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

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ClinicalTrials.gov Identifier: NCT01704950
Recruitment Status : Completed
First Posted : October 12, 2012
Last Update Posted : February 25, 2016
Sponsor:
Information provided by (Responsible Party):
Integra LifeSciences Services

October 9, 2012
October 12, 2012
February 25, 2016
February 2013
July 2014   (Final data collection date for primary outcome measure)
Rate of graft take [ Time Frame: Day 15 after the surgery ]
the mean percentage of healing expected at Day 15 after the surgery
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Complete list of historical versions of study NCT01704950 on ClinicalTrials.gov Archive Site
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Clinical Outcome of Defect Reconstruction Using IDRT Single Layer : Results From a Prospective Multicentric Trial
Clinical Outcome of Defect Reconstruction Using IDRT Single Layer : Results From a Prospective Multicentric Trial
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.
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Observational
Observational Model: Cohort
Time Perspective: Prospective
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Non-Probability Sample
Global population
  • Traumatic Wound
  • Reconstruction Wound
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
52
100
August 2015
July 2014   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
Germany,   Greece,   Italy,   United Kingdom
 
 
NCT01704950
RECON-EMEA-11
No
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Integra LifeSciences Services
Integra LifeSciences Services
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Principal Investigator: Stefanos Papadopoulos General State Hospital of Athens, "G. Gennimatas"
Integra LifeSciences Services
February 2016