foot Injuries
Device: INTEGRA®
Procedure: Flap technique
Phase 3

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

Resource links provided by NLM:


Further study details as provided by University Hospital, Bordeaux:

Primary Outcome Measures:
  • Occurrence of at least one complication requiring a surgical re-intervention [ Time Frame: Within the first 18 months after surgery ] [ Designated as safety issue: Yes ]
  • Persistence of an important / major trouble of the scar measured by a "scar-trouble scale" filled in by the patient. [ Time Frame: at 18 month-follow up ] [ Designated as safety issue: Yes ]
  • Auto-evaluation of patient's scar esthetical result with a visual analog scale. [ Time Frame: at 18 month-follow up ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Occurrence of all post surgical complications [ Time Frame: Within the first 18 months after surgery ] [ Designated as safety issue: Yes ]
  • Duration of hospitalization and healing [ Time Frame: Within the first 18 months after surgery ] [ Designated as safety issue: No ]
  • Period until return to work and re-start of daily activities [ Time Frame: Within the first 18 months after surgery ] [ Designated as safety issue: No ]
  • Ïntensity of scar pain during cares evaluated with a visual analog scale and quality of life (EuroQol) [ Time Frame: Within the first 18 months after surgery ] [ Designated as safety issue: No ]
  • Human and medical requirements [ Time Frame: Within the first 18 months after surgery ] [ Designated as safety issue: No ]

Enrollment: 72
Study Start Date: June 2009
Study Completion Date: January 2014
Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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

  Eligibility

Ages Eligible for Study:   15 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00906672

Locations
France
University Hospital
Besançon, France, 25030
Universiy Hospital Bordeaux,
Bordeaux, France
University Hospital
Clermont-Ferrand, France, 53003
University Hospital
Grenoble, France, 38043
University Hospital
Montpellier, France, 34295
Saint Roch Hospital
Nice, France, 06003
University Hospital
Pointe-à-Pitre, France, 97159
Sponsors and Collaborators
University Hospital, Bordeaux
Investigators
Study Chair: Geneviève CHENE, MD-PHD USMR (University Hospital, Bordeaux)
Study Director: Vincent CASOLI, MD-MHD University Hospital, Bordeaux
  More Information

No publications provided

Responsible Party: University Hospital, Bordeaux
ClinicalTrials.gov Identifier: NCT00906672     History of Changes
Other Study ID Numbers: CHUBX 2008/26
Study First Received: May 20, 2009
Last Updated: May 7, 2014
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by University Hospital, Bordeaux:
Dermal substitute Integra®
Flap
graft
traumatic wound
medico economic costs
esthetical and functional scar results

Additional relevant MeSH terms:
Ankle Injuries
Foot Injuries
Leg Injuries
Wounds and Injuries

ClinicalTrials.gov processed this record on October 23, 2014