NCT01657292

Brief 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.

Trial Health

90
On Track

Trial Health Score

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

Enrollment
61

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Aug 2012

Geographic Reach
4 countries

9 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

July 29, 2012

Completed
3 days until next milestone

Study Start

First participant enrolled

August 1, 2012

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 6, 2012

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2013

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2014

Completed
1.2 years until next milestone

Results Posted

Study results publicly available

September 28, 2015

Completed
Last Updated

September 28, 2015

Status Verified

August 1, 2015

Enrollment Period

11 months

First QC Date

July 29, 2012

Results QC Date

July 31, 2015

Last Update Submit

August 28, 2015

Conditions

Burns

Keywords

Wound healingBurn woundSuperficial partial-thickness burn woundGrade 2a burn woundsTime to wound closure

Outcome Measures

Primary Outcomes (1)

  • Percentage of Patients With Earlier Healing of the Wound Half Treated With Oleogel-S10 Compared to the Wound Half Receiving Standard of Care

    Photo-based evaluation by independent experts blinded to the treatment regime.

    2 to 3 weeks

Secondary Outcomes (10)

  • Intra-individual Difference in Time to Wound Closure Between Wound Halves, Either Treated With Oleogel-S10 or Treated With Standard of Care

    2 to 3 weeks

  • Time From Study Start After Burn Accident Until Wound Closure is Achieved Separately for Wound Halves Treated With Oleogel-S10 vs. Standard of Care

    2 to 3 weeks

  • Percentage of Patients With Wound Closure at Different Time Points

    2 to 3 weeks

  • Percentage of Wound Epithelialization at Different Time Points as Assessed by the Investigator

    2 to 3 weeks

  • Likert Scale Rating of Efficacy (Evaluated by Both the Investigators and Patients)

    2 to 3 weeks

  • +5 more secondary outcomes

Study Arms (2)

Oleogel-S10 ointment

EXPERIMENTAL

Intra-individual comparison. Oleogel-S10 ointment is administered to one randomly assigned wound half.

Drug: Oleogel-S10 ointmentDevice: Octenilin® wound gel

Octenilin® wound gel

OTHER

Intraindividual comparison: The other wound half receives disinfectant Octenilin® wound gel.

Drug: Oleogel-S10 ointmentDevice: Octenilin® wound gel

Interventions

Oleogel-S10 ointmentDRUG

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

Octenilin® wound gelOleogel-S10 ointment
Octenilin® wound gelDEVICE

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

Also known as: Contains Octenidine
Octenilin® wound gelOleogel-S10 ointment

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients at least 18 years old who have provided written informed consent.
  • Presenting with acute grade 2a burn wounds (as graded by an expert surgeon assisted by LDI or a multispectral imaging system) within 48 hours after injury.
  • Burn wound caused by fire burn, heat burn or scalding.
  • Burn patients with grade 2a burn wounds between 80 cm2 and less than 25% of their TBSA (alternatively, 2 comparable wounds with size more than 40 cm2 each and less than 12.5% of the TBSA each are allowed).
  • Patient is able to understand the Informed Consent Form provided and is prepared to comply with all study requirements, including the following: Visiting the trial site for wound dressing changes at least every second day (if patient is not hospitalized) and photo documentation until full wound closure or until the Investigator decides to change medication and/or treatment after day 21 after start of treatment
  • Willing to perform all necessary wound dressing changes at the trial site. Also the patient needs to agree to return to site for 3 and 12 months follow-up visits.
  • Women of childbearing potential must apply highly effective method of birth control (failure rate less than 1% per year when used consistently and correctly (e.g., implants, injectables, combined oral contraceptives, some intrauterine contraceptive devices (IUDs), sexual abstinence, or a vasectomized partner))

You may not qualify if:

  • Suffering from chemical burns, or electrical burns or sunburns
  • Having already received treatment for their burn with silver sulfadiazine (obscures photographic wound evaluation).
  • Positive blood culture after the burn.
  • Diseases or conditions that could, in the opinion of the Investigator, interfere with the assessment of safety, tolerance or efficacy.
  • A skin disorder that is chronic or currently active and which the Investigator considers will adversely affect the healing of the acute wounds or involves the areas to be examined in this trial.
  • A history of clinically significant hypersensitivity to any of the drugs or surgical dressings to be used in this trial.
  • Known multiple allergic disorders.
  • Taking, or have taken, any investigational drugs within 3 months prior to the screening visit.
  • Pregnant or breast feeding women are not allowed to participate in the study.
  • Inappropriate to participate in the study, for any reason, in the opinion of the Investigator.
  • Mental incapacity or language barriers precluding adequate understanding or co-operation or willingness to follow study procedures.
  • Previous participation in this study.
  • Employee at the investigational site, relative or spouse of the Investigator

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (9)

Unfallkrankenhaus Berlin

Berlin, Germany

Location

Berufsgenossenschaftliches Universitätsklinikum Bergmannsheil

Bochum, Germany

Location

Universitätsklinikum Schleswig-Holstein

Lübeck, Germany

Location

Linköping University Hospital

Linköping, Sweden

Location

University Hospital

Uppsala, Sweden

Location

Centre Hospitalier Universitaire Vaudois

Lausanne, Switzerland

Location

University Hospitals Birmingham NHS Foundation Trust

Birmingham, United Kingdom

Location

Broomfield Hospital

Chelmsford, United Kingdom

Location

Queen Victoria Hospital

East Grinstead, United Kingdom

Location

MeSH Terms

Conditions

Burns

Condition Hierarchy (Ancestors)

Wounds and Injuries

Results Point of Contact

Title
Head of pharmaceutical development
Organization
Birken AG
t.zahn@birken.eu
+49 7233 97490

Study Officials

  • Bernd Hartmann, Dr.

    Trauma Hospital Berlin, Warener Str. 7, 12683 Berlin, Germany

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 29, 2012

First Posted

August 6, 2012

Study Start

August 1, 2012

Primary Completion

July 1, 2013

Study Completion

July 1, 2014

Last Updated

September 28, 2015

Results First Posted

September 28, 2015

Record last verified: 2015-08

Locations

CH(1)GB(3)DE(3)SE(2)