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

Study Description

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Brief Summary:

Comparison between use of Aruba Aloë formula F-BC-096 and control.

Condition or disease	Intervention/treatment	Phase
Hydration of Scars	Drug: Application of Aruba Aloë formula F-BC-096 or control	Not Applicable

Detailed Description:

Patients with two equal donor sites will be selected for inclusion. After wound healing one donor site will be treated with Aruba Aloë Formula F-BC-096 while a control product will be applied to the second site.

If pressure garments are applied they must be equal for both donor sites. During follow-ups objective methods will be used to evaluate elasticity and colour of the scar.

Study Design

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Study Type :	Interventional (Clinical Trial)
Estimated Enrollment :	25 participants
Allocation:	Randomized
Intervention Model:	Single Group Assignment
Masking:	Double
Primary Purpose:	Treatment
Official Title:	A Prospective, Randomized, Double Blinded Controlled Clinical Trial of the Aruba Aloë Formula F-BC-096 in the Treatment of Split Thickness Donor Sites After Wound Closure

Arms and Interventions

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Outcome Measures

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Primary Outcome Measures :

1. Scar assessment after 1 month

Secondary Outcome Measures :

1. Scar assessment 3, 6 and 12 months after wound closure

Eligibility Criteria

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Ages Eligible for Study:	3 Years to 75 Years (Child, Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

• Patients must have two similar donor sites, identical in depth and wound treatment.
• Healing time of both donor sites may differ by 3 days maximum.
• Flux values determined by Laser Doppler Imaging before commencement of the therapy must be approximately similar.
• If possible, the donor sites to be compared must have the same location.
• Patient compliance with therapy in relation to the protocol is necessary. In case of pediatric patiënts this depends on 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.
• Patients must be available for regular and necessary follow-up.
• Possibility to finish all measurements during follow-up visits.
• Written authorisation of the patient, family or parents is required.

Exclusion Criteria:

• Donor sites are not similar (not identical in: depth, wound treatment, healing time and flux values)
• Children requiring sedation for LDI of donor sites
• Not following the complete treatment schedule or missing some evaluations during the follow-up period
• Patient has any condition(s) that seriously compromises the patient's ability to complete this study.
• Patient has participated in another study utilizing an investigational drug or device within the previous 30 days
• Patient has one or more medical condition(s), diabetes, including renal, hepatic, hematologic, neurologic, or immune disease that in the opinion of the investigator would make the patient an inappropriate candidate for this study
• Patients wish to terminate the study
• No informed consent before start of the trial

Contacts and Locations

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Locations

Belgium
University Hospital Ghent
Ghent, Belgium, 9000

Sponsors and Collaborators

University Hospital, Ghent

Investigators

Principal Investigator:	Stan Monstrey, MD, PhD	University Hospital, Ghent

More Information

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Additional Information:

Website of the University Hospital Ghent 

Responsible Party:	Stan Monstrey, University Hospital Ghent
ClinicalTrials.gov Identifier:	NCT00389753 History of Changes
Other Study ID Numbers:	2006/326
First Posted:	October 19, 2006
Last Update Posted:	September 29, 2010
Last Verified:	September 2010

Keywords provided by University Hospital, Ghent:

Scars; Hydratation; After Treatment