Aruba Aloe Formula F-BC-096 in the Treatment of Split Thickness Donor Site After Wound Closure
NCT ID: NCT01213420
Last Updated: 2012-06-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
60 participants
INTERVENTIONAL
2010-01-31
2011-09-30
Brief Summary
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If suited for the study (= two equal donor sites) and after informed consent, patients will be observed starting the day of skin prelevation.
A coded file will be made for each patient and these files should contain the localization of both donor sites, their depth as determined by the setting of the dermatome and the treatment. Treatment for both donor sites will always be equal.
The date of wound healing of each donor site, which may only differ by a maximum of five days, will be noted. Digital photographs of the healed donor sites will be taken and the scars will be evaluated by the local researchers using the Adapted Vancouver Scar Scale prior to the start of hydration.
From that moment on one donor site will be treated with Aruba Aloe formula F-BC-096 while one of the control products will be applied to the second site. Per group of five patients per centre a different control product will be applied to the second donor site. The tubes containing these products will be colour and numerical coded. Nor the treating personnel, nor the patients will be informed which colour tubes contain the control products and which contain the Aruba Aloe formula F-BC-096. If it is necessary to apply pressure garments for one donor site, the garments will be applied for both sites.
Follow-Ups will be performed on one, three and six months after wound closure. Objective methods will be used during these follow-ups to evaluate elasticity and colour of the scar, this by using the Dermalab, the Cutometer®, the Derma Spectrometer and the Mexameter®. The evaporation, permeability and hydration of the scar will be measured by using the Tewameter® and the Corneometer®. The Reviscometer® will measure the direction of collagen and elastin. The Adapted Vancouver Scar Scale will be used as a subjective method. Also different scales for evaluation of donor site pain, patient satisfaction, product comfort, itching etc. have to be completed by the patient.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Aloë Vera FORMULA F-BC-096
Aloë Vera FORMULA F-BC-096 for scar hydration
3 applications per day during 6 months.
Aloë Vera FORMULA F-BC-096 with modified preservative
Aloë Vera with modified preservative for scar hydration
3 applications per day during 6 months
Eucerin Calming cream
Eucerin Calming cream for scar hydration
3 applications per day during 6 months
Nivea Cream
Nivea Cream for scar hydration
3 applications per day during 6 months
Interventions
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Nivea Cream for scar hydration
3 applications per day during 6 months
Aloë Vera FORMULA F-BC-096 for scar hydration
3 applications per day during 6 months.
Eucerin Calming cream for scar hydration
3 applications per day during 6 months
Aloë Vera with modified preservative for scar hydration
3 applications per day during 6 months
Eligibility Criteria
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Inclusion Criteria
* 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 Criteria
* 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.
ALL
No
Sponsors
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Belgian Foundation for Burn Injuries, Belgium
UNKNOWN
University Hospital, Ghent
OTHER
Responsible Party
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Principal Investigators
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Stan Monstrey, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
University Hospital Ghent, Belgium
Locations
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Hospital Network Antwerp
Antwerp, , Belgium
University Hospital Ghent
Ghent, , Belgium
Military Hospital
Neder-Over-Heembeek, , Belgium
Countries
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Related Links
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website University Hospital Ghent, Belgium
Other Identifiers
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2009/567
Identifier Type: -
Identifier Source: org_study_id
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