Ignite Creation Date:
2024-05-06 @ 3:45 AM
Last Modification Date:
2024-10-26 @ 11:38 AM
Study NCT ID:
NCT02365675
Status:
UNKNOWN
Last Update Posted:
2015-02-19
First Post:
2015-02-11
Brief Title:
Wound Dressings for Pemphigus and Pemphigoid
Sponsor:
Fundación Nacional para la Enseñanza y la Investigación de la Dermatología AC
Organization:
Fundación Nacional para la Enseñanza y la Investigación de la Dermatología AC
Study Overview
Official Title:
An Open Randomized Comparative Trial of Four Different Dressings for Cutaneous Coverage in Pemphigus and Pemphigoid
Status:
UNKNOWN
Status Verified Date:
2014-09
Last Known Status:
RECRUITING
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:
The purpose of this study is to compare the efficacy of four dressings covers namely gauze with petrolatum cellulose acetate with petrolatum pure carboxymethylcellulose with silver and nanocrystalline silver to improve the new growth of skin reduce pain and itch in persons suffering from pemphigus and pemphigoid
Detailed Description:
Pemphigus and pemphigoid are the most frequently autoinmune bullous diseases seen in dermatology Despite all the treatments that have been studied for the management of bullous skin diseases there is insufficient information about the best skin dressing or cover that can be used in affected or denuded areas in these conditions
Therefore we will compare the efficacy of four different covers gauze with petrolatum cellulose acetate with petrolatum pure carboxymethylcellulose with silver and nanocrystalline silver in providing faster healing and decreasing pain and itch
Each patient with the diagnosis of either pemphigus or pemphigoid will have a full skin examination and 4 of the most affected areas will be randomly assigned to receive each of the 4 treatments previously described
There is no clinical study focused specifically on the materials that will be used in this study There are few isolated cases reported that can not be taken as a basis Considering the above and based on the clinical experience we consider it appropriate to conduct a pilot study with a total of 10-14 patients with it we will perform a sample calculation considering a potential alpha error of 005 yielding the beta error by subtracting 10 to the power sample calculated
In all of the patients 4 affected areas of 8 cm x 8 cm 64 cm2 will be selected and marked with the letters A B C and D The investigator will generate randomization tables where previously established and numbered treatments 1 to 4 will be randomly assigned to each of the four areas Thus all patients will receive the 4 therapies but randomly in the 4 areas previously selected
The variables that will be studied are
Total area affected Consists of the sum of the percentages of skin that is not healthy in the 64 cm2
Intensity of pain sensory unpleasant emotional experience that occurs from the potential or actual injury tissue Will be assessed by visual analog scale validated method
Erythema Inflammation of the skin surface caused by excess blood supply causing redness
Itch cutaneous unpleasant sensation and of variable intensity that causes an urge to scratch to get relief Will be assessed by visual analog scale validated method
Healing Reparing process of an altered tissue resulting in the formation of a scar tissue Will be measured based on the reduction of wound area percentage It shall be measured in cm2 with ImageJ program ImageJ US National Institutes of Health Bethesda Maryland USA http imagejnihgovij
Ulcer injury depressed by loss of epidermis dermis and subcutaneous tissue They will be measured in total area in cm2 by ImageJ program
Blisters pustules or vesicles are elemental skin lesions with a liquid content ranging from light to heavy white They will be measured in total area in cm2 by ImageJ program
Procedure description
Day 0
The patient will be evaluated to determine if is eligible according to the selection criteria
The protocol will be explained in clear words so that the patient understands it
The patient will have to sign the informed consent
Total body surface area will be revalutatd to select the 4 most severely affected areas in the trunk or limbs of 8 cm x 8 cm each and that will be assigned with a letter from A to D
With an indelible marker the 4 vertices of each of the previously selected areas will be marked
A label graduated in millimeters will be placed at the bottom edge of the marked areas
A panoramic picture of each of the four areas will be taken to ensure that if the label is lost we can replicate it in the next visit
An aproach picture of each of these four areas will be taken
The selected areas will be cleaned with sterile saline
Clinical evaluation will be performed and the section of the report format will be filled
The envelope containing randomization numbers will be opened to decide which dressing skin cover will be used to each of the selected areas
The dressings covers will be placed on each of the selected areas Above it conventional gauze will be placed and this cure will be pinned up with conventional elastic white band
The patient will recieve the appointments of the 6 subsequent valorations
The patient will recive the prescription for the systemic management of the bullous skin disease
The patient will receive a second prescription explaining how he should be healing between each visit If it is an inpatient the healing and measurement will be performed by the medical personnel assigned The family will be explained how to perform the healing and at the end of his hospital stay a prescription will be given with the instructions Also the next control appointment will be given
Pictures will be downloaded and the presence of abnormal skin will be measured using a standardized measurement program ImageJ US NationalInstitutes of Health Bethesda Maryland USA httpimagejnihgovij All data obtained will be registered in the report format made specifically for this trial
Subsequent visits 7 14 21 28 35
The presence of systemic or local adverse effects at any of the 4 areas of study will be asked
The 4 areas will be discovered using saline and gently drying The healling and the further steps are the same as the ones explained above
All the data obtained will be recorded on the report format
Final visit day 42
The patient will be told he or she is no more in the protocol and which of the dressings worked the best
The patient will receive his or her next appoinment
A prescription with the systemic treatment will be given
A second prescription will be given explaining how to perform the healings
All data obtained will be recorded to the further results analysis
