Trial Outcomes & Findings for Oleogel-S10 in Wound Healing of Split-Thickness Skin Graft Donor Sites (BSH-12) (NCT NCT01657305)
NCT ID: NCT01657305
Last Updated: 2018-01-23
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
107 participants
Primary outcome timeframe
up to 4 weeks
Results posted on
2018-01-23
Participant Flow
Study participants were enrolled from 03 Aug 2012 to 01 Aug 2013 in 18 clinical centers in 6 countries: Germany (8 centers), Czech Republic (2 centers), Poland (1 center), Finland (1 center), Austria (2 centers), and Bulgaria (4 centers).
111 participants were screened and wound halves of 107 participants were randomized and treated. For four screened participants, wound halves were neither randomized nor treated with study medication for the following reasons: not randomized by mistake, violation of inclusion criteria, surgery cancelled, and withdrawal of consent.
Participant milestones
| Measure |
Entire Study Population
Intraindividual comparison: A split-thickness skin graft (STSG) donor site wound ≥15 cm² in size was divided in 2 halves. One wound half was randomized to Oleogel-S10 treatment and non-adhesive wound dressing, the other half to non-adhesive wound dressing (intra-individual comparison). Non-adhesive wound dressings such as soft silicone-faced polyurethane foam dressings (e.g., Mepilex®) represent standard of care (SOC) in the treatment of STSG donor site wounds. Oleogel-S10 was administered at a thickness of approximately 1 mm or 0.04 inches. Treatment was repeated and wound dressings were changed at least every 3 to 4 days until wound closure (at least 95% epithelialisation) was achieved or the end of treatment was reached at Day 28.
|
|---|---|
|
Overall Study
STARTED
|
107
|
|
Overall Study
COMPLETED
|
82
|
|
Overall Study
NOT COMPLETED
|
25
|
Reasons for withdrawal
| Measure |
Entire Study Population
Intraindividual comparison: A split-thickness skin graft (STSG) donor site wound ≥15 cm² in size was divided in 2 halves. One wound half was randomized to Oleogel-S10 treatment and non-adhesive wound dressing, the other half to non-adhesive wound dressing (intra-individual comparison). Non-adhesive wound dressings such as soft silicone-faced polyurethane foam dressings (e.g., Mepilex®) represent standard of care (SOC) in the treatment of STSG donor site wounds. Oleogel-S10 was administered at a thickness of approximately 1 mm or 0.04 inches. Treatment was repeated and wound dressings were changed at least every 3 to 4 days until wound closure (at least 95% epithelialisation) was achieved or the end of treatment was reached at Day 28.
|
|---|---|
|
Overall Study
Lack of Wound Closure at Day 28
|
15
|
|
Overall Study
Withdrawal by Subject
|
4
|
|
Overall Study
Adverse Event
|
1
|
|
Overall Study
Lost to Follow-up
|
1
|
|
Overall Study
Did not Adhere to Protocol/Procedures
|
4
|
Baseline Characteristics
Oleogel-S10 in Wound Healing of Split-Thickness Skin Graft Donor Sites (BSH-12)
Baseline characteristics by cohort
| Measure |
Entire Study Population
n=107 Participants
Intra-individual comparison: A split-thickness skin graft (STSG) donor site wound ≥15 cm² in size was divided in 2 halves. One half was randomized to Oleogel-S10 treatment and non-adhesive wound dressing, the other half to non-adhesive wound dressing only. Non-adhesive wound dressings, specifically soft silicone faced polyurethane foam dressings (e.g., Mepilex®), represent standard of care (SOC) in the treatment of STSG donor site wounds. Oleogel-S10 was administered at a thickness of 1 mm (0.04 inches) and wound dressings were changed at least every 3 to 4 days. Study treatment continued until both wound halves were closed (at least 95% epithelialised) or ended at Day 28.
|
|---|---|
|
Age, Categorical
<=18 years
|
2 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
65 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
40 Participants
n=5 Participants
|
|
Age, Continuous
|
56 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
39 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
68 Participants
n=5 Participants
|
|
Region of Enrollment
Czech Republic
|
40 participants
n=5 Participants
|
|
Region of Enrollment
Austria
|
4 participants
n=5 Participants
|
|
Region of Enrollment
Finland
|
3 participants
n=5 Participants
|
|
Region of Enrollment
Poland
|
2 participants
n=5 Participants
|
|
Region of Enrollment
Bulgaria
|
24 participants
n=5 Participants
|
|
Region of Enrollment
Germany
|
34 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: up to 4 weeksPopulation: The intent-to-treat (ITT) analysis population included all participants who were treated at least once with study medication, i.e. who received any dose of Oleogel-S10.
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.
Outcome measures
| Measure |
Entire Study Population
n=107 Participants
All patients treated with Oleogel-S10 plus non-adhesive wound dressing and with non-adhesive wound dressing only.
|
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.
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.
|
Investigator Assessment Day 21
Efficacy as assessed by investigator at Day 21
|
Investigator Assessment Day 28
Efficacy as assessed by investigator at Day 28
|
Investigator Assessment End of Treatment
Efficacy as assessed by investigator at End of Treatment (EoT)
|
Participant Assessment Day 7
Efficacy as assessed by participant at Day 7
|
Participant Assessment Day 14
Efficacy as assessed by participant at Day 14
|
Participant Assessment Day 21
Efficacy as assessed by participant at Day 21
|
Participant Assessment Day 28
Efficacy as assessed by participant at Day 28
|
Participant Assessment EoT
Efficacy as assessed by participant at EoT
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Intra-individual Difference in Time to Wound Closure
|
-1.4 days
Interval -1.8 to -0.9
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: up to 4 weeksPopulation: The intent-to-treat (ITT) analysis population included all participants who were treated at least once with study medication, i.e. who received any dose of Oleogel-S10 and who had signed an informed consent form. For 5 of the 107 wounds, data were missing, thus the reported values are calculated from 102 STSG donor site wound halves by intervention
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 only. While outcome measure 1 (intra-individual difference in time to wound closure) was calculated based on mean intra-individual difference in time to wound closure in 107 participants with missing values replaced by a value of 0, for outcome measure 2 missing values were not replaced. For 5 of the 107 wounds data were missing, thus the reported values are calculated from 102 STSG donor site wound halves by intervention (Oleogel-S10 and non-adhesive wound dressing vs. non-adhesive wound dressing only).
Outcome measures
| Measure |
Entire Study Population
n=102 Number of STSG wound (halves) analyzed
All patients treated with Oleogel-S10 plus non-adhesive wound dressing and with non-adhesive wound dressing only.
|
Non-adhesive Wound Dressing Only
n=102 Number of STSG wound (halves) analyzed
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.
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.
|
Investigator Assessment Day 21
Efficacy as assessed by investigator at Day 21
|
Investigator Assessment Day 28
Efficacy as assessed by investigator at Day 28
|
Investigator Assessment End of Treatment
Efficacy as assessed by investigator at End of Treatment (EoT)
|
Participant Assessment Day 7
Efficacy as assessed by participant at Day 7
|
Participant Assessment Day 14
Efficacy as assessed by participant at Day 14
|
Participant Assessment Day 21
Efficacy as assessed by participant at Day 21
|
Participant Assessment Day 28
Efficacy as assessed by participant at Day 28
|
Participant Assessment EoT
Efficacy as assessed by participant at EoT
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Time From Surgery Until Wound Closure is Achieved
|
15.5 Days from surgery until wound closure
Interval 14.2 to 16.8
|
17.1 Days from surgery until wound closure
Interval 15.8 to 18.5
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: up to 4 weeksPopulation: The intent-to-treat (ITT) analysis population included all participants who were treated at least once with study medication, i.e. who received any dose of Oleogel-S10 and who had signed an informed consent form.
Percentage of participants with earlier healing of wound area treated with Oleogel-S10 and non-adhesive wound dressing compared to non-adhesive wound dressing only
Outcome measures
| Measure |
Entire Study Population
n=107 Participants
All patients treated with Oleogel-S10 plus non-adhesive wound dressing and with non-adhesive wound dressing only.
|
Non-adhesive Wound Dressing Only
n=107 Participants
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.
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.
|
Investigator Assessment Day 21
Efficacy as assessed by investigator at Day 21
|
Investigator Assessment Day 28
Efficacy as assessed by investigator at Day 28
|
Investigator Assessment End of Treatment
Efficacy as assessed by investigator at End of Treatment (EoT)
|
Participant Assessment Day 7
Efficacy as assessed by participant at Day 7
|
Participant Assessment Day 14
Efficacy as assessed by participant at Day 14
|
Participant Assessment Day 21
Efficacy as assessed by participant at Day 21
|
Participant Assessment Day 28
Efficacy as assessed by participant at Day 28
|
Participant Assessment EoT
Efficacy as assessed by participant at EoT
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants With Earlier Healing
|
61.7 Percentage with earlier healing
Interval 51.8 to 70.9
|
7.5 Percentage with earlier healing
Interval 3.3 to 14.2
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: up to 4 weeksPopulation: The intent-to-treat (ITT) analysis population included all participants who were treated at least once with study medication, i.e. who received any dose of Oleogel-S10 and who had signed an informed consent form. Data were missing for n=5 participants at all time points.
For separate time points (Day 7, Day 10, Day 14, Day 18, Day 21, and Day 28), the frequencies of wound areas which have reached wound closure were calculated.
Outcome measures
| Measure |
Entire Study Population
n=102 Participants
All patients treated with Oleogel-S10 plus non-adhesive wound dressing and with non-adhesive wound dressing only.
|
Non-adhesive Wound Dressing Only
n=102 Participants
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.
