Aruba Aloë Formula F-BC-096 in the Treatment of Split Thi... | NCT00389753

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

NCT00389753

Sponsor

University Hospital, Ghent

Status

Withdrawn

Last Update Posted

Jul 2, 2021Actual

Enrollment

0Actual

Phase

Not Applicable

Conditions

Hydration of Scars

Interventions

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

Countries

Belgium

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2021

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

study never started

Expanded Access Info

Start Date

Not provided

Primary Completion Date

Not provided

Completion Date

Not provided

First Submitted Date

Oct 18, 2006

First Submission Date that Met QC Criteria

Oct 18, 2006

First Posted Date

Oct 19, 2006Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 1, 2021

Last Update Posted Date

Jul 2, 2021Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Name	Type	Description	Arm Group Labels	Other Names
Application of Aruba Aloë formula F-BC-096 or control	Drug

Measure	Description	Time Frame
Scar assessment after 1 month

Measure	Description	Time Frame
Scar assessment 3, 6 and 12 months after wound closure

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

3 Years

Maximum Age

75 Years

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

ID	Term
D005355	Fibrosis
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms