Clinical trial NCT01657305: Oleogel-S10 in Wound Healing of Split-Thickness Skin Graft Donor Sites (BSH-12)
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Wounds
Keywords: Split-Thickness Skin Graft (STSG) donor site
Split-thickness skin graft
STSG
Wound healing
Skin grafting
Superficial wound
Partial-thickness wound
Time to wound closure
Lead sponsor: Amryt Pharma
Sponsor class: INDUSTRY
First posted: 2012-08-06
Enrollment: 107
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The main purpose of this phase III clinical trial was to compare intra-individually the efficacy, safety and tolerability of Oleogel-S10 and non-adhesive wound dressing versus non-adhesive wound dressing only in accelerating the wound healing of Split-Thickness Skin Graft (STSG) donor sites.

Detailed description: Oleogel-S10 has shown efficacy and was well tolerated in previous clinical trials in participants with skin lesions. Especially the results in a previous study with STSG donor sites suggested that Oleogel-S10 should be efficacious and safe in the treatment of superficial wounds.

The present phase III clinical trial in STSG donor sites was initiated to demonstrate wound healing progress, i.e., the time to healing and the grade of epithelialization of the wound.

In this study, STSG donor sites were separated into 2 wound halves. Randomly assigned, 1 wound half was treated with Oleogel-S10 and non-adhesive wound dressing, the other wound half with non-adhesive wound dressing only (standard of care).

Wound healing progress was documented by photos which were assessed by expert reviewers blind to the treatment of the wound halves.

Eligibility 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 Informed Consent Form (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.

Primary outcomes:
measure: Intra-individual Difference in Time to Wound Closure
timeFrame: up to 4 weeks
Secondary outcomes:
measure: Time From Surgery Until Wound Closure is Achieved
timeFrame: up to 4 weeks
measure: Percentage of Participants With Earlier Healing
timeFrame: up to 4 weeks
measure: Percentage of Participants With Wound Closure at Different Time Points
timeFrame: up to 4 weeks
measure: Percentage of Wound Epithelialization at Different Time Points as Assessed by the Investigator
timeFrame: up to 4 weeks
measure: Likert Scale Rating of Efficacy
timeFrame: up to 4 weeks
measure: Cosmetic Outcome at 3 and 12 Months After Surgery, Respectively
timeFrame: 3 months and 12 months
measure: Likert Scale Rating of Tolerability
timeFrame: up to 4 weeks
measure: Pharmacokinetic (PK) Data (Number of Plasma Samples With Measurable Betulin Concentration)
timeFrame: up to 4 weeks
measure: Pharmacokinetic (PK) Data (Plasma Betulin Concentration)
timeFrame: up to 4 weeks
measure: Frequency of Adverse Events
timeFrame: Day 0 (start of treatment) until end of treatment (Day 28 or earlier if full wound closure was achieved earlier).
measure: Severity of Adverse Events
timeFrame: Day 0 (start of treatment) until end of treatment (Day 28 or earlier if full wound closure was achieved earlier).
measure: Adverse Events by Relationship to Study Medication
timeFrame: Day 0 (start of treatment) until end of treatment (Day 28 or earlier if full wound closure was achieved earlier).
Other outcomes:
Locations:
city: Graz
country: Austria
facility: Medical University of Graz
city: Salzburg
country: Austria
facility: Landesklinik für Dermatologie
city: Vienna
country: Austria
facility: Medical University Vienna
city: Pleven
country: Bulgaria
facility: University Multiprofile Hospital for Active Treatment-"Dr. Georgi Stranski" EAD
city: Plovdiv
country: Bulgaria
facility: University Multiprofile Hospital for Active Treatment "Saint George"
city: Ruse
country: Bulgaria
facility: Multiprofile Hospital for Active Treatment- Ruse
city: Sofia
country: Bulgaria
facility: University Multiprofile Hospital for Active Treatment and Emergency Medicine "N.I.Pirogov"
city: Varna
country: Bulgaria
facility: University Multiprofile Hospital for Active Treatment-Varna at MMA-Sofia
city: Brno
country: Czechia
facility: Universtity Hospital Brno
city: Olomouc
country: Czechia
facility: University Hospital Olomouc
city: Lahti
country: Finland
facility: Päijät-Hämeen keskussairaala
city: Pori
country: Finland
facility: Satakunnan keskussairaala
city: Berlin
country: Germany
facility: Trauma Hospital
city: Düsseldorf
country: Germany
facility: University Hospital
city: Essen
country: Germany
facility: Essen University Hospital
city: Frankfurt
country: Germany
facility: University Hospital
city: Freiburg
country: Germany
facility: University Medical Center
city: Greifswald
country: Germany
facility: University Medicine Greifswald
city: Krefeld
country: Germany
facility: HELIOS Clinic
city: Mainz
country: Germany
facility: University Medical Center
city: München
country: Germany
facility: Klinikum rechts der Isar
city: Offenbach
country: Germany
facility: Klinikum Offenbach am Main
city: Gdansk
country: Poland
facility: Univesity Hospital Gdansk
city: Lublin
country: Poland
facility: Samodzelny Publiczny Szpital Kliniczny Nr. 1
Study officials:
affiliation: Universitätsmedizin Greifswald MKG-Chirurgie/Plastische Operationen
name: Hans Robert Metelmann, Prof
role: PRINCIPAL_INVESTIGATOR
References:
citation: Barret JP, Podmelle F, Lipovy B, Rennekampff HO, Schumann H, Schwieger-Briel A, Zahn TR, Metelmann HR; BSH-12 and BSG-12 study groups. Accelerated re-epithelialization of partial-thickness skin wounds by a topical betulin gel: Results of a randomized phase III clinical trials program. Burns. 2017 Sep;43(6):1284-1294. doi: 10.1016/j.burns.2017.03.005. Epub 2017 Apr 8.