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.
|
Investigator Assessment Day 21
Efficacy as assessed by investigator at Day 21
|
Investigator Assessment Day 28
Efficacy as assessed by investigator at Day 28
|
Investigator Assessment End of Treatment
Efficacy as assessed by investigator at End of Treatment (EoT)
|
Participant Assessment Day 7
Efficacy as assessed by participant at Day 7
|
Participant Assessment Day 14
Efficacy as assessed by participant at Day 14
|
Participant Assessment Day 21
Efficacy as assessed by participant at Day 21
|
Participant Assessment Day 28
Efficacy as assessed by participant at Day 28
|
Participant Assessment EoT
Efficacy as assessed by participant at EoT
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants With Wound Closure at Different Time Points
Day 7
|
2.0 Percentage with wound closure
Interval 0.2 to 6.9
|
1.0 Percentage with wound closure
Interval 0.0 to 5.3
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With Wound Closure at Different Time Points
Day 10
|
25.5 Percentage with wound closure
Interval 17.4 to 35.1
|
15.7 Percentage with wound closure
Interval 9.2 to 24.2
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With Wound Closure at Different Time Points
Day 14
|
49.0 Percentage with wound closure
Interval 39.0 to 59.1
|
37.3 Percentage with wound closure
Interval 27.9 to 47.4
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With Wound Closure at Different Time Points
Day 18
|
70.6 Percentage with wound closure
Interval 60.7 to 79.2
|
61.8 Percentage with wound closure
Interval 51.6 to 71.2
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With Wound Closure at Different Time Points
Day 21
|
77.5 Percentage with wound closure
Interval 68.1 to 85.1
|
71.6 Percentage with wound closure
Interval 61.8 to 80.1
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With Wound Closure at Different Time Points
Day 28
|
94.1 Percentage with wound closure
Interval 87.6 to 97.8
|
90.2 Percentage with wound closure
Interval 82.7 to 95.2
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: up to 4 weeksPopulation: The intent-to-treat (ITT) analysis population included all participants who were treated at least once with study medication, i.e. who received any dose of Oleogel-S10 and who had signed an informed consent form. Data were missing for n=1 participant at all time points.
A study team member assessed the progress of wound healing by treatment regimen and noted the degree of epithelialization (expressed in percent of the original wound size) at wound dressing changes on Day 7, Day 10, Day 14, Day 18, Day 21, and Day 28.
Outcome measures
| Measure |
Entire Study Population
n=107 Participants
All patients treated with Oleogel-S10 plus non-adhesive wound dressing and with non-adhesive wound dressing only.
|
Non-adhesive Wound Dressing Only
n=107 Participants
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.
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.
|
Investigator Assessment Day 21
Efficacy as assessed by investigator at Day 21
|
Investigator Assessment Day 28
Efficacy as assessed by investigator at Day 28
|
Investigator Assessment End of Treatment
Efficacy as assessed by investigator at End of Treatment (EoT)
|
Participant Assessment Day 7
Efficacy as assessed by participant at Day 7
|
Participant Assessment Day 14
Efficacy as assessed by participant at Day 14
|
Participant Assessment Day 21
Efficacy as assessed by participant at Day 21
|
Participant Assessment Day 28
Efficacy as assessed by participant at Day 28
|
Participant Assessment EoT
Efficacy as assessed by participant at EoT
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Percentage of Wound Epithelialization at Different Time Points as Assessed by the Investigator
Day 14
|
82.2 Area Percent of initial wound size
Interval 76.9 to 87.5
|
74.3 Area Percent of initial wound size
Interval 68.5 to 80.1
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Wound Epithelialization at Different Time Points as Assessed by the Investigator
Day 18
|
89.7 Area Percent of initial wound size
Interval 85.4 to 93.9
|
82.3 Area Percent of initial wound size
Interval 77.3 to 87.3
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Wound Epithelialization at Different Time Points as Assessed by the Investigator
Day 21
|
92.2 Area Percent of initial wound size
Interval 88.6 to 95.9
|
85.8 Area Percent of initial wound size
Interval 81.3 to 90.4
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Wound Epithelialization at Different Time Points as Assessed by the Investigator
Day 28
|
93.9 Area Percent of initial wound size
Interval 90.6 to 97.2
|
90.0 Area Percent of initial wound size
Interval 85.9 to 94.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Wound Epithelialization at Different Time Points as Assessed by the Investigator
Day 7
|
36.7 Area Percent of initial wound size
Interval 30.4 to 43.0
|
28.1 Area Percent of initial wound size
Interval 22.3 to 33.9
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Wound Epithelialization at Different Time Points as Assessed by the Investigator
Day 10
|
60.0 Area Percent of initial wound size
Interval 52.9 to 67.1
|
49.9 Area Percent of initial wound size
Interval 43.0 to 56.7
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: up to 4 weeksPopulation: The intent-to-treat (ITT) analysis population included all participants who were treated at least once with study medication, i.e. who received any dose of Oleogel-S10 and who had signed an informed consent form.
Participants and investigators were asked to grade the efficacy of Oleogel-S10 and non-adhesive wound dressing versus non-adhesive wound dressing only on a 5-point Likert scale (treatment with Oleogel-S10 is much more effective, treatment with Oleogel-S10 is more effective, both treatments have the same efficacy, non-adhesive wound dressing only is more effective, non-adhesive wound dressing only is much more effective).
