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

Purpose

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

Condition	Intervention
Hydration of Scars	Drug: Application of Aruba Aloë formula F-BC-096 or control

MedlinePlus related topics:

Scars

ChemIDplus related topics:

Aloe vera

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Active Control, Single Group Assignment, Efficacy Study

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

Further study details as provided by University Hospital, Ghent:

Primary Outcome Measures:

Scar assessment after 1 month

Secondary Outcome Measures:

Scar assessment 3, 6 and 12 months after wound closure

Estimated Enrollment:

25

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.

Eligibility

Ages Eligible for Study:	3 Years to 75 Years
Genders Eligible for Study:	Both
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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00389753

Contacts


Contact: Henk Hoeksema, Research co-ordinator	0032/(0)9/240.54.42	henk.hoeksema@UGent.be

Locations


Belgium
	University Hospital Ghent	Not yet recruiting
	Ghent, Belgium, 9000
	Contact: Henk Hoeksema, Research co-ordinator 0032/(0)9/240.54.42 henk.hoeksema@UGent.be
	Principal Investigator: Henk Hoeksema, Research co-ordinator

Sponsors and Collaborators

University Hospital, Ghent

Investigators


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

More Information

Website of the University Hospital Ghent This link exits the ClinicalTrials.gov site

Study ID Numbers:	2006/326
First Received:	October 18, 2006
Last Updated:	December 19, 2007
ClinicalTrials.gov Identifier:	NCT00389753
Health Authority:	Belgium: Institutional Review Board

Keywords provided by University Hospital, Ghent:

Scars

Hydratation

After Treatment

Study placed in the following topic categories:

Cicatrix

ClinicalTrials.gov processed this record on September 19, 2008

Sponsored by:	University Hospital, Ghent
Information provided by:	University Hospital, Ghent
ClinicalTrials.gov Identifier:	NCT00389753