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CompletedNCT01704950Updated Feb 25, 2016

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

An observational study in Traumatic Wound and Reconstruction Wound, sponsored by Integra LifeSciences Services. Completed at 4 sites in 4 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2016-02-25.

Sponsored by Integra LifeSciences Services · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
52
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Traumatic Wound
  • Reconstruction Wound

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03

In context

Wounds and Injuries

5,056 studies on the registry are indexed under Wounds and Injuries; 859 are open to participants now.

This study's enrollment of 52 is below the median of 135 across 1,597 observational studies indexed under Wounds and Injuries.

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Lead sponsor

Integra LifeSciences Services is the lead sponsor of 9 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
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

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
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
52 participants (actual)
06

What researchers measure

Primary outcomes

  1. Rate of graft take

    the mean percentage of healing expected at Day 15 after the surgery

    Time frame: Day 15 after the surgery

07

Study locations

4 sites
  • St Josef Hospital
    Bochum, 44791, Germany
  • General State Hospital of Athens, "G. Gennimatas" - Department of Plastic Surgery-Microsurgery and Burn Center
    Athens, 11527, Greece
  • University Hospital "S. Maria della Misericordia" - Plastic Surgery and Burn Center
    Udine, 33100, Italy
  • Queen Elizabeth Hospital - Burn and Plastic Surgery
    Birmingham, B15 2WB, United Kingdom
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 25, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01704950
Lead sponsor
Integra LifeSciences Services
Responsible party
Sponsor
First posted
Oct 12, 2012
Start date
Feb 2013
Primary completion
Jul 2014
Completion
Aug 2015
Last update
Feb 25, 2016

Study contacts

Stefanos Papadopoulos
principal investigator · General State Hospital of Athens, "G. Gennimatas"

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2016. You cannot join it, but the record below documents what was studied.

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