WoundsPhase 4NCT01213420

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

A Phase 4 study testing Nivea Cream for scar hydration, Aloë Vera FORMULA F-BC-096 for scar hydration and Eucerin Calming cream for scar hydration in people with Wounds, run by University Hospital, Ghent at 3 sites in Belgium.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

This study is a prospective, randomized controlled, double blinded, study in a multi centre setting. Three burn centres will include 60 patients in total. If suited for the study (= two equal donor sites) and after informed consent, patients will be observed starting the day of skin prelevation. Read more about this study

Who is it for?: Any age
Conditions the study is for: Wounds
What is being tested?: Nivea Cream for scar hydration, Aloë Vera FORMULA F-BC-096 for scar hydration and Eucerin Calming cream for scar hydration
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 60 participants
Where: 3 sitesBelgium
Study dates: Jan 2010to Sep 2011
Phase: Phase 4
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 Any age
All sexes
No healthy volunteers
Child, Adult, Older adult

Who may be able to join

Patients must have two similar donor sites regarding location, depth and wound treatment.
Healing time of both donor sites may differ by 5 days maximum.
Patient compliance with therapy in relation to the protocol is necessary. In case of paediatric patients this depends on the 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. Pressure garments and/or silicone sheets are used only in case of burn wounds within the same location.
Patients must be available for regular and necessary follow-up (up to 6 months post healing).
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).
The patient has a known allergy to Aloe Vera and/or to preservatives in cosmetic products.
The patient is not able to follow the complete treatment schedule.
The patient has any condition(s) that seriously compromises the patient's ability to complete this study.
The occurrence of a traumatic wound over the healed donor site (e.g. abrasion, skin tear, …)
The patient wishes to terminate the study.
No informed consent before start of the trial.

Trial locations and contacts

3 sites in 1 country.

Belgium3 sites

Hospital Network Antwerp
Antwerp
University Hospital Ghent
Ghent
Military Hospital
Neder-Over-Heembeek

Other trials in Belgium

About this study

Official title: A Prospective, Randomized Controlled, Double Blinded, Clinical Multicentre Trial of the Aruba Aloe Formula F-BC-096 in the Treatment of Split Thickness Donor Sites After Wound Closure

This study is a prospective, randomized controlled, double blinded, study in a multi centre setting. Three burn centres will include 60 patients in total.

If suited for the study (= two equal donor sites) and after informed consent, patients will be observed starting the day of skin prelevation.

A coded file will be made for each patient and these files should contain the localization of both donor sites, their depth as determined by the setting of the dermatome and the treatment. Treatment for both donor sites will always be equal.

The date of wound healing of each donor site, which may only differ by a maximum of five days, will be noted. Digital photographs of the healed donor sites will be taken and the scars will be evaluated by the local researchers using the Adapted Vancouver Scar Scale prior to the start of hydration.

From that moment on one donor site will be treated with Aruba Aloe formula F-BC-096 while one of the control products will be applied to the second site. Per group of five patients per centre a different control product will be applied to the second donor site. The tubes containing these products will be colour and numerical coded. Nor the treating personnel, nor the patients will be informed which colour tubes contain the control products and which contain the Aruba Aloe formula F-BC-096. If it is necessary to apply pressure garments for one donor site, the garments will be applied for both sites.

Follow-Ups will be performed on one, three and six months after wound closure. Objective methods will be used during these follow-ups to evaluate elasticity and colour of the scar, this by using the Dermalab, the Cutometer®, the Derma Spectrometer and the Mexameter®. The evaporation, permeability and hydration of the scar will be measured by using the Tewameter® and the Corneometer®. The Reviscometer® will measure the direction of collagen and elastin. The Adapted Vancouver Scar Scale will be used as a subjective method. Also different scales for evaluation of donor site pain, patient satisfaction, product comfort, itching etc. have to be completed by the patient.

Conditions: Wounds
Being tested: Nivea Cream for scar hydration, Aloë Vera FORMULA F-BC-096 for scar hydration, Eucerin Calming cream for scar hydration, Aloë Vera with modified preservative for scar hydration
Keywords: Donor sites after wound closure
Medical subject headings: Wounds and Injuries

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Nivea Cream for scar hydrationOther
3 applications per day during 6 months
Aloë Vera FORMULA F-BC-096 for scar hydrationOther
3 applications per day during 6 months.
Eucerin Calming cream for scar hydrationOther
3 applications per day during 6 months
Aloë Vera with modified preservative for scar hydrationOther
3 applications per day during 6 months

Study groups in NCT01213420
Study group	Role	What they receive
Aloë Vera FORMULA F-BC-096	Experimental	Not described Receives: Other: Aloë Vera FORMULA F-BC-096 for scar hydration
Aloë Vera FORMULA F-BC-096 with modified preservative	Active comparator	Not described Receives: Other: Aloë Vera with modified preservative for scar hydration
Eucerin Calming cream	Active comparator	Not described Receives: Other: Eucerin Calming cream for scar hydration
Nivea Cream	Active comparator	Not described Receives: Other: Nivea Cream for scar hydration

What is being measured

The primary outcome is the main question the study is designed to answer.

improvement in patients treated with Aruba Aloe Formula F-BC-096 compared to patients treated with the three comparators
- The adapted Vancouver Scar Scale (1, 3 and 6 months after wound closure)
- Measurement of the Trans Epidermal Water Loss with the Tewameter (1, 3 and 6 months after wound closure)
- Measurement of the hydration of the stratum corneum with the Corneometer (1, 3 and 6 months after wound closure)
Measured: after 6 months of scar hydration

