None listed
Conditions
Brief summary
Burn injuries result in pain, inflammation and destruction of skin cells. Skin grafting will be required when the depth of the injury destroys the deeper skin layers. Despite grafting, the burn injury continues to produce inflammatory chemicals or mediators. These mediators result in a thickened and raised scar with increased sensitivity and itching. The purpose of this research is to see if Clobetasol propionate can reduce the inflammatory mediators thereby reducing active scar tissue formation.
Interventions
use of a super potent corticosteroid ointment (Clobetasol Propionate 0.05%) on grafted burn wounds.
Clobetasol Propionate ointment applied as the treatment and a common moisturizing ointment as the control.
Dosage of treatment is half fingertip unit i.e.0.25g once daily for 8 weeks, self-administered by participants.
Each patient acts as their own control, by applying the treatment or placebo to a randomized site 1 or 2(crossover). Participants being asked to wash their hands between application
use of a super potent corticosteroid ointment (Clobetasol Propionate 0.05%) on grafted burn wounds. Clobetasol Propionate ointment applied as the treatment and a common moisturizing ointment as the control. Dosage of treatment is half fingertip unit i.e.0.25g once daily for 8 weeks, self-administered by participants. Each patient acts as their own control, by applying the treatment or placebo to a randomized site 1 or 2(crossover). Participants being asked to wash their hands between application of the two ointments to avoid mixing the effect of the two ointments. The investigator will decide anatomical location of two comparable areas of 3cmx3cm that are accessible for self application of ointment and will mark them as site 1 and site 2. The jars marked A and B, will be prepared by company and the content is unknown to the investigator and the participant. The investigator then randomly allocate which jar on which site using procedure such as coin-tossing . Then the record for each participant will be made giving code number to the participant. (e.g. 001, jar A- site 1, jar B- site 2). There is no break in-between application of two ointments during the 8 weeks trial. The two ointments will be applied at the same time for 8 weeks on their allocated sites for comparison record.
Sponsors
Burns Unit
Study design
Allocation
Randomised controlled trial
Intervention model
Crossover
Primary purpose
Treatment
Masking
Blinded (masking used)
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
1. Full thickness burn wound with grafted skin 2. Anatomical location of two areas of 3cm x 3cm that is comparable and accessible for self application of ointment
Exclusion criteria
1. Co morbidity such as Type 1 and 2 Diabetes 2. Age limit <18 and >65 3. Inability to provide consent 4. Non-English speaking 5. Mental health and reduced cognizance 6. Inability to attend clinic or review process 7. Greater than 25% total body surface area (TBSA)
Outcome results
None listed