Ignite Creation Date:
2024-05-06 @ 8:14 PM
Last Modification Date:
2024-10-26 @ 3:23 PM
Study NCT ID:
NCT06309446
Status:
COMPLETED
Last Update Posted:
2024-03-13
First Post:
2024-02-28
Brief Title:
Assessment of Wound Healing Cooling Efficacy and Local Tolerability of a Wound Care Hydrogel
Sponsor:
Oystershell NV
Organization:
Oystershell NV
Study Overview
Official Title:
Assessment of Wound Healing Cooling Efficacy and Local Tolerability of a Wound Care Hydrogel With Intraindividual Comparison Using an Abrasive Wound Model in a Single-center Randomized Investigatorblind Clinical Investigation
Status:
COMPLETED
Status Verified Date:
2024-03
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:
None
Brief Summary:
Test the wound healing properties of the product as well as the cooling effect and tolerability of a wound care gel
Detailed Description:
The primary goal of the study is to assess the wound healing properties in the test fields based on the level of re-epithelialization and to assess the cooling properties in the test fields immediately after the first application of the Medical Device The secondary objective was to assess the local tolerability of the test fields after inducing the wounds The cosmetic outcome was assessed by the investigator and by the subject after 31 days using a visual analog scale VAS and by the subjects on day 12 by filling a questionnaire on product performance and times to 100 healing over 75 healing respectively were derived from the re-epithelization score
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None