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

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

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.

Condition or disease
Traumatic Wound Reconstruction Wound

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Study Type : Observational
Actual Enrollment : 52 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Clinical Outcome of Defect Reconstruction Using IDRT Single Layer : Results From a Prospective Multicentric Trial
Study Start Date : February 2013
Actual Primary Completion Date : July 2014
Actual Study Completion Date : August 2015

Resource links provided by the National Library of Medicine

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

Information from the National Library of Medicine

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

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

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 identifier (NCT number): NCT01704950

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St Josef Hospital
Bochum, Germany, 44791
General State Hospital of Athens, "G. Gennimatas" - Department of Plastic Surgery-Microsurgery and Burn Center
Athens, Greece, 11527
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
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Principal Investigator: Stefanos Papadopoulos General State Hospital of Athens, "G. Gennimatas"
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Responsible Party: Integra LifeSciences Services Identifier: NCT01704950    
Other Study ID Numbers: RECON-EMEA-11
First Posted: October 12, 2012    Key Record Dates
Last Update Posted: February 25, 2016
Last Verified: February 2016
Additional relevant MeSH terms:
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Wounds and Injuries