Aruba Aloë Formula F-BC-096 in the Treatment of Split Thickness Donor Sites After Wound Closure
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT00389753 |
Recruitment Status :
Suspended
(study never started)
First Posted : October 19, 2006
Last Update Posted : September 29, 2010
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Hydration of Scars | Drug: Application of Aruba Aloë formula F-BC-096 or control | Not Applicable |
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 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 |

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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 3 Years to 75 Years (Child, Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00389753
Belgium | |
University Hospital Ghent | |
Ghent, Belgium, 9000 |
Principal Investigator: | Stan Monstrey, MD, PhD | University Hospital, Ghent |
Responsible Party: | Stan Monstrey, University Hospital Ghent |
ClinicalTrials.gov Identifier: | NCT00389753 |
Other Study ID Numbers: |
2006/326 |
First Posted: | October 19, 2006 Key Record Dates |
Last Update Posted: | September 29, 2010 |
Last Verified: | September 2010 |
Scars Hydratation After Treatment |