Post Burn Pruritus Study in Patients Undergoing Wound Healing
A Pilot Study to Determine the Pruritic Benefits of Ondansetron Versus Diphenhydramine in Burn Patients Undergoing Wound Healing
1 other identifier
interventional
36
1 country
1
Brief Summary
The purpose of this study is to see if a drug called ondansetron (Zofran) controls itching from healing burn wounds as well or better than the usual drug used, diphenhydramine (Benadryl).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jun 2005
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2005
CompletedFirst Submitted
Initial submission to the registry
August 25, 2005
CompletedFirst Posted
Study publicly available on registry
August 29, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2006
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2006
CompletedJuly 28, 2008
July 1, 2008
11 months
August 25, 2005
July 24, 2008
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Ondansetron will have a greater ability to control pruritus in burn patients who are undergoing wound healing when compared to the standard of care, diphenhydramine.
14 days
Study Arms (1)
2
ACTIVE COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- Males or females; 18 years or older.
- Seen in the United States Army Institute of Surgical Research (USAISR) Burn Clinic with healing burn wounds of any percent (%) of total body surface area (TBSA) causing pruritus
- Stable medical condition
- Negative pregnancy test and not nursing
- Able to indicate status of pruritus on a numeric scale
- Able to understand and read English
You may not qualify if:
- Unstable medical condition as determined by attending burn surgeon
- Prisoner
- History of allergic reaction to serotonin inhibitors or diphenhydramine
- Pregnant or lactating
- Unable to verbalize pruritus intensity scale
- Unable to understand or read English
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
US Army Institute of Surgical Research
Fort Sam Houston, Texas, 78234, United States
Related Publications (1)
Matheson JD, Clayton J, Muller MJ. The reduction of itch during burn wound healing. J Burn Care Rehabil. 2001 Jan-Feb;22(1):76-81; discussion 75. doi: 10.1097/00004630-200101000-00017.
PMID: 11227690BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Stuart Gross, MD
Wilford Hall Medical Center, Lackland AFB, San Antonio, TX
- STUDY DIRECTOR
Steven E Wolf, MD
US Army Institute of Surgical Research, Fort Sam Houston, TX
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- FED
Study Record Dates
First Submitted
August 25, 2005
First Posted
August 29, 2005
Study Start
June 1, 2005
Primary Completion
May 1, 2006
Study Completion
May 1, 2006
Last Updated
July 28, 2008
Record last verified: 2008-07