Trial Outcomes & Findings for Oleogel-S10 in Wound Healing of Split-Thickness Skin Graft Donor Sites (BSG-12) (NCT NCT01807650)
NCT ID: NCT01807650
Last Updated: 2018-07-19
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
112 participants
Primary outcome timeframe
2 to 4 weeks
Results posted on
2018-07-19
Participant Flow
Participants were enrolled from 04 Apr 2013 to 04 Sep 2013 in 14 clinical centers in 4 countries: Spain (6 centers), Greece (3 centers), Latvia (2 centers), and France (3 centers).
113 participants were screened and wound halves of 112 participants were randomized and treated. For one participant, wound halves were neither randomized nor treated because the split-thickness skin graft surgery was cancelled. Overall, 112 wounds in 112 participants were treated.
Unit of analysis: STSG donor site wounds
Participant milestones
| Measure |
Entire Study Population
A split-thickness skin graft (STSG) donor site wound \>15cm2 in size was divided in 2 halves. One half of the STSG wound was randomized to Oleogel-S10 treatment plus non-adhesive wound dressing. The other wound half was covered with a non-adhesive wound dressing only as control (intra-individual comparison)
|
|---|---|
|
Overall Study
STARTED
|
112 112
|
|
Overall Study
COMPLETED
|
92 92
|
|
Overall Study
NOT COMPLETED
|
20 20
|
Reasons for withdrawal
| Measure |
Entire Study Population
A split-thickness skin graft (STSG) donor site wound \>15cm2 in size was divided in 2 halves. One half of the STSG wound was randomized to Oleogel-S10 treatment plus non-adhesive wound dressing. The other wound half was covered with a non-adhesive wound dressing only as control (intra-individual comparison)
|
|---|---|
|
Overall Study
Lack of Full Wound Closure at Day 28
|
13
|
|
Overall Study
Adverse Event
|
5
|
|
Overall Study
Other
|
2
|
Baseline Characteristics
Oleogel-S10 in Wound Healing of Split-Thickness Skin Graft Donor Sites (BSG-12)
Baseline characteristics by cohort
| Measure |
Entire Study Population
n=112 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
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
89 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
23 Participants
n=5 Participants
|
|
Age, Continuous
|
49 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
39 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
73 Participants
n=5 Participants
|
|
Region of Enrollment
Greece
|
14 participants
n=5 Participants
|
|
Region of Enrollment
Latvia
|
31 participants
n=5 Participants
|
|
Region of Enrollment
France
|
11 participants
n=5 Participants
|
|
Region of Enrollment
Spain
|
56 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 2 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.
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=110 Participants
All participants treated with Oleogel-S10 plus non-adhesive wound dressing and with non-adhesive wound dressing only
|
Non-adhesive Wound Dressing Only
A split-thickness skin graft (STSG) donor site wound \>15cm2 in size was divided in 2 halves. One half of the STSG wound was randomized to coverage with non-adhesive wound dressing only.
|
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
|
-0.8 days
Interval -1.5 to -0.1
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 2 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 2 of the 110 wounds, data were missing, thus the reported values are calculated from 108 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 110 participants with missing values replaced by a value of 0, for outcome measure 2 missing values were not replaced. For 2 of the 110 wounds data were missing, thus the reported values are calculated from 108 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=108 STSG Wound (Halves)
All participants treated with Oleogel-S10 plus non-adhesive wound dressing and with non-adhesive wound dressing only
|
Non-adhesive Wound Dressing Only
n=108 STSG Wound (Halves)
A split-thickness skin graft (STSG) donor site wound \>15cm2 in size was divided in 2 halves. One half of the STSG wound was randomized to coverage with non-adhesive wound dressing only.
|
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
|
15.1 Days from surgery until wound closure
Interval 14.1 to 16.1
|
16.0 Days from surgery until wound closure
Interval 14.8 to 17.1
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 2 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=110 Participants
All participants treated with Oleogel-S10 plus non-adhesive wound dressing and with non-adhesive wound dressing only
|
Non-adhesive Wound Dressing Only
n=110 Participants
A split-thickness skin graft (STSG) donor site wound \>15cm2 in size was divided in 2 halves. One half of the STSG wound was randomized to coverage with non-adhesive wound dressing only.
