Study Stopped
IRB closed study due to no enrollment over 4 yrs
Efficacy of Spray Silicone in Alteration of Burn Scar
The Efficacy of Spray Silicone in the Alteration of Physical Burn Scar Characteristics: A Double Blinded Randomized Controlled Trial
1 other identifier
interventional
N/A
1 country
2
Brief Summary
In a burn population, conduct a prospective, double-blinded, randomized, controlled clinical trial to determine the ability of spray silicone to alter the physical characteristics of burn scar compared to a placebo.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started Mar 2011
Longer than P75 for not_applicable
2 active sites
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
First Submitted
Initial submission to the registry
February 23, 2010
CompletedFirst Posted
Study publicly available on registry
February 24, 2010
CompletedStudy Start
First participant enrolled
March 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2014
CompletedFebruary 4, 2015
February 1, 2015
3.8 years
February 23, 2010
February 2, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Vascularity rating, scar height, and color of burn scar (spray silicone vs placebo vs untreated)
every 2 weeks for a 12 week period
Study Arms (2)
Silicone Spray
EXPERIMENTALApply spray silicone
Saline Spray
PLACEBO COMPARATORApply Saline Spray
Interventions
Eligibility Criteria
You may qualify if:
- Military or civilian
- Between 18-60 years of age
- Subjects have experienced a deep partial thickness burn injury with a minimal size 2x6 inches in dimension
- Burn wounds must have healed by secondary intention
- Available for initial scar evaluation and bi-weekly assessments (30 minutes) and application of silicone and saline every weekday (5 minutes)
You may not qualify if:
- \<18 or \>60 years
- Available burn scar size is less then 2x6 inches
- Burn wounds healed by sheet grafting
- Unavailable for initial scar evaluation and bi-weekly assessments (30 minutes) and application of silicone and saline every weekday (5 minutes)
- Pre-existing medical conditions that have the potential to impair healing (i.e. Diabetes, Peripheral Arterial Disease, etc).
- Pregnant women will be excluded from the study because of the potential for pregnancy hormones to exacerbate the burn scar
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
US Army Institute of Surgical Research
Fort Sam Houston, Texas, 78234, United States
USAISR
Fort Sam Houston, Texas, 78234, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- FED
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 23, 2010
First Posted
February 24, 2010
Study Start
March 1, 2011
Primary Completion
December 1, 2014
Study Completion
December 1, 2014
Last Updated
February 4, 2015
Record last verified: 2015-02