Outcome measures
| Measure |
Entire Study Population
n=100 Participants
All patients treated with Oleogel-S10 plus non-adhesive wound dressing and with non-adhesive wound dressing only.
|
Non-adhesive Wound Dressing Only
n=101 Participants
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.
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.
|
Investigator Assessment Day 21
n=97 Participants
Efficacy as assessed by investigator at Day 21
|
Investigator Assessment Day 28
n=95 Participants
Efficacy as assessed by investigator at Day 28
|
Investigator Assessment End of Treatment
n=104 Participants
Efficacy as assessed by investigator at End of Treatment (EoT)
|
Participant Assessment Day 7
n=100 Participants
Efficacy as assessed by participant at Day 7
|
Participant Assessment Day 14
n=101 Participants
Efficacy as assessed by participant at Day 14
|
Participant Assessment Day 21
n=97 Participants
Efficacy as assessed by participant at Day 21
|
Participant Assessment Day 28
n=95 Participants
Efficacy as assessed by participant at Day 28
|
Participant Assessment EoT
n=104 Participants
Efficacy as assessed by participant at EoT
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Likert Scale Rating of Efficacy
Oleogel-S10 much more effective
|
15.0 Percentage of efficacy asssessments
Interval 8.6 to 23.5
|
20.8 Percentage of efficacy asssessments
Interval 13.4 to 30.0
|
19.6 Percentage of efficacy asssessments
Interval 12.2 to 28.9
|
15.8 Percentage of efficacy asssessments
Interval 9.1 to 24.7
|
16.3 Percentage of efficacy asssessments
Interval 9.8 to 24.9
|
18.0 Percentage of efficacy asssessments
Interval 11.0 to 26.9
|
15.8 Percentage of efficacy asssessments
Interval 9.3 to 24.4
|
21.6 Percentage of efficacy asssessments
Interval 13.9 to 31.2
|
20.0 Percentage of efficacy asssessments
Interval 12.5 to 29.5
|
21.2 Percentage of efficacy asssessments
Interval 13.8 to 30.3
|
|
Likert Scale Rating of Efficacy
Oleogel-S10 more effective
|
46.0 Percentage of efficacy asssessments
Interval 36.0 to 56.3
|
49.5 Percentage of efficacy asssessments
Interval 39.4 to 59.6
|
51.5 Percentage of efficacy asssessments
Interval 41.2 to 61.8
|
52.6 Percentage of efficacy asssessments
Interval 42.1 to 63.0
|
51.9 Percentage of efficacy asssessments
Interval 41.9 to 61.8
|
44.0 Percentage of efficacy asssessments
Interval 34.1 to 54.3
|
46.5 Percentage of efficacy asssessments
Interval 36.5 to 56.7
|
42.3 Percentage of efficacy asssessments
Interval 32.3 to 52.7
|
42.1 Percentage of efficacy asssessments
Interval 32.0 to 52.7
|
41.3 Percentage of efficacy asssessments
Interval 31.8 to 51.4
|
|
Likert Scale Rating of Efficacy
Both treatments same efficacy
|
31.0 Percentage of efficacy asssessments
Interval 22.1 to 41.0
|
24.8 Percentage of efficacy asssessments
Interval 16.7 to 34.3
|
25.8 Percentage of efficacy asssessments
Interval 17.4 to 35.7
|
29.5 Percentage of efficacy asssessments
Interval 20.6 to 39.7
|
28.8 Percentage of efficacy asssessments
Interval 20.4 to 38.6
|
33.0 Percentage of efficacy asssessments
Interval 23.9 to 43.1
|
31.7 Percentage of efficacy asssessments
Interval 22.8 to 41.7
|
32.0 Percentage of efficacy asssessments
Interval 22.9 to 42.2
|
34.7 Percentage of efficacy asssessments
Interval 25.3 to 45.2
|
34.6 Percentage of efficacy asssessments
Interval 25.6 to 44.6
|
|
Likert Scale Rating of Efficacy
Standard of care (SOC) more effective
|
8.0 Percentage of efficacy asssessments
Interval 3.5 to 15.2
|
3.0 Percentage of efficacy asssessments
Interval 0.6 to 8.4
|
1.0 Percentage of efficacy asssessments
Interval 0.0 to 5.6
|
1.1 Percentage of efficacy asssessments
Interval 0.0 to 5.7
|
1.9 Percentage of efficacy asssessments
Interval 0.2 to 6.8
|
5.0 Percentage of efficacy asssessments
Interval 1.6 to 11.3
|
4.0 Percentage of efficacy asssessments
Interval 1.1 to 9.8
|
3.1 Percentage of efficacy asssessments
Interval 0.6 to 8.8
|
3.2 Percentage of efficacy asssessments
Interval 0.7 to 9.0
|
2.9 Percentage of efficacy asssessments
Interval 0.6 to 8.2
|
|
Likert Scale Rating of Efficacy
SOC much more effective
|
0.0 Percentage of efficacy asssessments
Interval 0.0 to 0.0
|
2.0 Percentage of efficacy asssessments
Interval 0.2 to 7.0
|
2.1 Percentage of efficacy asssessments
Interval 0.3 to 7.3
|
1.1 Percentage of efficacy asssessments
Interval 0.0 to 5.7
|
1.0 Percentage of efficacy asssessments
Interval 0.0 to 5.2
|
0.0 Percentage of efficacy asssessments
Interval 0.0 to 0.0
|
2.0 Percentage of efficacy asssessments
Interval 0.2 to 7.0
|
1.0 Percentage of efficacy asssessments
Interval 0.0 to 5.6
|
0.0 Percentage of efficacy asssessments
Interval 0.0 to 0.0
|
0.0 Percentage of efficacy asssessments
Interval 0.0 to 0.0
|
SECONDARY outcome
Timeframe: 3 months and 12 monthsPopulation: The intent-to-treat (ITT) analysis population included 87 participants for the 3-months follow-up and 83 participants for the 12-months follow-up.
