Accelerating the Epithelialization of Split Thickness Skin GraftPhase 2OleoSplitNCT01294254
Trial to Compare Intra-individually the Efficacy and Tolerance of Oleogel-S10 Versus Moist Wound Healing Dressing Alone in Accelerating the Epithelialization of Split Thickness Skin Graft Donor Sites
A Phase 2 study testing Oleogel-S10 and Moist wound healing dressings alone (Mepilex) on the other half of the skin graft donor site in people with Accelerating the Epithelialization of Split Thickness Skin Graft, run by Birken AG at 2 sites in Germany.
Trial summary
In this study the wound reepithelialization of that part of the skin graft donor site, which is treated with Oleogel-S10 compared to that part of the wound, which is covered by moist wound healing dressing alone will be investigated. Read more about this study
- Who is it for?
- Ages 18 to 95 years
- Conditions the study is for
- Accelerating the Epithelialization of Split Thickness Skin Graft
- What is being tested?
- Oleogel-S10 and Moist wound healing dressings alone (Mepilex) on the other half of the skin graft donor site
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 2 sitesGermany
- Study dates
- Apr 2010to Nov 2010
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 95 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients may participate in the study if they have/are
- Patients aged 18-95 years who have provided written informed consent.
- Patients requiring skin grafting due to burns, trauma, chronic venous ulcers, or surgical removal of cutaneous malignancies with a donor site expected to be between 8 and 200 cm2 on a non-articulated area.
- Patient is prepared to comply with all study requirements, including the following:
- Application of Oleogel-S10 on the SSG at every change of wound dressing;
- Regular clinic visits during the treatment period, and follow-up period.
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- Negative pregnancy test of women of childbearing potential performed within 7 days prior to the start of treatment.
- Women of childbearing potential must agree to use an effective method of contraception (Pearl-Index < 1, e.g. hormonal contraception including the combined oral contraceptive pill, the transdermal patch, and the contraceptive vaginal ring, intrauterine devices or sterilization) during treatment and for at least 6 months thereafter.
- Men must agree to use an effective method of contraception during treatment and for at least 6 months thereafter.
Who cannot join
- Patients will be excluded from the study if they have/are
- burns involving more than 15% of their total body area;
- sepsis, haemodynamic instability requiring pressor support or positive blood microbiology cultures within 48h of surgery;
- inhalation injury requiring artificial respiratory assistance;
- requiring skin grafts following removal of suspicious skin lesions;
- received treatment with systemic steroids during the 30 days prior to surgery;
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- uncontrolled diabetes or diabetic ulcers;
- diseases or conditions that could, in the opinion of the Investigator, interfere with the assessment of safety, tolerance or efficacy;
- previously skin grafts harvested from the area to be studied;
- 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;
- undergoing investigations or changes in management for an existing medical condition;
- not likely to complete the trial for whatever reason.
Trial locations and contacts
2 sites in 1 country.
Germany2 sites
Universitäts-Hautklinik Freiburg
Freiburg im Breisgau, 79104
Universitätsklinikum der Ernst-Moritz-Arndt-Universität Greifswald
Greifswald, 17475
About this study
Official title: Open, Prospective, Controlled, Randomised, Multicenter Phase II Clinical Trial to Compare Intra-individually the Efficacy and Tolerance of Oleogel-S10 Versus Moist Wound Healing Dressing Alone in Accelerating the Epithelialization of Split Thickness Skin Graft Donor Sites
In this study the wound reepithelialization of that part of the skin graft donor site, which is treated with Oleogel-S10 compared to that part of the wound, which is covered by moist wound healing dressing alone will be investigated.
Read the detailed description
As a first step, an adequate size of the wound healing dressing (Mepilex) is taken and cut in half. Then, half of the SSG (split skin graft) wound is covered conventionally by applying one half of the Mepilex cut. Afterwards Oleogel-S10 is applied to the other half of the Mepilex cut, which is used to cover the other half of the SSG wound. Both parts of the Mepilex dressings are then covered by an additional conventional dressing.
Oleogel-S10 is always applied to the same part of the SSG wound for each patient, respectively, depending on the randomization of the patient, either towards the periphery of the body, i.e. the lower part of the leg, or towards the centre part of the body, i.e. the upper part of the leg. In order to avoid a confusion about which part has to be treated with Oleogel-S10, the healthy skin next to the SSG wound will be marked with ink for indication of the Oleogel-treated part of the wound.
Each day during the treatment period, whenever the wound dressing is changed, a clinical examination and assessment of the progress of epithelialization of the SSG wound will be conducted, including evaluation of tolerance, and photos of the wound without dressing will be taken.
