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Oleogel-S10 Versus Standard of Care in Healing of Grade 2a Burn Wounds

NCT01657292 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 61

Last updated 2015-09-28

Study results available
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Summary

The main goal of this phase III clinical trial is to show safety and efficacy of Oleogel-S10 in the acceleration of wound healing of grade 2a burn wounds.

Conditions

  • Burns

Interventions

DRUG

Oleogel-S10 ointment

Intraindividual comparison: One randomly assigned wound half is treated with Oleogel-S10 ointment and fatty gauze wound dressing

DEVICE

Octenilin® wound gel

Intraindividual comparison: The other wound half is treated with Octenilin® wound gel and fatty gauze wound dressing

Sponsors & Collaborators

  • Birken AG

    lead INDUSTRY

Principal Investigators

  • Bernd Hartmann, Dr. · Trauma Hospital Berlin, Warener Str. 7, 12683 Berlin, Germany

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-08-31
Primary Completion
2013-07-31
Completion
2014-07-31

Countries

  • Germany
  • Sweden
  • Switzerland
  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01657292 on ClinicalTrials.gov