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

History of Changes

Tracking Information

First Received Date ^ICMJE

October 18, 2006

Last Updated Date

September 28, 2010

Start Date ^ICMJE

Not Provided

Primary Completion Date

Not Provided

Current Primary Outcome Measures ^ICMJE

Scar assessment after 1 month

Original Primary Outcome Measures ^ICMJE

Wound closure

Change History

Complete list of historical versions of study NCT00389753 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Scar assessment 3, 6 and 12 months after wound closure

Original Secondary Outcome Measures ^ICMJE

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

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

Brief Summary

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

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.

Study Type ^ICMJE

Interventional

Study Phase

Not Provided

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double-Blind
Primary Purpose: Treatment

Condition ^ICMJE

Hydration of Scars

Intervention ^ICMJE

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

Study Arm (s)

Not Provided

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Suspended

Estimated Enrollment ^ICMJE

Completion Date

Not Provided

Primary Completion Date

Not Provided

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

3 Years to 75 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Belgium

Administrative Information

NCT Number ^ICMJE

NCT00389753

Other Study ID Numbers ^ICMJE

2006/326

Has Data Monitoring Committee

Responsible Party

Stan Monstrey, University Hospital Ghent

Study Sponsor ^ICMJE

University Hospital, Ghent

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Stan Monstrey, MD, PhD

University Hospital, Ghent

Information Provided By

University Hospital, Ghent

Verification Date

September 2010

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

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