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

This study has suspended participant recruitment.
(study never started)
Sponsor:
Information provided by:
University Hospital, Ghent
ClinicalTrials.gov Identifier:
NCT00389753
First received: October 18, 2006
Last updated: September 28, 2010
Last verified: September 2010

October 18, 2006
September 28, 2010
Not Provided
Not Provided
Scar assessment after 1 month
Wound closure
Complete list of historical versions of study NCT00389753 on ClinicalTrials.gov Archive Site
Scar assessment 3, 6 and 12 months after wound closure
Scar assessment 1 month, 3 months, 6 months and 1 year after wound closure
Not Provided
Not Provided
 
Aruba Aloë Formula F-BC-096 in the Treatment of Split Thickness Donor Sites After Wound Closure
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

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

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Hydration of Scars
Drug: Application of Aruba Aloë formula F-BC-096 or control
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Suspended
25
Not Provided
Not Provided

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
Both
3 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
Belgium
 
NCT00389753
2006/326
No
Stan Monstrey, University Hospital Ghent
University Hospital, Ghent
Not Provided
Principal Investigator: Stan Monstrey, MD, PhD University Hospital, Ghent
University Hospital, Ghent
September 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP