Completed

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

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What is being collected

Data Collection

Collected from today forward - Prospective
Who is being recruted

Over 18 Years
+12 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Cohort

Tracking disease incidence in order to identify risk factors and understand disease progression over time.
Observational
Study Start: February 2013
See protocol details

Summary

Principal SponsorIntegra LifeSciences Services
Last updated: February 25, 2016
Sourced from a government-validated database.Claim as a partner

Study start date: February 1, 2013

Actual date on which the first participant was enrolled.

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.

NCT01704950
Principal SponsorIntegra LifeSciences Services
Last updated: February 25, 2016
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

52 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Cohort

These studies follow a group of individuals with common characteristics (such as a condition or birth year) over a specific period to study health outcomes or exposures.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Criteria

4 inclusion criteria required to participate
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
8 exclusion criteria prevent from participating
Addition of any substances (growth factor, stem cells,...) in the IDRT SL during the surgery
Chronic wound (with no healing since 6 months)
Immunosuppressed patient
Patient with a corticoid treatment with a daily dose greater than 5 mg
Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Study Objectives

Study Objectives

Primary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 4 locations

St Josef Hospital

Bochum, GermanyOpen St Josef Hospital in Google Maps

General State Hospital of Athens, "G. Gennimatas" - Department of Plastic Surgery-Microsurgery and Burn Center

Athens, Greece

University Hospital "S. Maria della Misericordia" - Plastic Surgery and Burn Center

Udine, Italy

Queen Elizabeth Hospital - Burn and Plastic Surgery

Birmingham, United Kingdom
Completed4 Study Centers