Ignite Creation Date:
2024-05-05 @ 10:54 PM
Last Modification Date:
2024-10-26 @ 10:25 AM
Study NCT ID:
NCT01213420
Status:
COMPLETED
Last Update Posted:
2012-06-14
First Post:
2010-09-30
Brief Title:
Aruba Aloe Formula F-BC-096 in the Treatment of Split Thickness Donor Site After Wound Closure
Sponsor:
University Hospital Ghent
Organization:
University Hospital Ghent
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2012-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None