An interventional study of Cotton gauze with petrolatum and Cellulose acetate with petrolatum in Pemphigus and Pemphigoid, sponsored by Fundación Nacional para la Enseñanza y la Investigación de la Dermatología A.C.. Status unknown at 2 sites in Mexico. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2015-02-19.
Sponsored by Fundación Nacional para la Enseñanza y la Investigación de la Dermatología A.C. · Not applicable, Interventional, and Treatment
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.
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 0.05, yielding the beta error by subtracting 1.0 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:
Procedure description:
Day 0
Subsequent visits ( 7, 14, 21 , 28, 35 )
Final visit (day 42)
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 \< 0.05 will be used. For multivariate analysis a p \< 0.10 value will be used. STATA version 13.0 for Mac wiil be used.
Tables and grapfhs will be used to present the results.
73 studies on the registry are indexed under Pemphigoid, Bullous; 11 are open to participants now.
This study's planned enrollment of 12 is below the median of 29 across 43 interventional studies indexed under Pemphigoid, Bullous.
Browse Pemphigoid, Bullous studies →Fundación Nacional para la Enseñanza y la Investigación de la Dermatología A.C. is the lead sponsor of 3 studies on the registry; none are open to participants now.
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Exclusion Criteria:
The dressing to be used is regular cotton gauze impregnated in petrolatum (a mixture of solid hydrocarbons) creating a film that reduces the adherence of the gauze to the wound.
Device: Cotton gauze with petrolatum
The dressing to be used is a mesh or tulle base of cellulose acetate polymers that do not easily adhere to the wound impregnated in petrolatum (a mixture of solid hydrocarbons).
Device: Cellulose acetate with petrolatum
The dressing to be used consists of two layers of a silver-coated, high-density polyethylene mesh, enclosing a single layer of an apertured non-woven fabric of rayon and polyester. The three components are ultrasonically welded together to maintain the integrity of the dressing in use. Silver is applied to the polyethylene mesh by a vapour deposition process, which results in the formation of microscopic 'nanocrystals' of metallic silver.
Device: Nanocrystalline silver (Acticoat)
The dressing to be used is a soft, sterile, non- woven pad dressing made from sodium carboxymethylcellulose containing 1.2% silver in an ionic form.
Device: Carboxymethylcellulose with ionic silver (Aquacel Ag)
Also known as: Curity non-adhering dressing
Also known as: Acticoat
Also known as: Aquacel Ag
Wound Healing Percentage of a 64 cm2 area of epithelialized skin
Percentage of a 64 cm2 area of epithelialized skin
Time frame: 42 days
Pain Using the visual analog scale a decrease in pain score
Using the visual analog scale a decrease in pain score
Time frame: 42 days
Itch Using the visual analog scale a decrease in itch score
Using the visual analog scale a decrease in itch score
Time frame: 42 days
This study is status unknown, as verified in Sep 2014. You cannot join it, but the record below documents what was studied.
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Fundación Nacional para la Enseñanza y la Investigación de la Dermatología A.C.