Ignite Creation Date:
2024-05-06 @ 8:11 AM
Last Modification Date:
2024-10-26 @ 11:57 AM
Study NCT ID:
NCT02689713
Status:
WITHDRAWN
Last Update Posted:
2018-12-17
First Post:
2016-02-04
Brief Title:
Pilot Study to Compare Topical Voriconazole to Placebo as a Pain Reducing Agent
Sponsor:
Kenneth Hargreaves
Organization:
The University of Texas Health Science Center at San Antonio
Study Overview
Official Title:
Prospective Randomized Double-blind Controlled Pilot Study to Compare Topical Voriconazole to Placebo as a Pain Reducing Agent at Skin Donor Sites
Status:
WITHDRAWN
Status Verified Date:
2018-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Inability to recruit subjects at the study site
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study seeks to test if the study drug voriconazole when applied topically to a burn wound on the skin will help to reduce pain
Detailed Description:
This single-center prospective randomized double-blind controlled pilot study conducted at San Antonio Military Medical Center will evaluate the effectiveness of topical voriconazole for pain relief at autogenous skin donor sites compared to a topical placebo application The patients will act as their own control All participants and investigators in the study will be blinded to the treatment arm utilized on each of the patients donor sites voriconazole versus placebo Patients who are scheduled for skin grafting and have met the inclusion criteria for this study will be invited to enroll in the study Only those patients who have been planned for skin graft sites that are approximately symmetrical in size will be allowed to enroll in the study The donor site wounds will be studied using a paired design consisting of voriconazole or the placebo applied topically to same-patient matched donor sites Patients will be queried via the pain assessment tool as to perceived pain at timed intervals Dialysate samples will be collected via microdialysis probes at matching timed intervals in order to measure levels of oxidized linoleic acid metabolites shown in previous studies to be present in peripheral nerves
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
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