Ignite Creation Date:
2025-12-25 @ 1:20 AM
Ignite Modification Date:
2026-01-04 @ 8:43 AM
Study NCT ID:
NCT04084093
Status:
WITHDRAWN
Last Update Posted:
2020-04-20
First Post:
2019-09-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluating the Use of a Concentrated Surfactant Gel in Burn Patients
Sponsor:
Medline Industries
Organization:
Study Overview
Official Title:
Evaluating the Use of a Concentrated Surfactant Gel in Burn Patients
Status:
WITHDRAWN
Status Verified Date:
2019-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Study will be redesigned.
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This will be an observational study evaluating subject's perception of pain to dressing changes during removal and application of a surfactant gel. Wound healing will also be monitored. Anxiety before dressing change will be measured using a burn specific pain anxiety scale. Study intervention will include cleansing the wound per the facility's standard of care, followed by applying the investigational product on the wound. This will be followed by placing an appropriate secondary dressing.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?: