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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01704950

Enrollment

Registered

2012-10-12

Start date

2013-02-28

Completion date

2015-08-31

Last updated

2016-02-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Reconstruction Wound, Traumatic Wound

Brief summary

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame	Description
Rate of graft take	Day 15 after the surgery	the mean percentage of healing expected at Day 15 after the surgery

Countries

Germany, Greece, Italy, United Kingdom

Outcome results