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WithdrawnNCT00389753Updated Jul 2, 2021

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

An interventional study of Application of Aruba Aloë formula F-BC-096 or control in Hydration of Scars, sponsored by University Hospital, Ghent. Withdrawn at 1 site in Belgium. Open to participants aged 3 Years to 75 Years. Per ClinicalTrials.gov, last updated 2021-07-02.

Sponsored by University Hospital, Ghent · Not applicable, Interventional, and Treatment

Why this study was withdrawn
study never started
Phase
Not applicable
Study type
Interventional
Enrollment
0
Allocation
Randomized
Ages
3 Years to 75 Years
Sex
All
01

Study summary

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

Read the 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.

02

Conditions studied

  • Hydration of Scars

Keywords

  • Scars
  • Hydratation
  • After Treatment
03

In context

Lead sponsor

University Hospital, Ghent is the lead sponsor of 665 studies on the registry; 156 are open to participants now.

Of its 5 completed or terminated interventional studies of FDA-regulated products, 4 (80%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
3 Years to 75 Years
Sexes eligible
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

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Single group
Masking
Double
Enrollment
0 participants (actual)

Interventions

  • DrugApplication of Aruba Aloë formula F-BC-096 or control
06

What researchers measure

Primary outcomes

  1. Scar assessment after 1 month

Secondary outcomes

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

07

Study locations

1 site
  • University Hospital Ghent
    Ghent, 9000, Belgium
08

References and documents

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 2, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00389753
Lead sponsor
University Hospital, Ghent
Responsible party
Sponsor
First posted
Oct 19, 2006
Last update
Jul 2, 2021

Study contacts

Stan Monstrey, MD, PhD
principal investigator · University Hospital, Ghent

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is withdrawn, as verified in Jul 2021. You cannot join it, but the record below documents what was studied.

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