BurnsPhase 3NCT01657292
Oleogel-S10 Versus Standard of Care in Healing of Grade 2a Burn Wounds
A Phase 3 study testing Oleogel-S10 ointment and Octenilin® wound gel in people with Burns, run by Birken AG at 9 sites in 4 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Burns
- What is being tested?
- Oleogel-S10 ointment and Octenilin® wound gel
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 61 participants
- Where
- 9 sitesin 4 countries
- Study dates
- Aug 2012to Jul 2014
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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))
Who cannot join
- 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.
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- 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
Trial locations and contacts
9 sites in 4 countries.
9 sites in 4 countries
Germany3 sites
Unfallkrankenhaus Berlin
Berlin
Berufsgenossenschaftliches Universitätsklinikum Bergmannsheil
Bochum
Universitätsklinikum Schleswig-Holstein
Lübeck
United Kingdom3 sites
University Hospitals Birmingham NHS Foundation Trust
Birmingham
Broomfield Hospital
Chelmsford
Queen Victoria Hospital
East Grinstead
Sweden2 sites
Linköping University Hospital
Linköping
University Hospital
Uppsala
About this study
Official title: Open, Blindly Evaluated, Prospective, Controlled, Randomized, Multicenter Phase III Clinical Trial to Compare Intra-individually the Efficacy and Tolerance of Oleogel-S10 Versus Standard of Care in Accelerating the Healing of Grade 2a Partial-Thickness Burn Wounds
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.
Read the detailed description
Oleogel-S10 has shown efficacy and was well tolerated in previous clinical trials in patients with skin lesions. Especially the results in the split-thickness skin graft donor site, which is regarded as an excellent model for any kind of superficial wounds in human skin, suggest that Oleogel-S10 should be efficacious and safe in treatment of grade 2a burns.
The present Phase III clinical trial in grade 2a burns is initiated in order to measure the wound healing progress applying objective methods, i.e., the time to healing and the grade of epithelialization of the wound.
In this study, grade 2a burn wounds are separated into two halves: Following wound cleaning and disinfection, wounds are separated into two wound halves. Randomly assigned, one wound half receives Oleogel-S10 ointment, the other wound half standard of care treatment.
Wound healing progress is documented by photos which are assessed by expert reviewers blinded to the treatment of the wound halves.
- Conditions
- Burns
- Being tested
- Oleogel-S10 ointment, Octenilin® wound gel
- Keywords
- Wound healing, Burn wound, Superficial partial-thickness burn wound, Grade 2a burn wounds, Time to wound closure
- Medical subject headings
- Burns
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oleogel-S10 ointmentDrug
Intraindividual comparison: One randomly assigned wound half is treated with Oleogel-S10 ointment and fatty gauze wound dressing
Octenilin® wound gelDevice
Also called Contains Octenidine
Intraindividual comparison: The other wound half is treated with Octenilin® wound gel and fatty gauze wound dressing
| Study group | Role | What they receive |
|---|---|---|
| Oleogel-S10 ointment | Experimental | Intra-individual comparison. Oleogel-S10 ointment is administered to one randomly assigned wound half. Receives: Drug: Oleogel-S10 ointment; Device: Octenilin® wound gel |
| Octenilin® wound gel | Other | Intraindividual comparison: The other wound half receives disinfectant Octenilin® wound gel. Receives: Drug: Oleogel-S10 ointment; Device: Octenilin® wound gel |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: 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
Measured: 2 to 3 weeks
Percentage of Patients With Wound Closure at Different Time Points
Measured: 2 to 3 weeks
Percentage of Wound Epithelialization at Different Time Points as Assessed by the Investigator
Measured: 2 to 3 weeks
Likert Scale Rating of Efficacy (Evaluated by Both the Investigators and Patients)
By direct comparison of the separate simultaneous treatments for the two wound halves, patients and investigators, respectively, are asked to grade the efficacy of Oleogel-S10 Versus Standard of Care on a questionnaire with a 5-point graded visual analogue scale
Measured: 2 to 3 weeks
Cosmetic Outcome After 3 and 12 Months After Burn Accident, in Relation to Texture, Redness, Growth of Hair and Pigmentation, Based on Blinded Photo Evaluation
Measured: 3 and 12 months
Likert Scale Rating of Tolerance (Evaluated by Both the Investigators and Patients)
By direct comparison of the separate simultaneous treatments for the two wound halves, patients and investigators, respectively, are asked to provide their opinion on the tolerance of Oleogel-S10 Versus Standard of Care on a questionnaire with a 5-point graded visual analogue scale
Measured: 2 to 3 weeks
PK Data: Systemic Presence/Concentration of Betulin in Blood Plasma Samples
Measured: 2 to 3 weeks
Microbial Colonization of the Wound Halves
Measured: 2 to 3 weeks
Assessment of Adverse Events
Measured: 2 to 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2012 (estimated)
- Study startAug 2012
- Primary completionJul 2013
- Study completionJul 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for BurnsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 61 participants (actual)
