Ignite Creation Date:
2024-05-06 @ 1:26 AM
Last Modification Date:
2024-10-26 @ 11:04 AM
Study NCT ID:
NCT01807650
Status:
COMPLETED
Last Update Posted:
2018-07-19
First Post:
2013-03-05
Brief Title:
Oleogel-S10 in Wound Healing of Split-Thickness Skin Graft Donor Sites BSG-12
Sponsor:
Birken AG
Organization:
Amryt Pharma
Study Overview
Official Title:
Open Blindly Evaluated Prospective Controlled Randomized Multicenter Phase III Clinical Trial to Compare Intra-individually the Efficacy and Tolerance of Oleogel-S10 Versus Standard of Care in Accelerating the Wound Healing of Split-Thickness Skin Graft Donor Sites
Status:
COMPLETED
Status Verified Date:
2018-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
BSG-12
Brief Summary:
The main purpose of this phase III clinical trial was to show safety and efficacy of Oleogel-S10 in accelerating the wound healing of Split-Thickness Skin Graft STSG donor sites
Detailed Description:
Oleogel-S10 has shown efficacy and was well tolerated in previous clinical trials in participants with skin lesions Especially the results in a previous study with STSG donor sites suggested that Oleogel-S10 should be efficacious and safe in the treatment of superficial wounds
The present phase III clinical trial in STSG donor sites was initiated to demonstrate wound healing progress ie the time to healing and the grade of epithelialization of the wound
In this study STSG donor sites were separated into 2 wound halves Randomly assigned 1 wound half was treated with Oleogel-S10 and non-adhesive wound dressing the other wound half with non-adhesive wound dressing only standard of care
Wound healing progress was documented by photos which were assessed by expert reviewers blinded to the treatment of the wound halves
The present phase III clinical trial in STSG donor sites was initiated to demonstrate wound healing progress ie the time to healing and the grade of epithelialization of the wound
In this study STSG donor sites were separated into 2 wound halves Randomly assigned 1 wound half was treated with Oleogel-S10 and non-adhesive wound dressing the other wound half with non-adhesive wound dressing only standard of care
Wound healing progress was documented by photos which were assessed by expert reviewers blinded to the treatment of the wound halves
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2012-003390-26 | EUDRACT_NUMBER | None | None |