Burns
Conditions
Keywords
Wound healing, Burn wound, Superficial partial-thickness burn wound, Grade 2a burn wounds, Time to wound closure
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.
Interventions
DRUGOleogel-S10 ointment
Intraindividual comparison: One randomly assigned wound half is treated with Oleogel-S10 ointment and fatty gauze wound dressing
DEVICEOctenilin® wound gel
Intraindividual comparison: The other wound half is treated with Octenilin® wound gel and fatty gauze wound dressing
Sponsors
Birken AG
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Patients With Earlier Healing of the Wound Half Treated With Oleogel-S10 Compared to the Wound Half Receiving Standard of Care | 2 to 3 weeks | Photo-based evaluation by independent experts blinded to the treatment regime. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | 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 |
| 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 | — |
| Likert Scale Rating of Tolerance (Evaluated by Both the Investigators and Patients) | 2 to 3 weeks | 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 | 2 to 3 weeks | — |
| Microbial Colonization of the Wound Halves | 2 to 3 weeks | — |
| Assessment of Adverse Events | 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 | 3 and 12 months | — |
Countries
Germany, Sweden, Switzerland, United Kingdom
Participant flow
Recruitment details
Study participants were enrolled from 31-Aug-2012 to 10-Jul-2013, in 10 clinical centres in 4 countries: Germany (4 centers), Uk (3 centers), Sweden (2 centers), and Switzerland (1 center).
Pre-assignment details
66 patients were screened of which 5 violated eligibility criteria and thus 61 subjects were treated.
Participants by arm
| Arm | Count |
|---|---|
| Entire Study Population All patients treated with Oleogel-S10 and Octenilin® wound gel. | 61 |
| Total | 61 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 6 |
| Overall Study | Change of therapy | 1 |
| Overall Study | Violation of eligibility criteria | 1 |
| Overall Study | Withdrawal by Subject | 2 |
Baseline characteristics
| Characteristic | Entire Study Population |
|---|---|
| Age, Categorical <=18 years | 1 Participants |
| Age, Categorical >=65 years | 6 Participants |
| Age, Categorical Between 18 and 65 years | 54 Participants |
| Age, Continuous | 41 years |
| Region of Enrollment Germany | 26 participants |
| Region of Enrollment Sweden | 3 participants |
| Region of Enrollment Switzerland | 4 participants |
| Region of Enrollment United Kingdom | 28 participants |
| Sex: Female, Male Female | 19 Participants |
| Sex: Female, Male Male | 42 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 61 | 0 / 61 | 0 / 61 | 0 / 61 |
| serious Total, serious adverse events | 2 / 61 | 1 / 61 | 1 / 61 | 4 / 61 |
Outcome results
Primary
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.
Time frame: 2 to 3 weeks
Population: The analysis included all patients who were treated at least once with Oleogel-S10 or Octenilin® wound gel (as randomised) and for whom a difference in wound healing between the treatment was observed.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Entire Study Population | Percentage of Patients With Earlier Healing of the Wound Half Treated With Oleogel-S10 Compared to the Wound Half Receiving Standard of Care | 85.7 percentage of patients |
Comparison: All patients received both treatments and treatments were intra-individually compared.~Hypotheses tested: H0: s0 ≤0.5 and H1: s0 \>0.5 (with s0=rate of superiority of Oleogel-S10).p-value: <0.0001Binomial test
Secondary
Assessment of Adverse Events
Time frame: 2 to 3 weeks
Secondary
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
Secondary
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
Secondary
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
Time frame: 2 to 3 weeks
Secondary
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
Time frame: 2 to 3 weeks
Secondary
Microbial Colonization of the Wound Halves
Time frame: 2 to 3 weeks
Secondary
Percentage of Patients With Wound Closure at Different Time Points
Time frame: 2 to 3 weeks
Secondary
Percentage of Wound Epithelialization at Different Time Points as Assessed by the Investigator
Time frame: 2 to 3 weeks
Secondary
PK Data: Systemic Presence/Concentration of Betulin in Blood Plasma Samples
Time frame: 2 to 3 weeks
Secondary
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