Secondary outcomes (5)

improvement of overall scar quality in patients treated with Aruba Aloe Formula F-BC-096 compared to patients treated with the three comparators:
Measured: after 6 months of scar hydration
improvement of overall product satisfaction in patients treated with Aruba Aloe Formula F-BC-096 compared to patients treated with the three comparators
Measured: after 6 months of scar hydration
improvement of scar colour in patients treated with Aruba Aloe Formula F-BC-096 compared to patients treated with the three comparators
Measured: after 6 months of scar hydration
improvement of scar elasticity in patients treated with Aruba Aloe Formula F-BC-096 compared to patients treated with the three comparators
Measured: after 6 months of scar hydration
improvement of collagen and elastin direction in patients treated with Aruba Aloe Formula F-BC-096 compared to patients treated with the three comparators
Measured: after 6 months of scar hydration

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jan 2010Sep 2011

First posted4 Oct 2010 (estimated)
Study startJan 2010
Primary completionJan 2011
Study completionSep 2011

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for WoundsStudies 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 4
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 60 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01213420
Sponsor's protocol ID: 2009/567
Status last verified: Jun 2012
First submitted: 30 Sep 2010
Last updated: 14 Jun 2012
Results posted: No
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 14 Jun 2012. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Prospective, Randomized Controlled, Double Blinded, Clinical Multicentre Trial of the Aruba Aloe Formula F-BC-096 in the Treatment of Split Thickness Donor Sites After Wound Closure
ClinicalTrials.gov ID: NCT01213420
Acronym / sponsor ID: 2009/567
Conditions: Wounds
Keywords: Donor sites after wound closure
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 60 participants (actual)
Lead sponsor: University Hospital, GhentUniversity, hospital or other
Collaborators: Belgian Foundation for Burn Injuries, Belgium
Study start: Jan 2010
Primary completion: Jan 2011 (actual)
Study completion: Sep 2011 (actual)
First posted: 4 Oct 2010 (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.

This study is a prospective, randomized controlled, double blinded, study in a multi centre setting. Three burn centres will include 60 patients in total.

If suited for the study (= two equal donor sites) and after informed consent, patients will be observed starting the day of skin prelevation.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 4

Arm	Type	Receives
Aloë Vera FORMULA F-BC-096	Experimental	Other: Aloë Vera FORMULA F-BC-096 for scar hydration
Aloë Vera FORMULA F-BC-096 with modified preservative	Active comparator	Other: Aloë Vera with modified preservative for scar hydration
Eucerin Calming cream	Active comparator	Other: Eucerin Calming cream for scar hydration
Nivea Cream	Active comparator	Other: Nivea Cream for scar hydration

Who may qualify

Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult

Key inclusion criteria (7 listed)

Patients must have two similar donor sites regarding location, depth and wound treatment.
Healing time of both donor sites may differ by 5 days maximum.
Patient compliance with therapy in relation to the protocol is necessary. In case of paediatric patients this depends on the 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. Pressure garments and/or silicone sheets are used only in case of burn wounds within the same location.
Patients must be available for regular and necessary follow-up (up to 6 months post healing).

Key exclusion criteria (7 listed)

Donor sites are not similar (not identical in: depth, wound treatment, healing time).
The patient has a known allergy to Aloe Vera and/or to preservatives in cosmetic products.
The patient is not able to follow the complete treatment schedule.
The patient has any condition(s) that seriously compromises the patient's ability to complete this study.
The occurrence of a traumatic wound over the healed donor site (e.g. abrasion, skin tear, …)

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
Nivea Cream for scar hydration3 applications per day during 6 months	Other	Nivea Cream
Aloë Vera FORMULA F-BC-096 for scar hydration3 applications per day during 6 months.	Other	Aloë Vera FORMULA F-BC-096
Eucerin Calming cream for scar hydration3 applications per day during 6 months	Other	Eucerin Calming cream
Aloë Vera with modified preservative for scar hydration3 applications per day during 6 months	Other	Aloë Vera FORMULA F-BC-096 with modified preservative

Primary outcome

improvement in patients treated with Aruba Aloe Formula F-BC-096 compared to patients treated with the three comparators
Time frame: after 6 months of scar hydration
* The adapted Vancouver Scar Scale (1, 3 and 6 months after wound closure) * Measurement of the Trans Epidermal Water Loss with the Tewameter (1, 3 and 6 months after wound closure) * Measurement of the hydration of the stratum corneum with the Corneometer (1, 3 and 6 months after wound closure)

5 secondary outcomes

improvement of overall scar quality in patients treated with Aruba Aloe Formula F-BC-096 compared to patients treated with the three comparators:
Time frame: after 6 months of scar hydration
improvement of overall product satisfaction in patients treated with Aruba Aloe Formula F-BC-096 compared to patients treated with the three comparators
Time frame: after 6 months of scar hydration
improvement of scar colour in patients treated with Aruba Aloe Formula F-BC-096 compared to patients treated with the three comparators
Time frame: after 6 months of scar hydration
improvement of scar elasticity in patients treated with Aruba Aloe Formula F-BC-096 compared to patients treated with the three comparators
Time frame: after 6 months of scar hydration
improvement of collagen and elastin direction in patients treated with Aruba Aloe Formula F-BC-096 compared to patients treated with the three comparators
Time frame: after 6 months of scar hydration

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 14 Jun 2012.
website University Hospital Ghent, BelgiumLink provided by the sponsor.

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Enrolling by invitation
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Recruiting
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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, Belgium

3 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 7 inclusion and 7 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: finished, as of the sponsor's last update on 14 Jun 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites 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.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

improvement in patients treated with Aruba Aloe Formula F-BC-096 compared to patients treated with the three comparators (time frame: after 6 months of scar hydration). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01213420.

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 14 Jun 2012.