|
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
|
45.5 Percentage with earlier healing
Interval 35.9 to 55.2
|
30.0 Percentage with earlier healing
Interval 21.6 to 39.5
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 2 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=2 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=110 Participants
All participants treated with Oleogel-S10 plus non-adhesive wound dressing and with non-adhesive wound dressing only
|
Non-adhesive Wound Dressing Only
n=110 Participants
A split-thickness skin graft (STSG) donor site wound \>15cm2 in size was divided in 2 halves. One half of the STSG wound was randomized to coverage with non-adhesive wound dressing only.
|
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
|
2.8 Percentage with wound closure
Interval 0.6 to 7.9
|
3.7 Percentage with wound closure
Interval 1.0 to 9.2
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With Wound Closure at Different Time Points
Day 10
|
14.8 Percentage with wound closure
Interval 8.7 to 22.9
|
8.3 Percentage with wound closure
Interval 3.9 to 15.2
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With Wound Closure at Different Time Points
Day 14
|
48.1 Percentage with wound closure
Interval 38.4 to 58.0
|
48.1 Percentage with wound closure
Interval 38.4 to 58.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With Wound Closure at Different Time Points
Day 18
|
79.6 Percentage with wound closure
Interval 70.8 to 86.8
|
71.3 Percentage with wound closure
Interval 61.8 to 79.6
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With Wound Closure at Different Time Points
Day 21
|
86.1 Percentage with wound closure
Interval 78.1 to 92.0
|
80.6 Percentage with wound closure
Interval 71.8 to 87.5
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With Wound Closure at Different Time Points
Day 28
|
96.3 Percentage with wound closure
Interval 90.8 to 99.0
|
91.7 Percentage with wound closure
Interval 84.8 to 96.1
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 2 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.
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=110 Participants
All participants treated with Oleogel-S10 plus non-adhesive wound dressing and with non-adhesive wound dressing only
|
Non-adhesive Wound Dressing Only
n=110 Participants
A split-thickness skin graft (STSG) donor site wound \>15cm2 in size was divided in 2 halves. One half of the STSG wound was randomized to coverage with non-adhesive wound dressing only.
|
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 18
|
90.9 Area Percent of initial wound size
Interval 87.2 to 94.6
|
85.0 Area Percent of initial wound size
Interval 80.3 to 89.9
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Wound Epithelialization at Different Time Points as Assessed by the Investigator
Day 7
|
27.4 Area Percent of initial wound size
Interval 21.5 to 33.3
|
21.3 Area Percent of initial wound size
Interval 16.4 to 26.3
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Wound Epithelialization at Different Time Points as Assessed by the Investigator
Day 10
|
48.6 Area Percent of initial wound size
Interval 41.6 to 55.6
|
42.5 Area Percent of initial wound size
Interval 36.1 to 48.8
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Wound Epithelialization at Different Time Points as Assessed by the Investigator
Day 14
|
80.6 Area Percent of initial wound size
Interval 75.2 to 86.0
|
74.9 Area Percent of initial wound size
Interval 68.9 to 81.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Wound Epithelialization at Different Time Points as Assessed by the Investigator
Day 21
|
94.0 Area Percent of initial wound size
Interval 91.0 to 97.1
|
88.5 Area Percent of initial wound size
Interval 84.2 to 92.8
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Wound Epithelialization at Different Time Points as Assessed by the Investigator
Day 28
|
96.4 Area Percent of initial wound size
Interval 94.0 to 98.7
|
92.8 Area Percent of initial wound size
Interval 89.3 to 96.3
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 2 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=107 Participants
All participants treated with Oleogel-S10 plus non-adhesive wound dressing and with non-adhesive wound dressing only
|
Non-adhesive Wound Dressing Only
n=103 Participants
A split-thickness skin graft (STSG) donor site wound \>15cm2 in size was divided in 2 halves. One half of the STSG wound was randomized to coverage with non-adhesive wound dressing only.
