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.

Study Overview

• Status: Completed
• Conditions: Traumatic Wound; Reconstruction Wound

• Study Type: Observational
• Enrollment (Actual): 52

Contacts and Locations

Study Locations

• Germany
  • Bochum, Germany, 44791
    • St Josef Hospital
• Greece
  • Athens, Greece, 11527
    • General State Hospital of Athens, "G. Gennimatas" - Department of Plastic Surgery-Microsurgery and Burn Center
• Italy
  • Udine, Italy, 33100
    • University Hospital "S. Maria della Misericordia" - Plastic Surgery and Burn Center
• United Kingdom
  • Birmingham, United Kingdom, B15 2WB
    • Queen Elizabeth Hospital - Burn and Plastic Surgery

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Global population

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of graft take	the mean percentage of healing expected at Day 15 after the surgery	Day 15 after the surgery

Collaborators and Investigators

• Sponsor: Integra LifeSciences Services
• Investigators: Principal Investigator: Stefanos Papadopoulos, General State Hospital of Athens, "G. Gennimatas"

Study record dates

Study Major Dates

• Study Start: February 1, 2013
• Primary Completion (Actual): July 1, 2014
• Study Completion (Actual): August 1, 2015

Study Registration Dates

• First Submitted: October 9, 2012
• First Submitted That Met QC Criteria: October 9, 2012
• First Posted (Estimate): October 12, 2012

Study Record Updates

• Last Update Posted (Estimate): February 25, 2016
• Last Update Submitted That Met QC Criteria: February 24, 2016
• Last Verified: February 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries
• Other Study ID Numbers: RECON-EMEA-11