Back to resultsOleogel-S10 Versus Standard of Care in Healing of Grade 2a Burn Wounds
Primary Purpose
Burns
Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Oleogel-S10 ointment
Octenilin® wound gel
Sponsored by
About this trial
This is an interventional treatment trial for Burns focused on measuring Wound healing, Burn wound, Superficial partial-thickness burn wound, Grade 2a burn wounds, Time to wound closure
Eligibility Criteria
Inclusion Criteria:
- 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))
Exclusion Criteria:
- 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
Sites / Locations
- Unfallkrankenhaus Berlin
- Berufsgenossenschaftliches Universitätsklinikum Bergmannsheil
- Universitätsklinikum Schleswig-Holstein
- Linköping University Hospital
- University Hospital
- Centre Hospitalier Universitaire Vaudois
- University Hospitals Birmingham NHS Foundation Trust
- Broomfield Hospital
- Queen Victoria Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Other
Arm Label
Oleogel-S10 ointment
Octenilin® wound gel
Arm Description
Intra-individual comparison. Oleogel-S10 ointment is administered to one randomly assigned wound half.
Intraindividual comparison: The other wound half receives disinfectant Octenilin® wound gel.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Intra-individual Difference in Time to Wound Closure Between Wound Halves, Either Treated With Oleogel-S10 or Treated With Standard of Care
Time From Study Start After Burn Accident Until Wound Closure is Achieved Separately for Wound Halves Treated With Oleogel-S10 vs. Standard of Care
Percentage of Patients With Wound Closure at Different Time Points
Percentage of Wound Epithelialization at Different Time Points as Assessed by the Investigator
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
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
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
PK Data: Systemic Presence/Concentration of Betulin in Blood Plasma Samples
Microbial Colonization of the Wound Halves
Assessment of Adverse Events
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01657292
Brief Title
Oleogel-S10 Versus Standard of Care in Healing of Grade 2a Burn Wounds
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
Study Type
Interventional
2. Study Status
Record Verification Date
August 2015
Overall Recruitment Status
Completed
Study Start Date
August 2012 (undefined)
Primary Completion Date
July 2013 (Actual)
Study Completion Date
July 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Birken AG
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Burns
Keywords
Wound healing, Burn wound, Superficial partial-thickness burn wound, Grade 2a burn wounds, Time to wound closure
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
61 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Oleogel-S10 ointment
Arm Type
Experimental
Arm Description
Intra-individual comparison. Oleogel-S10 ointment is administered to one randomly assigned wound half.
Arm Title
Octenilin® wound gel
Arm Type
Other
Arm Description
Intraindividual comparison: The other wound half receives disinfectant Octenilin® wound gel.
Intervention Type
Drug
Intervention Name(s)
Oleogel-S10 ointment
Intervention Description
Intraindividual comparison: One randomly assigned wound half is treated with Oleogel-S10 ointment and fatty gauze wound dressing
Intervention Type
Device
Intervention Name(s)
Octenilin® wound gel
Other Intervention Name(s)
Contains Octenidine
Intervention Description
Intraindividual comparison: The other wound half is treated with Octenilin® wound gel and fatty gauze wound dressing
Primary Outcome Measure Information:
Title
Percentage of Patients With Earlier Healing of the Wound Half Treated With Oleogel-S10 Compared to the Wound Half Receiving Standard of Care
Description
Photo-based evaluation by independent experts blinded to the treatment regime.
Time Frame
2 to 3 weeks
Secondary Outcome Measure Information:
Title
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
Title
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
Title
Percentage of Patients With Wound Closure at Different Time Points
Time Frame
2 to 3 weeks
Title
Percentage of Wound Epithelialization at Different Time Points as Assessed by the Investigator
Time Frame
2 to 3 weeks
Title
Likert Scale Rating of Efficacy (Evaluated by Both the Investigators and Patients)
Description
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
Time Frame
2 to 3 weeks
Title
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
Title
Likert Scale Rating of Tolerance (Evaluated by Both the Investigators and Patients)
Description
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
Time Frame
2 to 3 weeks
Title
PK Data: Systemic Presence/Concentration of Betulin in Blood Plasma Samples
Time Frame
2 to 3 weeks
Title
Microbial Colonization of the Wound Halves
Time Frame
2 to 3 weeks
Title
Assessment of Adverse Events
Time Frame
2 to 3 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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))
Exclusion Criteria:
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bernd Hartmann, Dr.
Organizational Affiliation
Trauma Hospital Berlin, Warener Str. 7, 12683 Berlin, Germany
Official's Role
Principal Investigator
Facility Information:
Facility Name
Unfallkrankenhaus Berlin
City
Berlin
Country
Germany
Facility Name
Berufsgenossenschaftliches Universitätsklinikum Bergmannsheil
City
Bochum
Country
Germany
Facility Name
Universitätsklinikum Schleswig-Holstein
City
Lübeck
Country
Germany
Facility Name
Linköping University Hospital
City
Linköping
Country
Sweden
Facility Name
University Hospital
City
Uppsala
Country
Sweden
Facility Name
Centre Hospitalier Universitaire Vaudois
City
Lausanne
Country
Switzerland
Facility Name
University Hospitals Birmingham NHS Foundation Trust
City
Birmingham
Country
United Kingdom
Facility Name
Broomfield Hospital
City
Chelmsford
Country
United Kingdom
Facility Name
Queen Victoria Hospital
City
East Grinstead
Country
United Kingdom
12. IPD Sharing Statement
Learn more about this trial
Oleogel-S10 Versus Standard of Care in Healing of Grade 2a Burn Wounds
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