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Oleogel-S10 in Wound Healing of Split-Thickness Skin Graft Donor Sites (BSH-12)

NCT01657305 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 107

Last updated 2018-01-23

Study results available
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Summary

The main purpose of this phase III clinical trial was to compare intra-individually the efficacy, safety and tolerability of Oleogel-S10 and non-adhesive wound dressing versus non-adhesive wound dressing only in accelerating the wound healing of Split-Thickness Skin Graft (STSG) donor sites.

Conditions

  • Wounds

Interventions

DRUG

Oleogel-S10, non-adhesive wound dressing

1 cm or 100 mg Oleogel-S10 per cm2 wound area (corresponds to thickness of approximately 1 mm or 0.04 inch) every 3 to 4 days until 95% epithelialization of the wound or end of treatment at Day 28.

DEVICE

Non-adhesive wound dressing only

Soft silicone faced polyurethane foam dressing such as Mepilex® only every 3 to 4 days until 95% epithelialization of the wound or end of treatment at Day 28.

Sponsors & Collaborators

  • Birken AG

    lead INDUSTRY

Principal Investigators

  • Hans Robert Metelmann, Prof · Universitätsmedizin Greifswald MKG-Chirurgie/Plastische Operationen

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-08-31
Primary Completion
2013-08-31
Completion
2014-09-30

Countries

  • Austria
  • Bulgaria
  • Czechia
  • Finland
  • Germany
  • Poland

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 NCT01657305 on ClinicalTrials.gov