Blinded photographic evaluation which wound half resembles more closely the surrounding skin with regard to texture, redness, growth of hair, and pigmentation.
Outcome measures
| Measure |
Entire Study Population
n=87 Participants
All patients treated with Oleogel-S10 plus non-adhesive wound dressing and with non-adhesive wound dressing only.
|
Non-adhesive Wound Dressing Only
n=87 Participants
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.
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.
|
Investigator Assessment Day 21
n=87 Participants
Efficacy as assessed by investigator at Day 21
|
Investigator Assessment Day 28
n=87 Participants
Efficacy as assessed by investigator at Day 28
|
Investigator Assessment End of Treatment
n=83 Participants
Efficacy as assessed by investigator at End of Treatment (EoT)
|
Participant Assessment Day 7
n=83 Participants
Efficacy as assessed by participant at Day 7
|
Participant Assessment Day 14
n=83 Participants
Efficacy as assessed by participant at Day 14
|
Participant Assessment Day 21
n=83 Participants
Efficacy as assessed by participant at Day 21
|
Participant Assessment Day 28
Efficacy as assessed by participant at Day 28
|
Participant Assessment EoT
Efficacy as assessed by participant at EoT
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Cosmetic Outcome at 3 and 12 Months After Surgery, Respectively
Wound half treated with Oleogel-S10
|
36.8 Percentage of wounds
Interval 26.7 to 47.8
|
1.1 Percentage of wounds
Interval 0.0 to 6.2
|
41.4 Percentage of wounds
Interval 30.9 to 52.4
|
31.0 Percentage of wounds
Interval 21.5 to 41.9
|
13.3 Percentage of wounds
Interval 6.8 to 22.5
|
2.4 Percentage of wounds
Interval 0.3 to 8.4
|
20.5 Percentage of wounds
Interval 12.4 to 30.8
|
10.8 Percentage of wounds
Interval 5.1 to 19.6
|
—
|
—
|
|
Cosmetic Outcome at 3 and 12 Months After Surgery, Respectively
Wound half treated with wound dressing only
|
5.7 Percentage of wounds
Interval 1.9 to 12.9
|
0.0 Percentage of wounds
Interval 0.0 to 0.0
|
6.9 Percentage of wounds
Interval 2.6 to 14.4
|
5.7 Percentage of wounds
Interval 1.9 to 12.9
|
2.4 Percentage of wounds
Interval 0.3 to 8.4
|
1.2 Percentage of wounds
Interval 0.0 to 6.5
|
8.4 Percentage of wounds
Interval 3.5 to 16.6
|
3.6 Percentage of wounds
Interval 0.8 to 10.2
|
—
|
—
|
|
Cosmetic Outcome at 3 and 12 Months After Surgery, Respectively
Both equal
|
51.7 Percentage of wounds
Interval 40.8 to 62.6
|
97.7 Percentage of wounds
Interval 91.9 to 99.7
|
47.1 Percentage of wounds
Interval 36.3 to 58.1
|
58.6 Percentage of wounds
Interval 47.6 to 69.1
|
84.3 Percentage of wounds
Interval 74.7 to 91.4
|
96.4 Percentage of wounds
Interval 89.8 to 99.2
|
68.7 Percentage of wounds
Interval 57.6 to 78.4
|
85.5 Percentage of wounds
Interval 76.1 to 92.3
|
—
|
—
|
SECONDARY outcome
Timeframe: up to 4 weeksPopulation: The safety analysis population (SAF) included all participants who received treatment at least once, i.e. who received any dose of Oleogel-S10 or standard of care (SOC). If the application of any treatment was uncertain, the participant was included in the SAF.
Participants and investigators were asked to evaluate the tolerability of Oleogel-S10 and non-adhesive wound dressing versus non-adhesive wound dressing only (standard of care) on a 5-point Likert scale (treatment with Oleogel-S10 is much better tolerated, treatment with Oleogel-S10 is better tolerated, both treatments are equally well tolerated, standard of care is better tolerated, standard of care is much better tolerated).
