Oleogel-S10 in Wound Healing of Split-Thickness Skin Graft Donor Sites (BSH-12)

NCT ID: NCT01657305

Last Updated: 2018-01-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 107 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-08-31
• Study Completion Date: 2014-09-30

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.

Conditions

Wounds

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Oleogel-S10, non-adhesive wound dressing

A split-thickness skin graft (STSG) donor site wound \>15cm2 in size was divided in 2 halves. One half was randomized to Oleogel-S10 treatment and non-adhesive wound dressing (intra-individual comparison). Oleogel-S10 was administered (1 cm or 100 mg per cm2 wound area corresponding to thickness of about 1 mm or 0.04 inch) every 3 to 4 days until 95% epithelialization of the wound or end of treatment at Day 28.

Group Type: EXPERIMENTAL

Oleogel-S10, non-adhesive wound dressing

Intervention Type: DRUG

1 cm or 100 mg Oleogel-S10 per cm2 wound area (corresponds to thickness of approximately 1 mm or 0.04 inch) every 3 to 4 days until 95% epithelialization of the wound or end of treatment at Day 28.

Non-adhesive wound dressing only

A STSG donor site wound \>15cm2 in size was divided in 2 halves. One half was randomized to treatment with non-adhesive wound dressing only (intra-individual comparison). Non-adhesive wound dressings are standard of care (SOC) in the treatment of STSG donor sites. Wound dressings were changed every 3 to 4 days until 95% epithelialization of the wound or end of treatment at Day 28.

Group Type: OTHER

Non-adhesive wound dressing only

Intervention Type: DEVICE

Soft silicone faced polyurethane foam dressing such as Mepilex® only every 3 to 4 days until 95% epithelialization of the wound or end of treatment at Day 28.

Interventions

Oleogel-S10, non-adhesive wound dressing

1 cm or 100 mg Oleogel-S10 per cm2 wound area (corresponds to thickness of approximately 1 mm or 0.04 inch) every 3 to 4 days until 95% epithelialization of the wound or end of treatment at Day 28.

Intervention Type: DRUG

Non-adhesive wound dressing only

Soft silicone faced polyurethane foam dressing such as Mepilex® only every 3 to 4 days until 95% epithelialization of the wound or end of treatment at Day 28.

Intervention Type: DEVICE

Other Intervention Names

Episalvan®; Mepilex®

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Birken AG

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Hans Robert Metelmann, Prof

Role: PRINCIPAL_INVESTIGATOR

Universitätsmedizin Greifswald MKG-Chirurgie/Plastische Operationen

Locations

Medical University of Graz

Graz, , Austria

Landesklinik für Dermatologie

Salzburg, , Austria

Medical University Vienna

Vienna, , Austria

University Multiprofile Hospital for Active Treatment-"Dr. Georgi Stranski" EAD

Pleven, , Bulgaria

University Multiprofile Hospital for Active Treatment "Saint George"

Plovdiv, , Bulgaria

Multiprofile Hospital for Active Treatment- Ruse

Rousse, , Bulgaria

University Multiprofile Hospital for Active Treatment and Emergency Medicine "N.I.Pirogov"

Sofia, , Bulgaria

University Multiprofile Hospital for Active Treatment-Varna at MMA-Sofia

Varna, , Bulgaria

Universtity Hospital Brno

Brno, , Czechia

University Hospital Olomouc

Olomouc, , Czechia

Päijät-Hämeen keskussairaala

Lahti, , Finland

Satakunnan keskussairaala

Pori, , Finland

Trauma Hospital

Berlin, , Germany

University Hospital

Düsseldorf, , Germany

Essen University Hospital

Essen, , Germany

University Hospital

Frankfurt, , Germany

University Medical Center

Freiburg im Breisgau, , Germany

University Medicine Greifswald

Greifswald, , Germany

HELIOS Clinic

Krefeld, , Germany

University Medical Center

Mainz, , Germany

Klinikum rechts der Isar

München, , Germany

Klinikum Offenbach am Main

Offenbach, , Germany

Univesity Hospital Gdansk

Gdansk, , Poland

Samodzelny Publiczny Szpital Kliniczny Nr. 1

Lublin, , Poland

Countries

Austria; Bulgaria; Czechia; Finland; Germany; Poland

References

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.

Reference Type: RESULT

PMID: 28400148 (View on PubMed)

Other Identifiers

2012-000777-23

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

BSH-12

Identifier Type: -

Identifier Source: org_study_id