|
Investigator Assessment Day 21
n=101 Participants
Efficacy as assessed by investigator at Day 21
|
Investigator Assessment Day 28
n=101 Participants
Efficacy as assessed by investigator at Day 28
|
Investigator Assessment End of Treatment
n=105 Participants
Efficacy as assessed by investigator at End of Treatment (EoT)
|
Participant Assessment Day 7
n=110 Participants
Efficacy as assessed by participant at Day 7
|
Participant Assessment Day 14
n=100 Participants
Efficacy as assessed by participant at Day 14
|
Participant Assessment Day 21
n=99 Participants
Efficacy as assessed by participant at Day 21
|
Participant Assessment Day 28
n=98 Participants
Efficacy as assessed by participant at Day 28
|
Participant Assessment EoT
n=102 Participants
Efficacy as assessed by participant at EoT
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Likert Scale Rating of Efficacy
Oleogel-S10 more effective
|
44.9 Percentage of efficacy assessments
Interval 35.2 to 54.8
|
35.0 Percentage of efficacy assessments
Interval 25.8 to 45.0
|
36.6 Percentage of efficacy assessments
Interval 27.3 to 46.8
|
33.7 Percentage of efficacy assessments
Interval 24.6 to 43.8
|
35.2 Percentage of efficacy assessments
Interval 26.2 to 45.2
|
31.7 Percentage of efficacy assessments
Interval 22.9 to 41.6
|
36.0 Percentage of efficacy assessments
Interval 26.6 to 46.2
|
35.4 Percentage of efficacy assessments
Interval 26.0 to 45.6
|
35.7 Percentage of efficacy assessments
Interval 26.3 to 46.0
|
36.3 Percentage of efficacy assessments
Interval 27.0 to 46.4
|
|
Likert Scale Rating of Efficacy
Both treatments same efficacy
|
40.2 Percentage of efficacy assessments
Interval 30.8 to 50.1
|
40.8 Percentage of efficacy assessments
Interval 31.2 to 50.9
|
36.6 Percentage of efficacy assessments
Interval 27.3 to 46.8
|
37.6 Percentage of efficacy assessments
Interval 28.2 to 47.8
|
37.1 Percentage of efficacy assessments
Interval 27.9 to 47.1
|
53.8 Percentage of efficacy assessments
Interval 43.8 to 63.7
|
38.0 Percentage of efficacy assessments
Interval 28.5 to 48.3
|
39.4 Percentage of efficacy assessments
Interval 29.7 to 49.7
|
38.8 Percentage of efficacy assessments
Interval 29.1 to 49.2
|
39.2 Percentage of efficacy assessments
Interval 29.7 to 49.4
|
|
Likert Scale Rating of Efficacy
Oleogel-S10 much more effective
|
4.7 Percentage of efficacy assessments
Interval 1.5 to 10.6
|
13.6 Percentage of efficacy assessments
Interval 7.6 to 21.8
|
16.8 Percentage of efficacy assessments
Interval 10.1 to 25.6
|
17.8 Percentage of efficacy assessments
Interval 10.9 to 26.7
|
17.1 Percentage of efficacy assessments
Interval 10.5 to 25.7
|
7.7 Percentage of efficacy assessments
Interval 3.4 to 14.6
|
15.0 Percentage of efficacy assessments
Interval 8.6 to 23.5
|
16.2 Percentage of efficacy assessments
Interval 9.5 to 24.9
|
15.3 Percentage of efficacy assessments
Interval 8.8 to 24.0
|
14.7 Percentage of efficacy assessments
Interval 8.5 to 23.1
|
|
Likert Scale Rating of Efficacy
Standard of care (SOC) more effective
|
9.3 Percentage of efficacy assessments
Interval 4.6 to 16.5
|
10.7 Percentage of efficacy assessments
Interval 5.5 to 18.3
|
9.9 Percentage of efficacy assessments
Interval 4.9 to 17.5
|
9.9 Percentage of efficacy assessments
Interval 4.9 to 17.5
|
9.5 Percentage of efficacy assessments
Interval 4.7 to 16.8
|
6.7 Percentage of efficacy assessments
Interval 2.7 to 13.4
|
11.0 Percentage of efficacy assessments
Interval 5.6 to 18.8
|
8.1 Percentage of efficacy assessments
Interval 3.6 to 15.3
|
8.2 Percentage of efficacy assessments
Interval 3.6 to 15.5
|
7.8 Percentage of efficacy assessments
Interval 3.4 to 14.9
|
|
Likert Scale Rating of Efficacy
SOC much more effective
|
0.9 Percentage of efficacy assessments
Interval 0.0 to 5.1
|
0.0 Percentage of efficacy assessments
Interval 0.0 to 0.0
|
0.0 Percentage of efficacy assessments
Interval 0.0 to 0.0
|
1.0 Percentage of efficacy assessments
Interval 0.0 to 5.4
|
1.0 Percentage of efficacy assessments
Interval 0.0 to 5.2
|
0.0 Percentage of efficacy assessments
Interval 0.0 to 0.0
|
0.0 Percentage of efficacy assessments
Interval 0.0 to 0.0
|
1.0 Percentage of efficacy assessments
Interval 0.0 to 5.5
|
2.0 Percentage of efficacy assessments
Interval 0.2 to 7.2
|
2.0 Percentage of efficacy assessments
Interval 0.2 to 6.9
|
SECONDARY outcome
Timeframe: 3 months and 12 monthsPopulation: The intent-to-treat (ITT) analysis population included 96 participants for the 3-months follow-up and 65 participants for the 12-months follow-up. \*Note: The assessment for one patient was missing as no photo was not taken at the Month 3 follow-up visit, therefore this outcome measure is based on 95 patients
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=95 Participants
All participants treated with Oleogel-S10 plus non-adhesive wound dressing and with non-adhesive wound dressing only
|
Non-adhesive Wound Dressing Only
n=95 Participants
A split-thickness skin graft (STSG) donor site wound \>15cm2 in size was divided in 2 halves. One half of the STSG wound was randomized to coverage with non-adhesive wound dressing only.
