Trial Outcomes & Findings for Oleogel-S10 Versus Standard of Care in Healing of Grade 2a Burn Wounds (NCT NCT01657292)
NCT ID: NCT01657292
Last Updated: 2015-09-28
Results Overview
Photo-based evaluation by independent experts blinded to the treatment regime.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
61 participants
Primary outcome timeframe
2 to 3 weeks
Results posted on
2015-09-28
Participant Flow
Study participants were enrolled from 31-Aug-2012 to 10-Jul-2013, in 10 clinical centres in 4 countries: Germany (4 centers), Uk (3 centers), Sweden (2 centers), and Switzerland (1 center).
66 patients were screened of which 5 violated eligibility criteria and thus 61 subjects were treated.
Participant milestones
| Measure |
Entire Study Population
All patients treated with Oleogel-S10 and Octenilin® wound gel.
|
|---|---|
|
Overall Study
STARTED
|
61
|
|
Overall Study
COMPLETED
|
51
|
|
Overall Study
NOT COMPLETED
|
10
|
Reasons for withdrawal
| Measure |
Entire Study Population
All patients treated with Oleogel-S10 and Octenilin® wound gel.
|
|---|---|
|
Overall Study
Adverse Event
|
6
|
|
Overall Study
Withdrawal by Subject
|
2
|
|
Overall Study
Violation of eligibility criteria
|
1
|
|
Overall Study
Change of therapy
|
1
|
Baseline Characteristics
Oleogel-S10 Versus Standard of Care in Healing of Grade 2a Burn Wounds
Baseline characteristics by cohort
| Measure |
Entire Study Population
n=61 Participants
All patients treated with Oleogel-S10 and Octenilin® wound gel.
|
|---|---|
|
Age, Categorical
<=18 years
|
1 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
54 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
6 Participants
n=5 Participants
|
|
Age, Continuous
|
41 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
19 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
42 Participants
n=5 Participants
|
|
Region of Enrollment
Sweden
|
3 participants
n=5 Participants
|
|
Region of Enrollment
United Kingdom
|
28 participants
n=5 Participants
|
|
Region of Enrollment
Switzerland
|
4 participants
n=5 Participants
|
|
Region of Enrollment
Germany
|
26 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 2 to 3 weeksPopulation: The analysis included all patients who were treated at least once with Oleogel-S10 or Octenilin® wound gel (as randomised) and for whom a difference in wound healing between the treatment was observed.
Photo-based evaluation by independent experts blinded to the treatment regime.
Outcome measures
| Measure |
Entire Study Population
n=35 Participants
All patients treated with Oleogel-S10 and Octenilin® wound gel.
|
|---|---|
|
Percentage of Patients With Earlier Healing of the Wound Half Treated With Oleogel-S10 Compared to the Wound Half Receiving Standard of Care
|
85.7 percentage of patients
Interval 69.7 to 95.2
|
SECONDARY outcome
Timeframe: 2 to 3 weeksOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 2 to 3 weeksOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 2 to 3 weeksOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 2 to 3 weeksOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 2 to 3 weeksBy direct comparison of the separate simultaneous treatments for the two wound halves, patients and investigators, respectively, are asked to grade the efficacy of Oleogel-S10 Versus Standard of Care on a questionnaire with a 5-point graded visual analogue scale
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 3 and 12 monthsOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 2 to 3 weeksBy direct comparison of the separate simultaneous treatments for the two wound halves, patients and investigators, respectively, are asked to provide their opinion on the tolerance of Oleogel-S10 Versus Standard of Care on a questionnaire with a 5-point graded visual analogue scale
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 2 to 3 weeksOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 2 to 3 weeksOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 2 to 3 weeksOutcome measures
Outcome data not reported
Adverse Events
Entire Study Population - Systemic AEs
Serious events: 2 serious events
Other events: 0 other events
Deaths: 0 deaths
Oleogel-S10 Localized AE
Serious events: 1 serious events
Other events: 0 other events
Deaths: 0 deaths
Octenilin Localized AE
Serious events: 1 serious events
Other events: 0 other events
Deaths: 0 deaths
Localized AE Both Wound Halves
Serious events: 4 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Entire Study Population - Systemic AEs
n=61 participants at risk
All patients treated with Oleogel-S10 and Octenilin® wound gel. Systemic AEs which are not localized to the wound application site are reported under this arm.
|
Oleogel-S10 Localized AE
n=61 participants at risk
All patients treated with Oleogel-S10 and Octenilin® wound gel. Application site reactions which occurred only at the Oleogel-S10 wound half are reported under this arm.
|
Octenilin Localized AE
n=61 participants at risk
All patients treated with Oleogel-S10 and Octenilin® wound gel. Application site reactions which occurred only at the Octenilin® wound half are reported under this arm.
|
Localized AE Both Wound Halves
n=61 participants at risk
All patients treated with Oleogel-S10 and Octenilin® wound gel. Application site reactions which occurred at both the Octenilin® wound half and Oleogel-S10 wound half in one patient are reported under this arm.
|
|---|---|---|---|---|
|
Injury, poisoning and procedural complications
Wound necrosis
|
0.00%
0/61 • Day 0 (start of treatment) till end of treatment (Day 21 or earlier if full wound closure was achieved earlier, or later, if the investigator decided to change medication and/or treatment due to unsatisfying wound closure after Day 21).
