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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
  Purpose

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


Condition Intervention
Hydration of Scars
Drug: Application of Aruba Aloë formula F-BC-096 or control

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double-Blind
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

Resource links provided by NLM:


Further study details as provided by University Hospital, Ghent:

Primary Outcome Measures:
  • Scar assessment after 1 month

Secondary Outcome Measures:
  • Scar assessment 3, 6 and 12 months after wound closure

Estimated Enrollment: 25
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.

  Eligibility

Ages Eligible for Study:   3 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00389753

Locations
Belgium
University Hospital Ghent
Ghent, Belgium, 9000
Sponsors and Collaborators
University Hospital, Ghent
Investigators
Principal Investigator: Stan Monstrey, MD, PhD University Hospital, Ghent
  More Information

Additional Information:
No publications provided

Responsible Party: Stan Monstrey, University Hospital Ghent
ClinicalTrials.gov Identifier: NCT00389753     History of Changes
Other Study ID Numbers: 2006/326
Study First Received: October 18, 2006
Last Updated: September 28, 2010
Health Authority: Belgium: Institutional Review Board

Keywords provided by University Hospital, Ghent:
Scars
Hydratation
After Treatment

ClinicalTrials.gov processed this record on November 25, 2014