|
Investigator Assessment Day 21
n=95 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=65 Participants
Efficacy as assessed by investigator at End of Treatment (EoT)
|
Participant Assessment Day 7
n=65 Participants
Efficacy as assessed by participant at Day 7
|
Participant Assessment Day 14
n=65 Participants
Efficacy as assessed by participant at Day 14
|
Participant Assessment Day 21
n=65 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
|
18.9 Percentage of wounds
Interval 11.6 to 28.3
|
1.1 Percentage of wounds
Interval 0.0 to 5.7
|
32.6 Percentage of wounds
Interval 23.4 to 43.0
|
25.3 Percentage of wounds
Interval 16.9 to 35.2
|
13.8 Percentage of wounds
Interval 6.5 to 24.7
|
0.0 Percentage of wounds
Interval 0.0 to 0.0
|
27.7 Percentage of wounds
Interval 17.3 to 40.2
|
15.4 Percentage of wounds
Interval 7.6 to 26.5
|
—
|
—
|
|
Cosmetic Outcome at 3 and 12 Months After Surgery, Respectively
Wound half treated with wound dressing only
|
8.4 Percentage of wounds
Interval 3.7 to 15.9
|
0.0 Percentage of wounds
Interval 0.0 to 0.0
|
13.7 Percentage of wounds
Interval 7.5 to 22.3
|
14.7 Percentage of wounds
Interval 8.3 to 23.5
|
3.1 Percentage of wounds
Interval 0.4 to 10.7
|
0.0 Percentage of wounds
Interval 0.0 to 0.0
|
9.2 Percentage of wounds
Interval 3.5 to 19.0
|
4.6 Percentage of wounds
Interval 1.0 to 12.9
|
—
|
—
|
|
Cosmetic Outcome at 3 and 12 Months After Surgery, Respectively
Both equal
|
71.6 Percentage of wounds
Interval 61.4 to 80.4
|
98.9 Percentage of wounds
Interval 94.3 to 100.0
|
50.5 Percentage of wounds
Interval 40.1 to 60.9
|
56.8 Percentage of wounds
Interval 46.3 to 67.0
|
83.1 Percentage of wounds
Interval 71.7 to 91.2
|
100.0 Percentage of wounds
Interval 94.5 to 100.0
|
60.0 Percentage of wounds
Interval 47.1 to 72.0
|
80.0 Percentage of wounds
Interval 68.2 to 88.9
|
—
|
—
|
SECONDARY outcome
Timeframe: 2 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, non-adhesive wound dressing only is better tolerated, non-adhesive wound dressing only is much better tolerated).
Outcome measures
| Measure |
Entire Study Population
n=112 Participants
All participants treated with Oleogel-S10 plus non-adhesive wound dressing and with non-adhesive wound dressing only
|
Non-adhesive Wound Dressing Only
n=112 Participants
A split-thickness skin graft (STSG) donor site wound \>15cm2 in size was divided in 2 halves. One half of the STSG wound was randomized to coverage with non-adhesive wound dressing only.
