Trial record 2 of 4 for:    ARUBA

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

This study has been completed.
Sponsor:
Collaborator:
Belgian Foundation for Burn Injuries, Belgium
Information provided by (Responsible Party):
University Hospital, Ghent
ClinicalTrials.gov Identifier:
NCT01213420
First received: September 30, 2010
Last updated: June 13, 2012
Last verified: June 2012
  Purpose

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.


Condition Intervention Phase
Wounds
Other: Nivea Cream for scar hydration
Other: Aloë Vera FORMULA F-BC-096 for scar hydration
Other: Eucerin Calming cream for scar hydration
Other: Aloë Vera with modified preservative for scar hydration
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by University Hospital, Ghent:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    • 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)


Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

Enrollment: 60
Study Start Date: January 2010
Study Completion Date: September 2011
Primary Completion Date: January 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Aloë Vera FORMULA F-BC-096 Other: Aloë Vera FORMULA F-BC-096 for scar hydration
3 applications per day during 6 months.
Active Comparator: Aloë Vera FORMULA F-BC-096 with modified preservative Other: Aloë Vera with modified preservative for scar hydration
3 applications per day during 6 months
Active Comparator: Eucerin Calming cream Other: Eucerin Calming cream for scar hydration
3 applications per day during 6 months
Active Comparator: Nivea Cream Other: Nivea Cream for scar hydration
3 applications per day during 6 months

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.
  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: NCT01213420

Locations
Belgium
Hospital Network Antwerp
Antwerp, Belgium
University Hospital Ghent
Ghent, Belgium
Military Hospital
Neder-Over-Heembeek, Belgium
Sponsors and Collaborators
University Hospital, Ghent
Belgian Foundation for Burn Injuries, Belgium
Investigators
Principal Investigator: Stan Monstrey, MD, PhD University Hospital Ghent, Belgium
  More Information

Additional Information:
No publications provided

Responsible Party: University Hospital, Ghent
ClinicalTrials.gov Identifier: NCT01213420     History of Changes
Other Study ID Numbers: 2009/567
Study First Received: September 30, 2010
Last Updated: June 13, 2012
Health Authority: Belgium: Ethics Committee

Keywords provided by University Hospital, Ghent:
Donor sites after wound closure

ClinicalTrials.gov processed this record on September 15, 2014