Sponsor and investigators
- Lead sponsor
- Birken AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bernd Hartmann, Dr., Principal investigator, Trauma Hospital Berlin, Warener Str. 7, 12683 Berlin, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01657292
- Sponsor's protocol ID
- BBW-11
- Other IDs
- 2012-000362-38
- Status last verified
- Aug 2015
- First submitted
- 29 Jul 2012
- Last updated
- 28 Sep 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open, Blindly Evaluated, Prospective, Controlled, Randomized, Multicenter Phase III Clinical Trial to Compare Intra-individually the Efficacy and Tolerance of Oleogel-S10 Versus Standard of Care in Accelerating the Healing of Grade 2a Partial-Thickness Burn Wounds
- ClinicalTrials.gov ID
- NCT01657292
- Acronym / sponsor ID
- BBW-11
- Conditions
- Burns
- Keywords
- Wound healing, Burn wound, Superficial partial-thickness burn wound, Grade 2a burn wounds, Time to wound closure
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 61 participants (actual)
- Lead sponsor
- Birken AGIndustry (pharma, biotech, devices)
- Study start
- Aug 2012
- Primary completion
- Jul 2013 (actual)
- Study completion
- Jul 2014 (actual)
- First posted
- 6 Aug 2012 (estimated)
- Results
- Posted 28 Sep 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Oleogel-S10 has shown efficacy and was well tolerated in previous clinical trials in patients with skin lesions. Especially the results in the split-thickness skin graft donor site, which is regarded as an excellent model for any kind of superficial wounds in human skin, suggest that Oleogel-S10 should be efficacious and safe in treatment of grade 2a burns.
The present Phase III clinical trial in grade 2a burns is initiated in order to measure the wound healing progress applying objective methods, i.e., the time to healing and the grade of epithelialization of the wound.
In this study, grade 2a burn wounds are separated into two halves: Following wound cleaning and disinfection, wounds are separated into two wound halves. Randomly assigned, one wound half receives Oleogel-S10 ointment, the other wound half standard of care treatment.
Wound healing progress is documented by photos which are assessed by expert reviewers blinded to the treatment of the wound halves.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Oleogel-S10 ointment | Experimental | Drug: Oleogel-S10 ointment, Device: Octenilin® wound gelIntra-individual comparison. Oleogel-S10 ointment is administered to one randomly assigned wound half. |
| Octenilin® wound gel | Other | Drug: Oleogel-S10 ointment, Device: Octenilin® wound gelIntraindividual comparison: The other wound half receives disinfectant Octenilin® wound gel. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (13 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Oleogel-S10 ointmentIntraindividual comparison: One randomly assigned wound half is treated with Oleogel-S10 ointment and fatty gauze wound dressing | Drug | Octenilin® wound gel, Oleogel-S10 ointment |
| Octenilin® wound gelAlso: Contains OctenidineIntraindividual comparison: The other wound half is treated with Octenilin® wound gel and fatty gauze wound dressing | Device | Octenilin® wound gel, Oleogel-S10 ointment |
Primary outcome
Percentage of Patients With Earlier Healing of the Wound Half Treated With Oleogel-S10 Compared to the Wound Half Receiving Standard of Care
Time frame: 2 to 3 weeks
Photo-based evaluation by independent experts blinded to the treatment regime.
10 secondary outcomes
Intra-individual Difference in Time to Wound Closure Between Wound Halves, Either Treated With Oleogel-S10 or Treated With Standard of Care
Time frame: 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
Time frame: 2 to 3 weeks
Percentage of Patients With Wound Closure at Different Time Points
Time frame: 2 to 3 weeks
Percentage of Wound Epithelialization at Different Time Points as Assessed by the Investigator
Time frame: 2 to 3 weeks
Likert Scale Rating of Efficacy (Evaluated by Both the Investigators and Patients)
Time frame: 2 to 3 weeks
Cosmetic Outcome After 3 and 12 Months After Burn Accident, in Relation to Texture, Redness, Growth of Hair and Pigmentation, Based on Blinded Photo Evaluation
Time frame: 3 and 12 months
Likert Scale Rating of Tolerance (Evaluated by Both the Investigators and Patients)
Time frame: 2 to 3 weeks
PK Data: Systemic Presence/Concentration of Betulin in Blood Plasma Samples
Time frame: 2 to 3 weeks
Microbial Colonization of the Wound Halves
Time frame: 2 to 3 weeks
Assessment of Adverse Events
Time frame: 2 to 3 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bernd Hartmann, Dr. principal investigator
Trauma Hospital Berlin, Warener Str. 7, 12683 Berlin, Germany
9 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Oleogel-S10 ointment and Octenilin® wound gel in people with Burns, run by Birken AG at 9 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Sep 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in Germany, United Kingdom, Sweden, Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 28 Sep 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Patients With Earlier Healing of the Wound Half Treated With Oleogel-S10 Compared to the Wound Half Receiving Standard of Care (time frame: 2 to 3 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Sep 2015.