|
Investigator Assessment Day 21
n=112 Participants
Efficacy as assessed by investigator at Day 21
|
Investigator Assessment Day 28
n=112 Participants
Efficacy as assessed by investigator at Day 28
|
Investigator Assessment End of Treatment
n=112 Participants
Efficacy as assessed by investigator at End of Treatment (EoT)
|
Participant Assessment Day 7
n=112 Participants
Efficacy as assessed by participant at Day 7
|
Participant Assessment Day 14
n=112 Participants
Efficacy as assessed by participant at Day 14
|
Participant Assessment Day 21
n=112 Participants
Efficacy as assessed by participant at Day 21
|
Participant Assessment Day 28
n=112 Participants
Efficacy as assessed by participant at Day 28
|
Participant Assessment EoT
n=112 Participants
Efficacy as assessed by participant at EoT
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Likert Scale Rating of Tolerability
Oleogel-S10 better tolerated
|
30.4 Percentage of participants
|
33.9 Percentage of participants
|
28.6 Percentage of participants
|
26.8 Percentage of participants
|
28.9 Percentage of participants
|
23.2 Percentage of participants
|
29.5 Percentage of participants
|
26.8 Percentage of participants
|
25.9 Percentage of participants
|
27.7 Percentage of participants
|
|
Likert Scale Rating of Tolerability
Both treatments equally well tolerated
|
58.9 Percentage of participants
|
44.6 Percentage of participants
|
46.4 Percentage of participants
|
48.2 Percentage of participants
|
49.1 Percentage of participants
|
58.0 Percentage of participants
|
37.5 Percentage of participants
|
37.5 Percentage of participants
|
40.2 Percentage of participants
|
41.1 Percentage of participants
|
|
Likert Scale Rating of Tolerability
SOC better tolerated
|
2.7 Percentage of participants
|
5.4 Percentage of participants
|
3.6 Percentage of participants
|
3.6 Percentage of participants
|
3.6 Percentage of participants
|
3.6 Percentage of participants
|
8.9 Percentage of participants
|
7.1 Percentage of participants
|
5.4 Percentage of participants
|
5.4 Percentage of participants
|
|
Likert Scale Rating of Tolerability
SOC much better tolerated
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.9 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.9 Percentage of participants
|
0.9 Percentage of participants
|
0.9 Percentage of participants
|
|
Likert Scale Rating of Tolerability
Oleogeogel-S10 much better tolerated
|
5.4 Percentage of participants
|
8.9 Percentage of participants
|
11.6 Percentage of participants
|
12.5 Percentage of participants
|
13.4 Percentage of participants
|
8.0 Percentage of participants
|
13.4 Percentage of participants
|
16.1 Percentage of participants
|
15.2 Percentage of participants
|
16.1 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=112 Plasma Samples
All participants treated with Oleogel-S10 plus non-adhesive wound dressing and with non-adhesive wound dressing only
|
Non-adhesive Wound Dressing Only
n=290 Plasma Samples
A split-thickness skin graft (STSG) donor site wound \>15cm2 in size was divided in 2 halves. One half of the STSG wound was randomized to coverage with non-adhesive wound dressing only.
|
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)
|
110 Plasma Samples
|
271 Plasma Samples
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Pharmacokinetic (PK) Data (Number of Plasma Samples With Measurable Betulin Concentration)
Samples above LLOQ
|
2 Plasma Samples
|
13 Plasma Samples
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Pharmacokinetic (PK) Data (Number of Plasma Samples With Measurable Betulin Concentration)
Samples without valid result
|
0 Plasma Samples
|
6 Plasma Samples
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: up to 4 weeksPopulation: A total of 13 participants had a total of 15 samples with betulin concentrations above the LLOQ (1 ng/mL), 2 participants with 2 samples each above LLOQ
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=2 Samples above LLOQ
All participants treated with Oleogel-S10 plus non-adhesive wound dressing and with non-adhesive wound dressing only
|
Non-adhesive Wound Dressing Only
n=13 Samples above LLOQ
A split-thickness skin graft (STSG) donor site wound \>15cm2 in size was divided in 2 halves. One half of the STSG wound was randomized to coverage with non-adhesive wound dressing only.
|
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)
|
24.0 Betulin (ng/mL)
Interval 4.1 to 43.9
|
10.4 Betulin (ng/mL)
Interval 1.1 to 68.6
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
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=112 Participants
All participants treated with Oleogel-S10 plus non-adhesive wound dressing and with non-adhesive wound dressing only
|
Non-adhesive Wound Dressing Only
A split-thickness skin graft (STSG) donor site wound \>15cm2 in size was divided in 2 halves. One half of the STSG wound was randomized to coverage with non-adhesive wound dressing only.