|
1.6%
1/61 • Day 0 (start of treatment) till end of treatment (Day 21 or earlier if full wound closure was achieved earlier, or later, if the investigator decided to change medication and/or treatment due to unsatisfying wound closure after Day 21).
|
0.00%
0/61 • Day 0 (start of treatment) till end of treatment (Day 21 or earlier if full wound closure was achieved earlier, or later, if the investigator decided to change medication and/or treatment due to unsatisfying wound closure after Day 21).
|
0.00%
0/61 • Day 0 (start of treatment) till end of treatment (Day 21 or earlier if full wound closure was achieved earlier, or later, if the investigator decided to change medication and/or treatment due to unsatisfying wound closure after Day 21).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tonsil cancer
|
1.6%
1/61 • Day 0 (start of treatment) till end of treatment (Day 21 or earlier if full wound closure was achieved earlier, or later, if the investigator decided to change medication and/or treatment due to unsatisfying wound closure after Day 21).
|
0.00%
0/61 • Day 0 (start of treatment) till end of treatment (Day 21 or earlier if full wound closure was achieved earlier, or later, if the investigator decided to change medication and/or treatment due to unsatisfying wound closure after Day 21).
|
0.00%
0/61 • Day 0 (start of treatment) till end of treatment (Day 21 or earlier if full wound closure was achieved earlier, or later, if the investigator decided to change medication and/or treatment due to unsatisfying wound closure after Day 21).
|
0.00%
0/61 • Day 0 (start of treatment) till end of treatment (Day 21 or earlier if full wound closure was achieved earlier, or later, if the investigator decided to change medication and/or treatment due to unsatisfying wound closure after Day 21).
|
|
General disorders
Condition aggravated
|
0.00%
0/61 • Day 0 (start of treatment) till end of treatment (Day 21 or earlier if full wound closure was achieved earlier, or later, if the investigator decided to change medication and/or treatment due to unsatisfying wound closure after Day 21).
|
0.00%
0/61 • Day 0 (start of treatment) till end of treatment (Day 21 or earlier if full wound closure was achieved earlier, or later, if the investigator decided to change medication and/or treatment due to unsatisfying wound closure after Day 21).
|
0.00%
0/61 • Day 0 (start of treatment) till end of treatment (Day 21 or earlier if full wound closure was achieved earlier, or later, if the investigator decided to change medication and/or treatment due to unsatisfying wound closure after Day 21).
|
3.3%
2/61 • Day 0 (start of treatment) till end of treatment (Day 21 or earlier if full wound closure was achieved earlier, or later, if the investigator decided to change medication and/or treatment due to unsatisfying wound closure after Day 21).
|
|
General disorders
Pyrexia
|
1.6%
1/61 • Day 0 (start of treatment) till end of treatment (Day 21 or earlier if full wound closure was achieved earlier, or later, if the investigator decided to change medication and/or treatment due to unsatisfying wound closure after Day 21).
|
0.00%
0/61 • Day 0 (start of treatment) till end of treatment (Day 21 or earlier if full wound closure was achieved earlier, or later, if the investigator decided to change medication and/or treatment due to unsatisfying wound closure after Day 21).
|
0.00%
0/61 • Day 0 (start of treatment) till end of treatment (Day 21 or earlier if full wound closure was achieved earlier, or later, if the investigator decided to change medication and/or treatment due to unsatisfying wound closure after Day 21).
|
0.00%
0/61 • Day 0 (start of treatment) till end of treatment (Day 21 or earlier if full wound closure was achieved earlier, or later, if the investigator decided to change medication and/or treatment due to unsatisfying wound closure after Day 21).
|
|
Infections and infestations
Soft tissue infection
|
0.00%
0/61 • Day 0 (start of treatment) till end of treatment (Day 21 or earlier if full wound closure was achieved earlier, or later, if the investigator decided to change medication and/or treatment due to unsatisfying wound closure after Day 21).
|
0.00%
0/61 • Day 0 (start of treatment) till end of treatment (Day 21 or earlier if full wound closure was achieved earlier, or later, if the investigator decided to change medication and/or treatment due to unsatisfying wound closure after Day 21).
|
1.6%
1/61 • Day 0 (start of treatment) till end of treatment (Day 21 or earlier if full wound closure was achieved earlier, or later, if the investigator decided to change medication and/or treatment due to unsatisfying wound closure after Day 21).
|
0.00%
0/61 • Day 0 (start of treatment) till end of treatment (Day 21 or earlier if full wound closure was achieved earlier, or later, if the investigator decided to change medication and/or treatment due to unsatisfying wound closure after Day 21).
|
|
Infections and infestations
Wound infection
|
0.00%
0/61 • Day 0 (start of treatment) till end of treatment (Day 21 or earlier if full wound closure was achieved earlier, or later, if the investigator decided to change medication and/or treatment due to unsatisfying wound closure after Day 21).
|
0.00%
0/61 • Day 0 (start of treatment) till end of treatment (Day 21 or earlier if full wound closure was achieved earlier, or later, if the investigator decided to change medication and/or treatment due to unsatisfying wound closure after Day 21).
|
0.00%
0/61 • Day 0 (start of treatment) till end of treatment (Day 21 or earlier if full wound closure was achieved earlier, or later, if the investigator decided to change medication and/or treatment due to unsatisfying wound closure after Day 21).
|
3.3%
2/61 • Day 0 (start of treatment) till end of treatment (Day 21 or earlier if full wound closure was achieved earlier, or later, if the investigator decided to change medication and/or treatment due to unsatisfying wound closure after Day 21).
|
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