A blinded assessment of the efficacy is conducted by two independent investigators using the macro-photos of every day, when wound dressings were changed, and a final examination is done. In this assessment, the third part of the SSG wound that is in between the left and right parts is neglected.
- Being tested
- Oleogel-S10, Moist wound healing dressings alone (Mepilex) on the other half of the skin graft donor site
- Keywords
- wound reepithelialization
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oleogel-S10Drug
Oleogel-S10 on one half of the skin graft donor site (each time when the wound dressing is changed during a time period of 14 days, normally once daily)
Moist wound healing dressings alone (Mepilex) on the other half of the skin graft donor siteProcedure or surgery
wound is covered conventionally by applying one half of the Mepilex cut
| Study group | Role | What they receive |
|---|---|---|
| experimantal: wound site will be treated with Oleogel-S10 | Experimental | The patients will be randomised in a ratio of 1:1 with regard to the part of the skin graft donor site that is treated with Oleogel-S10.
Arm A: application of Oleogel-S10 towards the periphery of the body, i.e. the lower part of the leg
Arm B: application of Oleogel-S10 towards the centre part of the body, i.e. the upper part of the leg
* Oleogel-S10 on one half of the skin graft donor site (each time when the wound dressing is changed during a time period of 14 days, normally once daily)
* Moist wound healing dressings alone (Mepilex) on the other half of the skin graft donor site Receives: Drug: Oleogel-S10 |
| Moist wound healing dressing alone | Active comparator | Treatment with moist wound healing dressings alone (Mepilex) on the other half of the skin graft donor site Receives: Procedure: Moist wound healing dressings alone (Mepilex) on the other half of the skin graft donor site |
What is being measured
The primary outcome is the main question the study is designed to answer.
Wound reepithelialization of that part of the skin graft donor site, which is treated with Oleogel-S10 compared to that part of the wound, which is covered by moist wound healing dressing alone during a treatment period of 14 days.
Measured: 14 days
Secondary outcomes (4)
• Size of wound epithelialization
Measured: 3 months
• Touch sensitivity: Sensitivity of the SSG wound by touching it with a spatula or cotton swabs (visual analogue scale from "no" = 0 to "severe" = "10"
Measured: 3 months
• Pruritus (visual analogue scale from "no" = 0 to "strong" = "10")
Measured: 3 months
• Reconstitution of the skin (% reepithelization) 3 months after skin explantation
Evaluation of wound closure by assessment of epithelialization (in %)
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2011 (estimated)
- Study startApr 2010
- Primary completionNov 2010
- Study completionNov 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Accelerating the Epithelialization of Split Thickness Skin GraftStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Birken AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Hans Robert Metelmann, Prof. Dr. med., Principal investigator, University Hospital of Ernst-Moritz-Arndt-University Greifswald
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01294254
- Sponsor's protocol ID
- BSH-10
- Acronym
- OleoSplit
- Status last verified
- Apr 2015
- First submitted
- 14 Apr 2010
- Last updated
- 3 Apr 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Metelmann HR, Brandner JM, Schumann H, Bross F, Fimmers R, Bottger K, Scheffler A, Podmelle F. Accelerated reepithelialization by triterpenes: proof of concept in the healing of surgical skin lesions. Skin Pharmacol Physiol. 2015;28(1):1-11. doi: 10.1159/000357501. Epub 2014 Jul 15.
PubMed 25034442
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open, Prospective, Controlled, Randomised, Multicenter Phase II Clinical Trial to Compare Intra-individually the Efficacy and Tolerance of Oleogel-S10 Versus Moist Wound Healing Dressing Alone in Accelerating the Epithelialization of Split Thickness Skin Graft Donor Sites
- ClinicalTrials.gov ID
- NCT01294254
- Acronym / sponsor ID
- OleoSplit / BSH-10
- Keywords
- wound reepithelialization
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Birken AGIndustry (pharma, biotech, devices)
- Study start
- Apr 2010
- Primary completion
- Nov 2010 (actual)
- Study completion
- Nov 2010 (actual)
- First posted
- 11 Feb 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
In this study the wound reepithelialization of that part of the skin graft donor site, which is treated with Oleogel-S10 compared to that part of the wound, which is covered by moist wound healing dressing alone will be investigated.
Detailed description
As a first step, an adequate size of the wound healing dressing (Mepilex) is taken and cut in half. Then, half of the SSG (split skin graft) wound is covered conventionally by applying one half of the Mepilex cut. Afterwards Oleogel-S10 is applied to the other half of the Mepilex cut, which is used to cover the other half of the SSG wound. Both parts of the Mepilex dressings are then covered by an additional conventional dressing.