Outcome measures
| Measure |
Entire Study Population
n=107 Participants
All patients treated with Oleogel-S10 plus non-adhesive wound dressing and with non-adhesive wound dressing only.
|
Non-adhesive Wound Dressing Only
n=107 Participants
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.
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.
|
Investigator Assessment Day 21
n=107 Participants
Efficacy as assessed by investigator at Day 21
|
Investigator Assessment Day 28
n=107 Participants
Efficacy as assessed by investigator at Day 28
|
Investigator Assessment End of Treatment
n=107 Participants
Efficacy as assessed by investigator at End of Treatment (EoT)
|
Participant Assessment Day 7
n=107 Participants
Efficacy as assessed by participant at Day 7
|
Participant Assessment Day 14
n=107 Participants
Efficacy as assessed by participant at Day 14
|
Participant Assessment Day 21
n=107 Participants
Efficacy as assessed by participant at Day 21
|
Participant Assessment Day 28
n=107 Participants
Efficacy as assessed by participant at Day 28
|
Participant Assessment EoT
n=107 Participants
Efficacy as assessed by participant at EoT
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Likert Scale Rating of Tolerability
SOC much better tolerated
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
|
Likert Scale Rating of Tolerability
SOC better tolerated
|
4.0 Percentage of participants
|
0.0 Percentage of participants
|
2.1 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
3.0 Percentage of participants
|
4.0 Percentage of participants
|
2.1 Percentage of participants
|
1.1 Percentage of participants
|
1.0 Percentage of participants
|
|
Likert Scale Rating of Tolerability
Oleogeogel-S10 much better tolerated
|
6.0 Percentage of participants
|
9.9 Percentage of participants
|
14.4 Percentage of participants
|
11.6 Percentage of participants
|
11.5 Percentage of participants
|
10.0 Percentage of participants
|
7.9 Percentage of participants
|
16.5 Percentage of participants
|
12.6 Percentage of participants
|
13.5 Percentage of participants
|
|
Likert Scale Rating of Tolerability
Oleogel-S10 better tolerated
|
38.0 Percentage of participants
|
40.6 Percentage of participants
|
32.0 Percentage of participants
|
32.6 Percentage of participants
|
33.7 Percentage of participants
|
34.0 Percentage of participants
|
37.6 Percentage of participants
|
29.9 Percentage of participants
|
31.6 Percentage of participants
|
30.8 Percentage of participants
|
|
Likert Scale Rating of Tolerability
Both treatments equally well tolerated
|
52.0 Percentage of participants
|
49.5 Percentage of participants
|
51.5 Percentage of participants
|
55.8 Percentage of participants
|
54.8 Percentage of participants
|
53.0 Percentage of participants
|
50.5 Percentage of participants
|
51.5 Percentage of participants
|
54.7 Percentage of participants
|
54.8 Percentage of participants
|
SECONDARY outcome
Timeframe: up to 4 weeksPopulation: The safety analysis population included all participants who received treatment at least once, i.e. who received any dose of Oleogel-S10 or standard of care (SOC). If the application of any treatment was uncertain, the participant was included in the SAF.
Systemic presence/concentration of betulin in blood plasma samples. Plasma samples were collected in weekly intervals and at the end of treatment (when wound closure was achieved or at Day 28). Samples were analysed in a central laboratory with a validated LC-MS/MS method with a lower limit of quantification (LLOQ) of 1 ng/mL.
Outcome measures
| Measure |
Entire Study Population
n=107 Plasma Samples
All patients treated with Oleogel-S10 plus non-adhesive wound dressing and with non-adhesive wound dressing only.
|
Non-adhesive Wound Dressing Only
n=281 Plasma Samples
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.
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.
|
Investigator Assessment Day 21
Efficacy as assessed by investigator at Day 21
|
Investigator Assessment Day 28
Efficacy as assessed by investigator at Day 28
|
Investigator Assessment End of Treatment
Efficacy as assessed by investigator at End of Treatment (EoT)
|
Participant Assessment Day 7
Efficacy as assessed by participant at Day 7
|
Participant Assessment Day 14
Efficacy as assessed by participant at Day 14
|
Participant Assessment Day 21
Efficacy as assessed by participant at Day 21
|
Participant Assessment Day 28
Efficacy as assessed by participant at Day 28
|
Participant Assessment EoT
Efficacy as assessed by participant at EoT
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Pharmacokinetic (PK) Data (Number of Plasma Samples With Measurable Betulin Concentration)
Samples below LLOQ (<1 ng/mL)
|
105 Plasma Samples
|
272 Plasma Samples
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Pharmacokinetic (PK) Data (Number of Plasma Samples With Measurable Betulin Concentration)
Samples above LLOQ (range in ng/mL)
|
2 Plasma Samples
|
3 Plasma Samples
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Pharmacokinetic (PK) Data (Number of Plasma Samples With Measurable Betulin Concentration)
Samples with no valid result
|
0 Plasma Samples
|
6 Plasma Samples
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: up to 4 weeksPopulation: A total of 5 participants had a total of 5 samples with betulin concentrations above the LLOQ (1 ng/mL)
Systemic presence/concentration of betulin in blood plasma samples - values for the number of samples with measurable values in samples above the lower limit of quantification (LLOQ) of 1 ng/mL
Outcome measures
| Measure |
Entire Study Population
n=107 Participants
All patients treated with Oleogel-S10 plus non-adhesive wound dressing and with non-adhesive wound dressing only.
|
Non-adhesive Wound Dressing Only
n=106 Participants
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.
