Hydration of ScarsNCT00389753
Aruba Aloë Formula F-BC-096 in the Treatment of Split Thickness Donor Sites After Wound Closure
A study of Hydration of Scars, run by University Hospital, Ghent at 1 site in Belgium.
Trial summary
Comparison between use of Aruba Aloë formula F-BC-096 and control. Read more about this study
- Who is it for?
- Ages 3 to 75 years
- Conditions the study is for
- Hydration of Scars
- How many people
- 0 participants
- Where
- 1 siteBelgium
- Study dates
- Start not givento not given
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 75 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Show all 9Show fewer
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
- Conditions
- Hydration of Scars
- Being tested
- Application of Aruba Aloë formula F-BC-096 or control
- Keywords
- Scars, Hydratation, After Treatment
- Medical subject headings
- Cicatrix
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Application of Aruba Aloë formula F-BC-096 or controlDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Scar assessment after 1 month
Secondary outcomes (1)
Scar assessment 3, 6 and 12 months after wound closure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2006 (estimated)
Why it stopped: study never started
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hydration of ScarsStudies of the same condition, open and under way.
- More trials run by University Hospital, GhentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Ghent
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Stan Monstrey, MD, PhD, Principal investigator, University Hospital, Ghent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00389753
- Sponsor's protocol ID
- 2006/326
- Status last verified
- Jul 2021
- First submitted
- 18 Oct 2006
- Last updated
- 2 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00389753
- Acronym / sponsor ID
- 2006/326
- Conditions
- Hydration of Scars
- Keywords
- Scars, Hydratation, After Treatment
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: study never started
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University Hospital, GhentUniversity, hospital or other
- First posted
- 19 Oct 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
Who may qualify
- Ages
- 3 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (9 listed)
- 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.
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Application of Aruba Aloë formula F-BC-096 or control | Drug | – |
Primary outcome
Scar assessment after 1 month
1 secondary outcome
Scar assessment 3, 6 and 12 months after wound closure
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2021.
- Website of the University Hospital GhentLink provided by the sponsor.
Related trials for Hydration of Scars
RecruitingObservational study
Validation of the Use of Terahertz Scanning System on Corneal Scars and Corneal Edema
Corneal Diseases, Corneal Scars and Opacities
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stan Monstrey, MD, PhD principal investigator
University Hospital, Ghent
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of Hydration of Scars, run by University Hospital, Ghent at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 2 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Scar assessment after 1 month. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jul 2021.