Results will be presented as percentages or proportions for categorical variables and by mean standard deviation for continuous variables The percentage of epithelialization between the four groups will be compared with Chi Square RxC Continuous numerical variables will be compared with one way ANOVA in the case of homoscedastic variances or by Kruskall Wallis variance in the case of heteroskedastic variances The results will be adjusted in relation to the received systemic treatment duration intensity the location of the lesions and its chronicity with multivariate lienal regression analysis For bivariate anaysis a significant value of p 005 will be used For multivariate analysis a p 010 value will be used STATA version 130 for Mac wiil be used
Tables and grapfhs will be used to present the results
Therefore we will compare the efficacy of four different covers gauze with petrolatum cellulose acetate with petrolatum pure carboxymethylcellulose with silver and nanocrystalline silver in providing faster healing and decreasing pain and itch
Each patient with the diagnosis of either pemphigus or pemphigoid will have a full skin examination and 4 of the most affected areas will be randomly assigned to receive each of the 4 treatments previously described
There is no clinical study focused specifically on the materials that will be used in this study There are few isolated cases reported that can not be taken as a basis Considering the above and based on the clinical experience we consider it appropriate to conduct a pilot study with a total of 10-14 patients with it we will perform a sample calculation considering a potential alpha error of 005 yielding the beta error by subtracting 10 to the power sample calculated
In all of the patients 4 affected areas of 8 cm x 8 cm 64 cm2 will be selected and marked with the letters A B C and D The investigator will generate randomization tables where previously established and numbered treatments 1 to 4 will be randomly assigned to each of the four areas Thus all patients will receive the 4 therapies but randomly in the 4 areas previously selected
The variables that will be studied are
Total area affected Consists of the sum of the percentages of skin that is not healthy in the 64 cm2
Intensity of pain sensory unpleasant emotional experience that occurs from the potential or actual injury tissue Will be assessed by visual analog scale validated method
Erythema Inflammation of the skin surface caused by excess blood supply causing redness
Itch cutaneous unpleasant sensation and of variable intensity that causes an urge to scratch to get relief Will be assessed by visual analog scale validated method
Healing Reparing process of an altered tissue resulting in the formation of a scar tissue Will be measured based on the reduction of wound area percentage It shall be measured in cm2 with ImageJ program ImageJ US National Institutes of Health Bethesda Maryland USA http imagejnihgovij
Ulcer injury depressed by loss of epidermis dermis and subcutaneous tissue They will be measured in total area in cm2 by ImageJ program
Blisters pustules or vesicles are elemental skin lesions with a liquid content ranging from light to heavy white They will be measured in total area in cm2 by ImageJ program
Procedure description
Day 0
The patient will be evaluated to determine if is eligible according to the selection criteria
The protocol will be explained in clear words so that the patient understands it
The patient will have to sign the informed consent
Total body surface area will be revalutatd to select the 4 most severely affected areas in the trunk or limbs of 8 cm x 8 cm each and that will be assigned with a letter from A to D
With an indelible marker the 4 vertices of each of the previously selected areas will be marked
A label graduated in millimeters will be placed at the bottom edge of the marked areas
A panoramic picture of each of the four areas will be taken to ensure that if the label is lost we can replicate it in the next visit
An aproach picture of each of these four areas will be taken
The selected areas will be cleaned with sterile saline
Clinical evaluation will be performed and the section of the report format will be filled
The envelope containing randomization numbers will be opened to decide which dressing skin cover will be used to each of the selected areas
The dressings covers will be placed on each of the selected areas Above it conventional gauze will be placed and this cure will be pinned up with conventional elastic white band
The patient will recieve the appointments of the 6 subsequent valorations
The patient will recive the prescription for the systemic management of the bullous skin disease
The patient will receive a second prescription explaining how he should be healing between each visit If it is an inpatient the healing and measurement will be performed by the medical personnel assigned The family will be explained how to perform the healing and at the end of his hospital stay a prescription will be given with the instructions Also the next control appointment will be given
Pictures will be downloaded and the presence of abnormal skin will be measured using a standardized measurement program ImageJ US NationalInstitutes of Health Bethesda Maryland USA httpimagejnihgovij All data obtained will be registered in the report format made specifically for this trial
Subsequent visits 7 14 21 28 35
The presence of systemic or local adverse effects at any of the 4 areas of study will be asked
The 4 areas will be discovered using saline and gently drying The healling and the further steps are the same as the ones explained above
All the data obtained will be recorded on the report format
Final visit day 42
The patient will be told he or she is no more in the protocol and which of the dressings worked the best
The patient will receive his or her next appoinment
A prescription with the systemic treatment will be given
A second prescription will be given explaining how to perform the healings
All data obtained will be recorded to the further results analysis
Results will be presented as percentages or proportions for categorical variables and by mean standard deviation for continuous variables The percentage of epithelialization between the four groups will be compared with Chi Square RxC Continuous numerical variables will be compared with one way ANOVA in the case of homoscedastic variances or by Kruskall Wallis variance in the case of heteroskedastic variances The results will be adjusted in relation to the received systemic treatment duration intensity the location of the lesions and its chronicity with multivariate lienal regression analysis For bivariate anaysis a significant value of p 005 will be used For multivariate analysis a p 010 value will be used STATA version 130 for Mac wiil be used
Tables and grapfhs will be used to present the results
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