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.
|
Investigator Assessment Day 21
Efficacy as assessed by investigator at Day 21
|
Investigator Assessment Day 28
Efficacy as assessed by investigator at Day 28
|
Investigator Assessment End of Treatment
Efficacy as assessed by investigator at End of Treatment (EoT)
|
Participant Assessment Day 7
Efficacy as assessed by participant at Day 7
|
Participant Assessment Day 14
Efficacy as assessed by participant at Day 14
|
Participant Assessment Day 21
Efficacy as assessed by participant at Day 21
|
Participant Assessment Day 28
Efficacy as assessed by participant at Day 28
|
Participant Assessment EoT
Efficacy as assessed by participant at EoT
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Pharmacokinetic (PK) Data (Plasma Betulin Concentration)
|
2.1 Betulin (ng/mL)
Interval 1.3 to 3.0
|
2.4 Betulin (ng/mL)
Interval 1.2 to 4.6
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 0 (start of treatment) until end of treatment (Day 28 or earlier if full wound closure was achieved earlier).Population: The safety analysis population included all participants who received treatment at least once, i.e. who received any dose of Oleogel-S10 or standard of care (SOC). If the application of any treatment was uncertain, the participant was included in the SAF.
Outcome measures
| Measure |
Entire Study Population
n=107 Participants
All patients treated with Oleogel-S10 plus non-adhesive wound dressing and with non-adhesive wound dressing only.
|
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.
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.
|
Investigator Assessment Day 21
Efficacy as assessed by investigator at Day 21
|
Investigator Assessment Day 28
Efficacy as assessed by investigator at Day 28
|
Investigator Assessment End of Treatment
Efficacy as assessed by investigator at End of Treatment (EoT)
|
Participant Assessment Day 7
Efficacy as assessed by participant at Day 7
|
Participant Assessment Day 14
Efficacy as assessed by participant at Day 14
|
Participant Assessment Day 21
Efficacy as assessed by participant at Day 21
|
Participant Assessment Day 28
Efficacy as assessed by participant at Day 28
|
Participant Assessment EoT
Efficacy as assessed by participant at EoT
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Frequency of Adverse Events
Adverse events (AEs)
|
17.8 Participants with adverse events (%)
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Frequency of Adverse Events
Serious adverse events
|
1.9 Participants with adverse events (%)
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Frequency of Adverse Events
AEs leading to discontinuation
|
1.9 Participants with adverse events (%)
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Frequency of Adverse Events
Related AEs
|
2.8 Participants with adverse events (%)
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Frequency of Adverse Events
Application site reactions
|
8.4 Participants with adverse events (%)
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 0 (start of treatment) until end of treatment (Day 28 or earlier if full wound closure was achieved earlier).Population: The safety analysis population included all participants who received treatment at least once, i.e. who received any dose of Oleogel-S10 or standard of care (SOC). If the application of any treatment was uncertain, the participant was included in the SAF.
Adverse Events were graded according to the National Cancer Institute (NCI) Common Toxicity Criteria for Adverse Events (CTCAE) as being mild (NCI CTCAE Grade 1), moderate (NCI CTCAE Grade 2), severe (NCI CTCAE Grade 3), life-threatening (NCI CTCAE Grade 4) or death (NCI CTCAE Grade 5).
Outcome measures
| Measure |
Entire Study Population
n=107 Participants
All patients treated with Oleogel-S10 plus non-adhesive wound dressing and with non-adhesive wound dressing only.
|
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.
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.
|
Investigator Assessment Day 21
Efficacy as assessed by investigator at Day 21
|
Investigator Assessment Day 28
Efficacy as assessed by investigator at Day 28
|
Investigator Assessment End of Treatment
Efficacy as assessed by investigator at End of Treatment (EoT)
|
Participant Assessment Day 7
Efficacy as assessed by participant at Day 7
|
Participant Assessment Day 14
Efficacy as assessed by participant at Day 14
|
Participant Assessment Day 21
Efficacy as assessed by participant at Day 21
|
Participant Assessment Day 28
Efficacy as assessed by participant at Day 28
|
Participant Assessment EoT
Efficacy as assessed by participant at EoT
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Severity of Adverse Events
Mild (CTCAE Grade 1)
|
10.3 Participants with adverse events (%)
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Severity of Adverse Events
Moderate (CTCAE Grade 2)
|
4.7 Participants with adverse events (%)
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Severity of Adverse Events
Severe (CTCAE Grade 3)
|
4.7 Participants with adverse events (%)
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Severity of Adverse Events
Life-Threatening (CTCAE Grade 4)
|
0.0 Participants with adverse events (%)
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Severity of Adverse Events
Death (CTCAE Grade 5)
|
0.0 Participants with adverse events (%)
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 0 (start of treatment) until end of treatment (Day 28 or earlier if full wound closure was achieved earlier).Population: The safety analysis population included all participants who received treatment at least once, i.e. who received any dose of Oleogel-S10 or standard of care (SOC). If the application of any treatment was uncertain, the participant was included in the SAF.
