NCT01213420

Aruba Aloe Formula F-BC-096 in the Treatment of Split Thickness Donor Site After Wound Closure

A Prospective, Randomized Controlled, Double Blinded, Clinical Multicentre Trial of the Aruba Aloe Formula F-BC-096 in the Treatment of Split Thickness Donor Sites After Wound Closure

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: University Hospital, Ghent · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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 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.

Conditions

• Wounds

Interventions

Type	Name	Description
OTHER	Nivea Cream for scar hydration	3 applications per day during 6 months
OTHER	Aloë Vera FORMULA F-BC-096 for scar hydration	3 applications per day during 6 months.
OTHER	Eucerin Calming cream for scar hydration	3 applications per day during 6 months
OTHER	Aloë Vera with modified preservative for scar hydration	3 applications per day during 6 months

Timeline

• Start date: 2010-01-01
• Primary completion: 2011-01-01
• Completion: 2011-09-01
• First posted: 2010-10-04
• Last updated: 2012-06-14

Locations

3 sites across 1 country: Belgium