Clinical Outcome of Defect Reconstruction Using IDRT Single Layer : Results From a Prospective Multicentric Trial
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government.
Read our disclaimer for details.
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.
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, Learn About Clinical Studies.
Layout table for eligibility information
Ages Eligible for Study:
18 Years and older (Adult, Older Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
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
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