|
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)
|
53.6 Participants with adverse events (%)
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Frequency of Adverse Events
Serious adverse events
|
4.5 Participants with adverse events (%)
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Frequency of Adverse Events
AEs leading to discontinuation
|
3.6 Participants with adverse events (%)
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Frequency of Adverse Events
Related AEs
|
14.3 Participants with adverse events (%)
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Frequency of Adverse Events
Application site reactions
|
24.1 Participants with adverse events (%)
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Frequency of Adverse Events
Non treatment-emergent AEs
|
7.1 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=112 Participants
All participants treated with Oleogel-S10 plus non-adhesive wound dressing and with non-adhesive wound dressing only
|
Non-adhesive Wound Dressing Only
A split-thickness skin graft (STSG) donor site wound \>15cm2 in size was divided in 2 halves. One half of the STSG wound was randomized to coverage with non-adhesive wound dressing only.
|
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)
|
40.2 Participants with adverse events (%)
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Severity of Adverse Events
Moderate (CTCAE Grade 2)
|
27.7 Participants with adverse events (%)
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Severity of Adverse Events
Severe (CTCAE Grade 3)
|
7.1 Participants with adverse events (%)
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Severity of Adverse Events
Life-Threatening (CTCAE Grade 4)
|
2.7 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=112 Participants
All participants treated with Oleogel-S10 plus non-adhesive wound dressing and with non-adhesive wound dressing only
|
Non-adhesive Wound Dressing Only
A split-thickness skin graft (STSG) donor site wound \>15cm2 in size was divided in 2 halves. One half of the STSG wound was randomized to coverage with non-adhesive wound dressing only.
|
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
'Unlikely' related
|
2.7 Participants with adverse events (%)
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Adverse Events by Relationship to Study Medication
'Possibly' related
|
5.4 Participants with adverse events (%)
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Adverse Events by Relationship to Study Medication
'Probably' related
|
8.0 Participants with adverse events (%)
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Adverse Events by Relationship to Study Medication
Unknown relationship
|
1.8 Participants with adverse events (%)
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Adverse Events by Relationship to Study Medication
No relationship
|
47.3 Participants with adverse events (%)
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
Adverse Events
Entire Study Population - Systemic Adverse Events (AE)
Serious events: 4 serious events
Other events: 30 other events
Deaths: 0 deaths
Oleogel-S10 Localized Adverse Event (AE)
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Non-adhesive Wound Dressing Localized AE
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Localized AE Both Wound Halves
Serious events: 1 serious events
Other events: 9 other events
Deaths: 0 deaths
Entire Study Population -Systemic and Localized AEs
Serious events: 5 serious events
Other events: 40 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Entire Study Population - Systemic Adverse Events (AE)
n=112 participants at risk
All participants treated with Oleogel-S10 and 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 Adverse Event (AE)
n=112 participants at risk
All participants treated with Oleogel-S10 and 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 Dressing Localized AE
n=112 participants at risk
All participants treated with Oleogel-S10 and 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 with non-adhesive wound dressing only are reported in this arm.
|
Localized AE Both Wound Halves
n=112 participants at risk
All participants treated with Oleogel-S10 and non-adhesive wound dressing and 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 participant are reported in this arm.
|
Entire Study Population -Systemic and Localized AEs
n=112 participants at risk
All participants treated with Oleogel-S10 and non-adhesive wound dressing and/or non-adhesive wound dressing only. Local and systemic AEs are reported in this arm.
|
|---|---|---|---|---|---|
|
Infections and infestations
Wound infection
|
0.00%
0/112 • Day 0 (start of treatment) until end of treatment (Day 28 or earlier if full wound closure was achieved earlier).
|
0.00%
0/112 • Day 0 (start of treatment) until end of treatment (Day 28 or earlier if full wound closure was achieved earlier).
|
0.00%
0/112 • Day 0 (start of treatment) until end of treatment (Day 28 or earlier if full wound closure was achieved earlier).
|
0.89%
1/112 • Number of events 1 • Day 0 (start of treatment) until end of treatment (Day 28 or earlier if full wound closure was achieved earlier).
|
0.89%
1/112 • Number of events 1 • Day 0 (start of treatment) until end of treatment (Day 28 or earlier if full wound closure was achieved earlier).
|
|
Infections and infestations
Sepsis
|
0.89%
1/112 • 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%
0/112 • Day 0 (start of treatment) until end of treatment (Day 28 or earlier if full wound closure was achieved earlier).
|
0.00%
0/112 • Day 0 (start of treatment) until end of treatment (Day 28 or earlier if full wound closure was achieved earlier).
|
0.00%
0/112 • Day 0 (start of treatment) until end of treatment (Day 28 or earlier if full wound closure was achieved earlier).
