NCT01704950

Brief 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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
52

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Feb 2013

Typical duration for all trials

Geographic Reach
4 countries

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 9, 2012

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 12, 2012

Completed
4 months until next milestone

Study Start

First participant enrolled

February 1, 2013

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2014

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2015

Completed
Last Updated

February 25, 2016

Status Verified

February 1, 2016

Enrollment Period

1.4 years

First QC Date

October 9, 2012

Last Update Submit

February 24, 2016

Conditions

Traumatic WoundReconstruction Wound

Outcome Measures

Primary Outcomes (1)

  • Rate of graft take

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

    Day 15 after the surgery

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Global population

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

St Josef Hospital

Bochum, 44791, Germany

Location

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

Athens, 11527, Greece

Location

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

Udine, 33100, Italy

Location

Queen Elizabeth Hospital - Burn and Plastic Surgery

Birmingham, B15 2WB, United Kingdom

Location

Study Officials

  • Stefanos Papadopoulos

    General State Hospital of Athens, "G. Gennimatas"

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 9, 2012

First Posted

October 12, 2012

Study Start

February 1, 2013

Primary Completion

July 1, 2014

Study Completion

August 1, 2015

Last Updated

February 25, 2016

Record last verified: 2016-02

Locations

DE(1)GR(1)GB(1)IT(1)