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

This study is currently recruiting participants.
Verified December 2013 by Integra LifeSciences Services
Sponsor:
Information provided by (Responsible Party):
Integra LifeSciences Services
ClinicalTrials.gov Identifier:
NCT01704950
First received: October 9, 2012
Last updated: December 11, 2013
Last verified: December 2013
  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 ] [ Designated as safety issue: No ]
    the mean percentage of healing expected at Day 15 after the surgery


Estimated Enrollment: 100
Study Start Date: February 2013
Estimated Study Completion Date: February 2015
Estimated Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01704950

Contacts
Contact: Marilyne Blanc 33437475937 marilyne.blanc@integralife.com

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

No publications provided

Responsible Party: Integra LifeSciences Services
ClinicalTrials.gov Identifier: NCT01704950     History of Changes
Other Study ID Numbers: RECON-EMEA-11
Study First Received: October 9, 2012
Last Updated: December 11, 2013
Health Authority: France: Comité consultatif sur le traitement de l'information en matière de recherche dans le domaine de la santé
France: The Commission nationale de l’informatique et des libertés
Greece: Ethics Committee
United Kingdom: National Health Service
Italy: Ethics Committee
Germany: Ethics Commission

ClinicalTrials.gov processed this record on April 16, 2014