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

NCT01213420 | Completed Phase 4

• 1 other identifier: 2009/567
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 3

Brief 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. 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

Keywords

Donor sites after wound closure

Outcome Measures

Primary Outcomes (1)

• 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)

  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:

  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

  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

  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

  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

  after 6 months of scar hydration

Study Arms (4)

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

Interventions

Nivea Cream for scar hydration OTHER

3 applications per day during 6 months

Nivea Cream

Aloë Vera FORMULA F-BC-096 for scar hydration OTHER

3 applications per day during 6 months.

Aloë Vera FORMULA F-BC-096

Eucerin Calming cream for scar hydration OTHER

3 applications per day during 6 months

Eucerin Calming cream

Aloë Vera with modified preservative for scar hydration OTHER

3 applications per day during 6 months

Aloë Vera FORMULA F-BC-096 with modified preservative

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Hospital, Ghent: lead
• Belgian Foundation for Burn Injuries, Belgium: collaborator

Study Sites (3)

Hospital Network Antwerp

Antwerp, Belgium

Location

University Hospital Ghent

Ghent, Belgium

Location

Military Hospital

Neder-Over-Heembeek, Belgium

Location

Related Links

• website University Hospital Ghent, Belgium

MeSH Terms

Conditions

Wounds and Injuries

Study Officials

• Stan Monstrey, MD, PhD

  University Hospital Ghent, Belgium

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 30, 2010
• First Posted: October 4, 2010
• Study Start: January 1, 2010
• Primary Completion: January 1, 2011
• Study Completion: September 1, 2011
• Last Updated: June 14, 2012

Record last verified: 2012-06

Locations

BE (3)