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Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT00389753
Other study ID # 2006/326
Secondary ID
Status Withdrawn
Phase N/A
First received
Last updated

Study information

Verified date July 2021
Source University Hospital, Ghent
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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


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.


Recruitment information / eligibility

Status Withdrawn
Enrollment 0
Est. completion date
Est. primary completion date
Accepts healthy volunteers No
Gender All
Age group 3 Years to 75 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

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


Locations

Country Name City State
Belgium University Hospital Ghent Ghent

Sponsors (1)

Lead Sponsor Collaborator
University Hospital, Ghent

Country where clinical trial is conducted

Belgium, 

Outcome

Type Measure Description Time frame Safety issue
Primary Scar assessment after 1 month
Secondary Scar assessment 3, 6 and 12 months after wound closure