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

NCT01657305 | Completed Phase 3 Results

• 2 other identifiers: BSH-122012-000777-23
• Study Type: interventional
• Target: 107
• Locations: 6 countries
• Sites: 24

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.

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

Outcome Measures

Primary Outcomes (1)

• Intra-individual Difference in Time to Wound Closure

  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 only. Independent experts were blind to treatment and assessed efficacy based on chronological series of cropped and coded photographs by wound half that were taken before start of treatment, during wound dressing changes and at the end of treatment. Difference in time to wound closure was calculated for every individual participant as \[time taken for wound half treated with Oleogel-S10 to close\] - \[time taken for wound half treated with non-adhesive wound dressing to close\], i.e., results below 0 indicate earlier wound closure of Oleogel-S10 treatment. The overall mean difference in time to wound closure was calculated based on all mean differences in time to wound closure of individual participants. Hence, primary outcome data derived from mean difference in time to wound closure by participant.

  up to 4 weeks

Secondary Outcomes (12)

• Time From Surgery Until Wound Closure is Achieved

  up to 4 weeks

• Percentage of Participants With Earlier Healing

  up to 4 weeks

• Percentage of Participants With Wound Closure at Different Time Points

  up to 4 weeks

• Percentage of Wound Epithelialization at Different Time Points as Assessed by the Investigator

  up to 4 weeks

• Likert Scale Rating of Efficacy

  up to 4 weeks

Study Arms (2)

Oleogel-S10, non-adhesive wound dressing

EXPERIMENTAL

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.

Drug: Oleogel-S10, non-adhesive wound dressing

Non-adhesive wound dressing only

OTHER

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.

Device: Non-adhesive wound dressing only

Interventions

Oleogel-S10, non-adhesive wound dressing 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.

Also known as: Episalvan®

Oleogel-S10, non-adhesive wound dressing

Non-adhesive wound dressing only 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.

Also known as: Mepilex®

Non-adhesive wound dressing only

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Birken AG: lead

Study Sites (24)

Medical University of Graz

Graz, Austria

Location

Landesklinik für Dermatologie

Salzburg, Austria

Location

Medical University Vienna

Vienna, Austria

Location

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

Pleven, Bulgaria

Location

University Multiprofile Hospital for Active Treatment "Saint George"

Plovdiv, Bulgaria

Location

Multiprofile Hospital for Active Treatment- Ruse

Rousse, Bulgaria

Location

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

Sofia, Bulgaria

Location

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

Varna, Bulgaria

Location

Universtity Hospital Brno

Brno, Czechia

Location

University Hospital Olomouc

Olomouc, Czechia

Location

Päijät-Hämeen keskussairaala

Lahti, Finland

Location

Satakunnan keskussairaala

Pori, Finland

Location

Trauma Hospital

Berlin, Germany

Location

University Hospital

Düsseldorf, Germany

Location

Essen University Hospital

Essen, Germany

Location

University Hospital

Frankfurt, Germany

Location

University Medical Center

Freiburg im Breisgau, Germany

Location

University Medicine Greifswald

Greifswald, Germany

Location

HELIOS Clinic

Krefeld, Germany

Location

University Medical Center

Mainz, Germany

Location

Klinikum rechts der Isar

München, Germany

Location

Klinikum Offenbach am Main

Offenbach, Germany

Location

Univesity Hospital Gdansk

Gdansk, Poland

Location

Samodzelny Publiczny Szpital Kliniczny Nr. 1

Lublin, Poland

Location

Related Publications (1)

• 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.

  PMID: 28400148 RESULT

MeSH Terms

Conditions

Wounds and Injuries

Interventions

episalvan

Results Point of Contact

• Title: Head of Clinical Development
• Organization: Amryt Pharma

medinfo@amrytpharma.com

+353 1 669 4606

Study Officials

• Hans Robert Metelmann, Prof

  Universitätsmedizin Greifswald MKG-Chirurgie/Plastische Operationen

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 29, 2012
• First Posted: August 6, 2012
• Study Start: August 1, 2012
• Primary Completion: August 1, 2013
• Study Completion: September 1, 2014
• Last Updated: January 23, 2018
• Results First Posted: January 23, 2018

Record last verified: 2017-05

Data Sharing

• IPD Sharing: Will not share

Locations

CZ (2); DE (10); BU (5); AU (3); PL (2); FI (2)