|
0.89%
1/112 • Number of events 1 • Day 0 (start of treatment) until end of treatment (Day 28 or earlier if full wound closure was achieved earlier).
|
|
Injury, poisoning and procedural complications
Postoperative wound complication
|
0.89%
1/112 • 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%
0/112 • Day 0 (start of treatment) until end of treatment (Day 28 or earlier if full wound closure was achieved earlier).
|
0.00%
0/112 • Day 0 (start of treatment) until end of treatment (Day 28 or earlier if full wound closure was achieved earlier).
|
0.00%
0/112 • Day 0 (start of treatment) until end of treatment (Day 28 or earlier if full wound closure was achieved earlier).
|
0.89%
1/112 • Number of events 1 • Day 0 (start of treatment) until end of treatment (Day 28 or earlier if full wound closure was achieved earlier).
|
|
Psychiatric disorders
Mania
|
0.89%
1/112 • 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%
0/112 • Day 0 (start of treatment) until end of treatment (Day 28 or earlier if full wound closure was achieved earlier).
|
0.00%
0/112 • Day 0 (start of treatment) until end of treatment (Day 28 or earlier if full wound closure was achieved earlier).
|
0.00%
0/112 • Day 0 (start of treatment) until end of treatment (Day 28 or earlier if full wound closure was achieved earlier).
|
0.89%
1/112 • Number of events 1 • Day 0 (start of treatment) until end of treatment (Day 28 or earlier if full wound closure was achieved earlier).
|
|
Infections and infestations
Bacteremia
|
0.89%
1/112 • 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%
0/112 • Day 0 (start of treatment) until end of treatment (Day 28 or earlier if full wound closure was achieved earlier).
|
0.00%
0/112 • Day 0 (start of treatment) until end of treatment (Day 28 or earlier if full wound closure was achieved earlier).
|
0.00%
0/112 • Day 0 (start of treatment) until end of treatment (Day 28 or earlier if full wound closure was achieved earlier).
|
0.89%
1/112 • Number of events 1 • Day 0 (start of treatment) until end of treatment (Day 28 or earlier if full wound closure was achieved earlier).
|
|
Respiratory, thoracic and mediastinal disorders
Bronchospasm
|
0.89%
1/112 • 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%
0/112 • Day 0 (start of treatment) until end of treatment (Day 28 or earlier if full wound closure was achieved earlier).
|
0.00%
0/112 • Day 0 (start of treatment) until end of treatment (Day 28 or earlier if full wound closure was achieved earlier).
|
0.00%
0/112 • Day 0 (start of treatment) until end of treatment (Day 28 or earlier if full wound closure was achieved earlier).
|
0.89%
1/112 • 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
| Measure |
Entire Study Population - Systemic Adverse Events (AE)
n=112 participants at risk
All participants treated with Oleogel-S10 and 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 Adverse Event (AE)
n=112 participants at risk
All participants treated with Oleogel-S10 and 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 Dressing Localized AE
n=112 participants at risk
All participants treated with Oleogel-S10 and 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 with non-adhesive wound dressing only are reported in this arm.
|
Localized AE Both Wound Halves
n=112 participants at risk
All participants treated with Oleogel-S10 and non-adhesive wound dressing and 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 participant are reported in this arm.
|
Entire Study Population -Systemic and Localized AEs
n=112 participants at risk
All participants treated with Oleogel-S10 and non-adhesive wound dressing and/or non-adhesive wound dressing only. Local and systemic AEs are reported in this arm.
|
|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anemia
|
5.4%
6/112 • Number of events 6 • Day 0 (start of treatment) until end of treatment (Day 28 or earlier if full wound closure was achieved earlier).
|
0.00%
0/112 • Day 0 (start of treatment) until end of treatment (Day 28 or earlier if full wound closure was achieved earlier).
|
0.00%
0/112 • Day 0 (start of treatment) until end of treatment (Day 28 or earlier if full wound closure was achieved earlier).
|
0.00%
0/112 • Day 0 (start of treatment) until end of treatment (Day 28 or earlier if full wound closure was achieved earlier).
|
5.4%
6/112 • Number of events 6 • Day 0 (start of treatment) until end of treatment (Day 28 or earlier if full wound closure was achieved earlier).
|
|
Gastrointestinal disorders
Constipation
|
7.1%
8/112 • Number of events 8 • Day 0 (start of treatment) until end of treatment (Day 28 or earlier if full wound closure was achieved earlier).
