Status:
COMPLETED
Aruba Aloe Formula F-BC-096 in the Treatment of Split Thickness Donor Site After Wound Closure
Lead Sponsor:
University Hospital, Ghent
Collaborating Sponsors:
Belgian Foundation for Burn Injuries, Belgium
Conditions:
Wounds
Eligibility:
All Genders
Phase:
PHASE4
Brief Summary
This study is a prospective, randomized controlled, double blinded, study in a multi centre setting. Three burn centres will include 60 patients in total. If suited for the study (= two equal donor s...
Eligibility Criteria
Inclusion
- Patients must have two similar donor sites regarding location, depth and wound treatment.
- Healing time of both donor sites may differ by 5 days maximum.
- Patient compliance with therapy in relation to the protocol is necessary. In case of paediatric patients this depends on the collaboration of the parents.
- For the two donor sites to be compared, the entire after-treatment concerning pressure garments or eventual silicone sheets must be equal for both donor sites. Pressure garments and/or silicone sheets are used only in case of burn wounds within the same location.
- Patients must be available for regular and necessary follow-up (up to 6 months post healing).
- Possibility to finish all measurements during follow-up visits.
- Written authorisation of the patient, family or parents is required.
Exclusion
- Donor sites are not similar (not identical in: depth, wound treatment, healing time).
- The patient has a known allergy to Aloe Vera and/or to preservatives in cosmetic products.
- The patient is not able to follow the complete treatment schedule.
- The patient has any condition(s) that seriously compromises the patient's ability to complete this study.
- The occurrence of a traumatic wound over the healed donor site (e.g. abrasion, skin tear, …)
- The patient wishes to terminate the study.
- No informed consent before start of the trial.
Key Trial Info
Start Date :
January 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2011
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT01213420
Start Date
January 1 2010
End Date
September 1 2011
Last Update
June 14 2012
Active Locations (3)
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1
Hospital Network Antwerp
Antwerp, Belgium
2
University Hospital Ghent
Ghent, Belgium
3
Military Hospital
Neder-Over-Heembeek, Belgium