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

Traumatic Wound Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01704950
• Other study ID #: RECON-EMEA-11
• Status: Completed
• Phase: N/A
• First received: October 9, 2012
• Last updated: February 24, 2016
• Start date: February 2013
• Est. completion date: August 2015

Study information

• Verified date: February 2016
• Source: Integra LifeSciences Services
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Comité consultatif sur le traitement de l'information en matière de recherche dans le domaine de la santéFrance: The Commission nationale de l’informatique et des libertésGreece: Ethics CommitteeUnited Kingdom: National Health ServiceItaly: Ethics CommitteeGermany: Ethics Commission
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 52
• Est. completion date: August 2015
• Est. primary completion date: July 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Reconstruction Wound
• Traumatic Wound

Locations

Country	Name	City	State
Germany	St Josef Hospital	Bochum
Greece	General State Hospital of Athens, "G. Gennimatas" - Department of Plastic Surgery-Microsurgery and Burn Center	Athens
Italy	University Hospital "S. Maria della Misericordia" - Plastic Surgery and Burn Center	Udine
United Kingdom	Queen Elizabeth Hospital - Burn and Plastic Surgery	Birmingham

Sponsors (1)

Lead Sponsor	Collaborator
Integra LifeSciences Services

Countries where clinical trial is conducted

Germany,  Greece,  Italy,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of graft take	the mean percentage of healing expected at Day 15 after the surgery	Day 15 after the surgery	No