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

This study is currently recruiting participants. (see Contacts and Locations)
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
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, see Learn About Clinical Studies.

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 July 24, 2014