Oleogel-S10 is always applied to the same part of the SSG wound for each patient, respectively, depending on the randomization of the patient, either towards the periphery of the body, i.e. the lower part of the leg, or towards the centre part of the body, i.e. the upper part of the leg. In order to avoid a confusion about which part has to be treated with Oleogel-S10, the healthy skin next to the SSG wound will be marked with ink for indication of the Oleogel-treated part of the wound.
Each day during the treatment period, whenever the wound dressing is changed, a clinical examination and assessment of the progress of epithelialization of the SSG wound will be conducted, including evaluation of tolerance, and photos of the wound without dressing will be taken.
A blinded assessment of the efficacy is conducted by two independent investigators using the macro-photos of every day, when wound dressings were changed, and a final examination is done. In this assessment, the third part of the SSG wound that is in between the left and right parts is neglected.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| experimantal: wound site will be treated with Oleogel-S10 | Experimental | Drug: Oleogel-S10The patients will be randomised in a ratio of 1:1 with regard to the part of the skin graft donor site that is treated with Oleogel-S10. Arm A: application of Oleogel-S10 towards the periphery of the body, i.e. the lower part of the leg Arm B: application of Oleogel-S10 towards the centre part of the body, i.e. the upper part of the leg * Oleogel-S10 on one half of the skin graft donor site (each time when the wound dressing is changed during a time period of 14 days, normally once daily) * Moist wound healing dressings alone (Mepilex) on the other half of the skin graft donor site |
| Moist wound healing dressing alone | Active comparator | Procedure: Moist wound healing dressings alone (Mepilex) on the other half of the skin graft donor siteTreatment with moist wound healing dressings alone (Mepilex) on the other half of the skin graft donor site |
Who may qualify
- Ages
- 18 to 95 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Patients may participate in the study if they have/are
- Patients aged 18-95 years who have provided written informed consent.
- Patients requiring skin grafting due to burns, trauma, chronic venous ulcers, or surgical removal of cutaneous malignancies with a donor site expected to be between 8 and 200 cm2 on a non-articulated area.
- Patient is prepared to comply with all study requirements, including the following:
- Negative pregnancy test of women of childbearing potential performed within 7 days prior to the start of treatment.
Key exclusion criteria (15 listed)
- Patients will be excluded from the study if they have/are
- burns involving more than 15% of their total body area;
- sepsis, haemodynamic instability requiring pressor support or positive blood microbiology cultures within 48h of surgery;
- inhalation injury requiring artificial respiratory assistance;
- requiring skin grafts following removal of suspicious skin lesions;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Oleogel-S10Oleogel-S10 on one half of the skin graft donor site (each time when the wound dressing is changed during a time period of 14 days, normally once daily) | Drug | experimantal: wound site will be treated with Oleogel-S10 |
| Moist wound healing dressings alone (Mepilex) on the other half of the skin graft donor sitewound is covered conventionally by applying one half of the Mepilex cut | Procedure or surgery | Moist wound healing dressing alone |
Primary outcome
Wound reepithelialization of that part of the skin graft donor site, which is treated with Oleogel-S10 compared to that part of the wound, which is covered by moist wound healing dressing alone during a treatment period of 14 days.
Time frame: 14 days
4 secondary outcomes
• Size of wound epithelialization
Time frame: 3 months
• Touch sensitivity: Sensitivity of the SSG wound by touching it with a spatula or cotton swabs (visual analogue scale from "no" = 0 to "severe" = "10"
Time frame: 3 months
• Pruritus (visual analogue scale from "no" = 0 to "strong" = "10")
Time frame: 3 months
• Reconstitution of the skin (% reepithelization) 3 months after skin explantation
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2015.
- Results publication: PubMed 25034442Metelmann HR, Brandner JM, Schumann H, Bross F, Fimmers R, Bottger K, Scheffler A, Podmelle F. Accelerated reepithelialization by triterpenes: proof of concept in the healing of surgical skin lesions. Skin Pharmacol Physiol. 2015;28(1):1-11. doi: 10.1159/000357501. Epub 2014 Jul 15.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hans Robert Metelmann, Prof. Dr. med. principal investigator
University Hospital of Ernst-Moritz-Arndt-University Greifswald
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Oleogel-S10 and Moist wound healing dressings alone (Mepilex) on the other half of the skin graft donor site in people with Accelerating the Epithelialization of Split Thickness Skin Graft, run by Birken AG at 2 sites in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Wound reepithelialization of that part of the skin graft donor site, which is treated with Oleogel-S10 compared to that part of the wound, which is covered by moist wound healing dressing alone during a treatment period of 14 days. (time frame: 14 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01294254, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Apr 2015.