Traumatic WoundNCT01704950
Clinical Outcome of Defect Reconstruction Using IDRT Single Layer : Results From a Prospective Multicentric Trial
An observational study of Traumatic Wound and Reconstruction Wound, run by Integra LifeSciences Services at 4 sites in 4 countries.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Traumatic Wound, Reconstruction Wound
- How many people
- 52 participants
- Where
- 4 sitesin 4 countries
- Study dates
- Feb 2013to Aug 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Global population
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
4 sites in 4 countries.
4 sites in 4 countries
Greece1 site
General State Hospital of Athens, "G. Gennimatas" - Department of Plastic Surgery-Microsurgery and Burn Center
Athens, 11527
Italy1 site
University Hospital "S. Maria della Misericordia" - Plastic Surgery and Burn Center
Udine, 33100
United Kingdom1 site
Queen Elizabeth Hospital - Burn and Plastic Surgery
Birmingham, B15 2WB
About this study
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.
- Conditions
- Traumatic Wound, Reconstruction Wound
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of graft take
the mean percentage of healing expected at Day 15 after the surgery
Measured: Day 15 after the surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2012 (estimated)
- Study startFeb 2013
- Primary completionJul 2014
- Study completionAug 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Traumatic WoundStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Integra LifeSciences Services
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Stefanos Papadopoulos, Principal investigator, General State Hospital of Athens, "G. Gennimatas"
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01704950
- Sponsor's protocol ID
- RECON-EMEA-11
- Status last verified
- Feb 2016
- First submitted
- 9 Oct 2012
- Last updated
- 25 Feb 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Outcome of Defect Reconstruction Using IDRT Single Layer : Results From a Prospective Multicentric Trial
- ClinicalTrials.gov ID
- NCT01704950
- Acronym / sponsor ID
- RECON-EMEA-11
- Conditions
- Traumatic Wound, Reconstruction Wound
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Integra LifeSciences ServicesIndustry (pharma, biotech, devices)
- Study start
- Feb 2013
- Primary completion
- Jul 2014 (actual)
- Study completion
- Aug 2015 (actual)
- First posted
- 12 Oct 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Global population
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Rate of graft take
Time frame: Day 15 after the surgery
the mean percentage of healing expected at Day 15 after the surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Feb 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stefanos Papadopoulos principal investigator
General State Hospital of Athens, "G. Gennimatas"
4 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Traumatic Wound and Reconstruction Wound, run by Integra LifeSciences Services at 4 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Germany, Greece, Italy, United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of graft take (time frame: Day 15 after the surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Feb 2016.