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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title:

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 Summary:

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 f
Sponsor: University Hospital, Bordeaux

Current Primary Outcome:

  • Occurrence of at least one complication requiring a surgical re-intervention [ Time Frame: 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. [ Time Frame: at 18 month-follow up ]
  • Auto-evaluation of patient's scar esthetical result with a visual analog scale. [ Time Frame: at 18 month-follow up ]


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Occurrence of all post surgical complications [ Time Frame: Within the first 18 months after surgery ]
  • Duration of hospitalization and healing [ Time Frame: Within the first 18 months after surgery ]
  • Period until return to work and re-start of daily activities [ Time Frame: Within the first 18 months after surgery ]
  • 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 ]
  • Human and medical requirements [ Time Frame: Within the first 18 months after surgery ]


Original Secondary Outcome: Same as current

Information By: University Hospital, Bordeaux

Dates:
Date Received: May 20, 2009
Date Started: June 2009
Date Completion:
Last Updated: May 7, 2014
Last Verified: May 2014