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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01704950
First Posted: October 12, 2012
Last Update Posted: February 25, 2016
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.
Information provided by (Responsible Party):
Integra LifeSciences Services
  Purpose
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.

Condition
Traumatic Wound Reconstruction Wound

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Clinical Outcome of Defect Reconstruction Using IDRT Single Layer : Results From a Prospective Multicentric Trial

Resource links provided by NLM:


Further study details as provided by Integra LifeSciences Services:

Primary Outcome Measures:
  • Rate of graft take [ Time Frame: Day 15 after the surgery ]
    the mean percentage of healing expected at Day 15 after the surgery


Enrollment: 52
Study Start Date: February 2013
Study Completion Date: August 2015
Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Global population
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01704950


Locations
Germany
St Josef Hospital
Bochum, Germany, 44791
Greece
General State Hospital of Athens, "G. Gennimatas" - Department of Plastic Surgery-Microsurgery and Burn Center
Athens, Greece, 11527
Italy
University Hospital "S. Maria della Misericordia" - Plastic Surgery and Burn Center
Udine, Italy, 33100
United Kingdom
Queen Elizabeth Hospital - Burn and Plastic Surgery
Birmingham, United Kingdom, B15 2WB
Sponsors and Collaborators
Integra LifeSciences Services
Investigators
Principal Investigator: Stefanos Papadopoulos General State Hospital of Athens, "G. Gennimatas"
  More Information

Responsible Party: Integra LifeSciences Services
ClinicalTrials.gov Identifier: NCT01704950     History of Changes
Other Study ID Numbers: RECON-EMEA-11
First Submitted: October 9, 2012
First Posted: October 12, 2012
Last Update Posted: February 25, 2016
Last Verified: February 2016

Additional relevant MeSH terms:
Wounds and Injuries