Oleogel-S10 Versus Standard of Care in Healing of Grade 2a Burn Wounds

Burns Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01657292
• Other study ID #: BBW-11
• Secondary ID: 2012-000362-38
• Status: Completed
• Phase: Phase 3
• First received: July 29, 2012
• Last updated: August 28, 2015
• Start date: August 2012
• Est. completion date: July 2014

Study information

• Verified date: August 2015
• Source: Birken AG
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical DevicesSweden: Medical Products AgencySwitzerland: SwissmedicUnited Kingdom: Medicines and Healthcare Products Regulatory Agency
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 61
• Est. completion date: July 2014
• Est. primary completion date: July 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Burns

Intervention

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

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

Locations

Country	Name	City	State
Germany	Unfallkrankenhaus Berlin	Berlin
Germany	Berufsgenossenschaftliches Universitätsklinikum Bergmannsheil	Bochum
Germany	Universitätsklinikum Schleswig-Holstein	Lübeck
Sweden	Linköping University Hospital	Linköping
Sweden	University Hospital	Uppsala
Switzerland	Centre Hospitalier Universitaire Vaudois	Lausanne
United Kingdom	University Hospitals Birmingham NHS Foundation Trust	Birmingham
United Kingdom	Broomfield Hospital	Chelmsford
United Kingdom	Queen Victoria Hospital	East Grinstead

Sponsors (1)

Lead Sponsor	Collaborator
Birken AG

Countries where clinical trial is conducted

Germany,  Sweden,  Switzerland,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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.	2 to 3 weeks	No
Secondary	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	No
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		2 to 3 weeks	No
Secondary	Percentage of Patients With Wound Closure at Different Time Points		2 to 3 weeks	No
Secondary	Percentage of Wound Epithelialization at Different Time Points as Assessed by the Investigator		2 to 3 weeks	No
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	2 to 3 weeks	No
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		3 and 12 months	No
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	2 to 3 weeks	Yes
Secondary	PK Data: Systemic Presence/Concentration of Betulin in Blood Plasma Samples		2 to 3 weeks	Yes
Secondary	Microbial Colonization of the Wound Halves		2 to 3 weeks	Yes
Secondary	Assessment of Adverse Events		2 to 3 weeks	Yes