Oleogel-S10 in Wound Healing of Split-Thickness Skin Graft Donor Sites - Full Text View

Purpose

The main purpose of this phase III clinical trial is to show safety and efficacy of Oleogel-S10 in the acceleration of Split-Thickness Skin Graft Donor Sites.

Condition	Intervention	Phase
Wounds	Drug: Oleogel-S10 ointment and non-adhesive wound dressing Device: Non-adhesive wound dressing alone	Phase 3

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
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 Wound Healing of Split Thickness Skin Graft Donor Sites

Further study details as provided by Birken AG:

Primary Outcome Measures:

Intra-individual difference in time to wound closure [ Time Frame: 2 to 4 weeks ] [ Designated as safety issue: No ]
Intra-individual difference in time to wound closure between wound halves, either treated with Oleogel-S10 and non-adhesive wound dressing or treated with non-adhesive wound dressing alone

Secondary Outcome Measures:

Time from surgery until wound closure is achieved [ Time Frame: 2 to 4 weeks ] [ Designated as safety issue: No ]
Time from surgery until wound closure is achieved, separately for wound halves treated with Oleogel-S10 and non-adhesive wound dressing vs. non-adhesive wound dressing alone
Percentage of patients with earlier healing [ Time Frame: 2 to 4 weeks ] [ Designated as safety issue: No ]
Percentage of patients with earlier healing of wound area treated with Oleogel-S10 and non-adhesive wound dressing compared to non-adhesive wound dressing alone
Percentage of patients with wound closure at different time points [ Time Frame: 2 to 4 weeks ] [ Designated as safety issue: No ]
Percentage of wound epithelialization at different time points as assessed by the Investigator [ Time Frame: 2 to 4 weeks ] [ Designated as safety issue: No ]
Likert scale rating of efficacy [ Time Frame: 2 to 4 weeks ] [ Designated as safety issue: No ]
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 surgery [ Time Frame: 3-12 month ] [ Designated as safety issue: No ]
Likert scale rating of tolerance [ Time Frame: 2 to 4 weeks ] [ Designated as safety issue: Yes ]
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 [ Time Frame: 2 to 4 weeks ] [ Designated as safety issue: Yes ]
Systemic presence/concentration of betulin in blood plasma samples
Adverse events [ Time Frame: as required ] [ Designated as safety issue: Yes ]
Assessment of adverse events

Estimated Enrollment:	105
Study Start Date:	August 2012
Estimated Study Completion Date:	March 2014
Estimated Primary Completion Date:	January 2014 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Oleogel-S10 ointment Intraindividual comparison: Oleogel-S10 ointment and non-adhesive wound dressing applied to one randomly assigned wound half	Drug: Oleogel-S10 ointment and non-adhesive wound dressing One randomly assigned wound half is treated with Oleogel-S10 and non-adhesive wound dressing
Non-adhesive wound dressing Intra-individual comparison: Non-adhesive wound dressing alone is administered to the other wound half. Wound dressings without pharmacological intervention represent standard of care in treatment of split-thickness skin graft donor sites	Device: Non-adhesive wound dressing alone The other wound half is treated with non-adhesive wound dressing alone.

Detailed Description:

Oleogel-S10 has shown efficacy and was well tolerated in previous clinical trials in patients with skin lesions. Especially the results in a previous study with split-thickness skin graft donor site suggest that Oleogel-S10 should be efficacious and safe in the treatment of superficial wounds.

The present phase III clinical trial again in grade split-thickness skin graft donor sites is initiated in order to demonstrate the measure of wound healing progress applying objective methods, i.e., the time to healing and the grade of epithelialization of the wound.

In this study, split-thickness skin graft donor sites 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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Presenting a split-thickness skin graft donor site wound with a minimum size of 15 cm2 and with a minimum width of 3 cm.
Patient is able to understand the ICF provided and is prepared to comply with all study requirements, including the following: Visiting the trial site for wound dressing change and photo documentation every third or fourth day until both wound halves are closed (but no longer than 28 days after surgery).
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:

Diseases or conditions that could, in the opinion of the Investigator, interfere with the assessment of safety 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, surgical dressings or excipients 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 the Informed consent form 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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01657305

Contacts

Contact: Kathrin Schuth

k.schuth@birken.eu

Locations

Austria
Medical University of Graz	Not yet recruiting
Graz, Austria
Landesklinik für Dermatologie	Not yet recruiting
Salzburg, Austria
Medical University Vienna	Not yet recruiting
Vienna, Austria
Bulgaria
University Multiprofile Hospital for Active Treatment-"Dr. Georgi Stranski" EAD	Not yet recruiting
Pleven, Bulgaria
University Multiprofile Hospital for Active Treatment "Saint George"	Not yet recruiting
Plovdiv, Bulgaria
Multiprofile Hospital for Active Treatment- Russe	Not yet recruiting
Russe, Bulgaria
University Multiprofile Hospital for Active Treatment and Emergency Medicine "N.I.Pirogov"	Not yet recruiting
Sofia, Bulgaria
University Multiprofile Hospital for Active Treatment-Varna at MMA-Sofia	Not yet recruiting
Varna, Bulgaria
Czech Republic
Universtity Hospital Brno	Recruiting
Brno, Czech Republic
University Hospital Olomouc	Recruiting
Olomouc, Czech Republic
Finland
Päijät-Hämeen keskussairaala	Recruiting
Lahti, Finland
Satakunnan keskussairaala	Recruiting
Pori, Finland
Germany
University Hospital RWTH Aachen	Not yet recruiting
Aachen, Germany
Trauma Hospital	Recruiting
Berlin, Germany
Charité	Not yet recruiting
Berlin, Germany
University Hospital	Recruiting
Düsseldorf, Germany
Essen University Hospital	Recruiting
Essen, Germany
University Hospital	Recruiting
Frankfurt, Germany
University Medical Center	Recruiting
Freiburg, Germany
University Medicine Greifswald	Recruiting
Greifswald, Germany
HELIOS Clinic	Recruiting
Krefeld, Germany
University Medical Center	Recruiting
Mainz, Germany
Klinikum rechts der Isar	Recruiting
München, Germany
Poland
Univesity Hospital Gdansk	Not yet recruiting
Gdansk, Poland
Samodzelny Publiczny Szpital Kliniczny Nr. 1	Not yet recruiting
Lublin, Poland

Sponsors and Collaborators

Birken AG

Investigators

Principal Investigator:

Hans Robert Metelmann, Prof. Dr. med. Dr. med. dent.

Universitätsmedizin Greifswald MKG-Chirurgie/Plastische Operationen

More Information

No publications provided

Responsible Party:	Birken AG
ClinicalTrials.gov Identifier:	NCT01657305 History of Changes
Other Study ID Numbers:	BSH-12, 2012-000777-23
Study First Received:	July 29, 2012
Last Updated:	May 27, 2013
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices Czech Republic: State Institute for Drug Control Finland: Finnish Medicines Agency Poland: National Institute of Medicines

Keywords provided by Birken AG:

Split-Thickness Skin Graft Donor Site
Split-thickness skin graft
STSG
Wound healing

Skin grafting
Superficial wound
Partial-thickness wound
Time to wound closure

ClinicalTrials.gov processed this record on June 18, 2013