Adverse events were assessed as being 'unlikely', 'possibly' or 'probably' related to study medication, 'not related' to study medication or the relationship to study medication was rated as 'unknown'.
Outcome measures
| Measure |
Entire Study Population
n=107 Participants
All patients treated with Oleogel-S10 plus non-adhesive wound dressing and with non-adhesive wound dressing only.
|
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.
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.
|
Investigator Assessment Day 21
Efficacy as assessed by investigator at Day 21
|
Investigator Assessment Day 28
Efficacy as assessed by investigator at Day 28
|
Investigator Assessment End of Treatment
Efficacy as assessed by investigator at End of Treatment (EoT)
|
Participant Assessment Day 7
Efficacy as assessed by participant at Day 7
|
Participant Assessment Day 14
Efficacy as assessed by participant at Day 14
|
Participant Assessment Day 21
Efficacy as assessed by participant at Day 21
|
Participant Assessment Day 28
Efficacy as assessed by participant at Day 28
|
Participant Assessment EoT
Efficacy as assessed by participant at EoT
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Adverse Events by Relationship to Study Medication
'Possibly' related
|
2.8 Participants with adverse events (%)
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Adverse Events by Relationship to Study Medication
'Probably' related
|
0.0 Participants with adverse events (%)
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Adverse Events by Relationship to Study Medication
Unknown relationship
|
0.0 Participants with adverse events (%)
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Adverse Events by Relationship to Study Medication
No relationship
|
15.9 Participants with adverse events (%)
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Adverse Events by Relationship to Study Medication
'Unlikely' related
|
0.0 Participants with adverse events (%)
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
Adverse Events
Entire Study Population - Systemic Adverse Events (AE)
Serious events: 1 serious events
Other events: 0 other events
Deaths: 0 deaths
Oleogel-S10 Localized AE
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Non-adhesive Wound Wound Dressing Localized AE
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Localized AE Both Wound Halves
Serious events: 1 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Entire Study Population - Systemic Adverse Events (AE)
n=107 participants at risk
All participants treated with Oleogel-S10 plus non-adhesive wound dressing and/or non-adhesive wound dressing only. AEs not localized to any wound application site by the investigator are reported in this arm.
|
Oleogel-S10 Localized AE
n=107 participants at risk
All participants treated with Oleogel-S10 plus non-adhesive wound dressing and/or non-adhesive wound dressing only. Application site reactions as judged by the investigator which occurred only at the Oleogel-S10 wound half are reported in this arm.
|
Non-adhesive Wound Wound Dressing Localized AE
n=107 participants at risk
All participants treated with Oleogel-S10 plus non-adhesive wound dressing and/or non-adhesive wound dressing only. Application site reactions as judged by the investigator which occurred only at the wound half treated only with non-adhesive wound dressing are reported in this arm.
|
Localized AE Both Wound Halves
n=107 participants at risk
All participants treated with Oleogel-S10 plus non-adhesive wound dressing and/or non-adhesive wound dressing only. Application site reactions as judged by the investigator which occurred at both the Oleogel-S10 wound half and the non-adhesive wound dressing only half in one patient are reported in this arm.
|
|---|---|---|---|---|
|
Skin and subcutaneous tissue disorders
Diabetic foot
|
0.93%
1/107 • Number of events 1 • Day 0 (start of treatment) until end of treatment (Day 28 or earlier if full wound closure was achieved earlier).
|
0.00%
0/107 • Day 0 (start of treatment) until end of treatment (Day 28 or earlier if full wound closure was achieved earlier).
|
0.00%
0/107 • Day 0 (start of treatment) until end of treatment (Day 28 or earlier if full wound closure was achieved earlier).
|
0.00%
0/107 • Day 0 (start of treatment) until end of treatment (Day 28 or earlier if full wound closure was achieved earlier).
|
|
Infections and infestations
Wound infection
|
0.00%
0/107 • Day 0 (start of treatment) until end of treatment (Day 28 or earlier if full wound closure was achieved earlier).
|
0.00%
0/107 • Day 0 (start of treatment) until end of treatment (Day 28 or earlier if full wound closure was achieved earlier).
|
0.00%
0/107 • Day 0 (start of treatment) until end of treatment (Day 28 or earlier if full wound closure was achieved earlier).
|
0.93%
1/107 • Number of events 1 • Day 0 (start of treatment) until end of treatment (Day 28 or earlier if full wound closure was achieved earlier).
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Publication requires approval of the sponsor without specification of an embargo time period.
- Publication restrictions are in place
Restriction type: OTHER