Clinical Outcome of Defect Reconstruction Using IDRT Single Layer : Results From a Prospective Multicentric Trial

Integra LifeSciences

Status: Completed

Conditions: Reconstruction Wound; Traumatic Wound

Study type: Observational

Funder types: Industry

Identifiers

NCT01704950

RECON-EMEA-11

Details and patient eligibility

About

The aim of this study is to provide data and the guidelines for the use of IDRT SL in small wounds, acute and chronic (less than 6 months), showing the benefits and the easy to use of this product as a one stage procedure.

Enrollment: 52 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age ≥ 18 years
• Patient with 1 traumatic wound (burns included) or 1 reconstruction wound (oncological wounds included)
• Patients for whom the surgeon has recommended that an INTEGRA® SL matrix be implanted (even if the patient is not taking part in the study) with a Split Thickness Skin Graft in the same operating procedure
• Wound treated with only one layer of a maximum size 10cm*12.5cm

Exclusion criteria

• Immunosuppressed patient
• Chronic wound (with no healing since 6 months)
• Addition of any substances (growth factor, stem cells,...) in the IDRT SL during the surgery
• Patient with a corticoid treatment with a daily dose greater than 5 mg
• Patients whose life expectancy is less than 12 months
• Patients whose mental health or health condition (Visual deficiency, Alzheimers...) would compromise completion of the self-evaluation questionnaires
• Patient with an hypersensitivity to bovine collagen, chondroitin
• Patient with clinical signs of infection (fever, pain, colour, swelling,...) and for whom the investigator diagnosed infection