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

Ghent University Hospital (UZ)

Status

Withdrawn

Conditions

Hydration of Scars

Treatments

Drug: Application of Aruba Aloë formula F-BC-096 or control

Study type

Interventional

Funder types

Other

Identifiers

NCT00389753

2006/326

Details and patient eligibility

About

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

Full 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.

Sex

All

Ages

3 to 75 years old

Volunteers

No Healthy Volunteers

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