|
0.00%
0/112 • Day 0 (start of treatment) until end of treatment (Day 28 or earlier if full wound closure was achieved earlier).
|
0.00%
0/112 • Day 0 (start of treatment) until end of treatment (Day 28 or earlier if full wound closure was achieved earlier).
|
0.00%
0/112 • Day 0 (start of treatment) until end of treatment (Day 28 or earlier if full wound closure was achieved earlier).
|
7.1%
8/112 • Number of events 8 • Day 0 (start of treatment) until end of treatment (Day 28 or earlier if full wound closure was achieved earlier).
|
|
General disorders
Pain
|
5.4%
6/112 • Number of events 6 • Day 0 (start of treatment) until end of treatment (Day 28 or earlier if full wound closure was achieved earlier).
|
0.00%
0/112 • Day 0 (start of treatment) until end of treatment (Day 28 or earlier if full wound closure was achieved earlier).
|
0.00%
0/112 • Day 0 (start of treatment) until end of treatment (Day 28 or earlier if full wound closure was achieved earlier).
|
0.00%
0/112 • Day 0 (start of treatment) until end of treatment (Day 28 or earlier if full wound closure was achieved earlier).
|
5.4%
6/112 • Number of events 6 • Day 0 (start of treatment) until end of treatment (Day 28 or earlier if full wound closure was achieved earlier).
|
|
General disorders
Pyrexia
|
10.7%
12/112 • Number of events 13 • Day 0 (start of treatment) until end of treatment (Day 28 or earlier if full wound closure was achieved earlier).
|
0.00%
0/112 • Day 0 (start of treatment) until end of treatment (Day 28 or earlier if full wound closure was achieved earlier).
|
0.00%
0/112 • Day 0 (start of treatment) until end of treatment (Day 28 or earlier if full wound closure was achieved earlier).
|
0.00%
0/112 • Day 0 (start of treatment) until end of treatment (Day 28 or earlier if full wound closure was achieved earlier).
|
10.7%
12/112 • Number of events 13 • Day 0 (start of treatment) until end of treatment (Day 28 or earlier if full wound closure was achieved earlier).
|
|
Infections and infestations
Skin infection
|
1.8%
2/112 • Number of events 2 • Day 0 (start of treatment) until end of treatment (Day 28 or earlier if full wound closure was achieved earlier).
|
0.89%
1/112 • Number of events 1 • Day 0 (start of treatment) until end of treatment (Day 28 or earlier if full wound closure was achieved earlier).
|
1.8%
2/112 • Number of events 2 • Day 0 (start of treatment) until end of treatment (Day 28 or earlier if full wound closure was achieved earlier).
|
3.6%
4/112 • Number of events 4 • Day 0 (start of treatment) until end of treatment (Day 28 or earlier if full wound closure was achieved earlier).
|
8.0%
9/112 • Number of events 9 • Day 0 (start of treatment) until end of treatment (Day 28 or earlier if full wound closure was achieved earlier).
|
|
Skin and subcutaneous tissue disorders
Pain of skin
|
3.6%
4/112 • Number of events 4 • Day 0 (start of treatment) until end of treatment (Day 28 or earlier if full wound closure was achieved earlier).
|
0.00%
0/112 • Day 0 (start of treatment) until end of treatment (Day 28 or earlier if full wound closure was achieved earlier).
|
1.8%
2/112 • Number of events 2 • Day 0 (start of treatment) until end of treatment (Day 28 or earlier if full wound closure was achieved earlier).
|
3.6%
4/112 • Number of events 4 • Day 0 (start of treatment) until end of treatment (Day 28 or earlier if full wound closure was achieved earlier).
|
8.9%
10/112 • Number of events 10 • Day 0 (start of treatment) until end of treatment (Day 28 or earlier if full wound closure was achieved earlier).
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
4.5%
5/112 • Number of events 5 • Day 0 (start of treatment) until end of treatment (Day 28 or earlier if full wound closure was achieved earlier).
|
0.89%
1/112 • 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%
0/112 • Day 0 (start of treatment) until end of treatment (Day 28 or earlier if full wound closure was achieved earlier).
|
2.7%
3/112 • Number of events 3 • Day 0 (start of treatment) until end of treatment (Day 28 or earlier if full wound closure was achieved earlier).
|
8.0%
9/112 • Number of events 9 • Day 0 (start of treatment) until end of treatment (Day 28 or earlier if full wound closure was achieved earlier).
|
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