An Open Randomized Comparative Trial of Four Different Dressings for Cutaneous Coverage in Pemphigus and Pemphigoid
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Enrollment
- 12
- Locations
- 2
- Primary Endpoint
- Wound Healing Percentage of a 64 cm2 area of epithelialized skin
Study Overview
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 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Diagnosis of pemphigus vulgaris, pemphigus foliaceus , pemphigus vegetans, paraneoplastic pemphigus or bullous pemphigoid
- •At least four areas of active disease in the trunk or limbs of 8 x 8 cm characterized by denudation, ulceration, scabs or blisters.
- •Capable of being evaluated weekly either as outpatient or hospitalized
- •Actively treated with immunosuppressive or immunomodulatory drugs for pemphigus or pemphigoid control
- •Willing to sign an informed consent
Exclusion Criteria
- •Patients with hypersensitivity to any of the components of the skin dressings that will be used.
- •Patients who have participated in any clinical trial in the last 30 days.
Arms & Interventions
Cotton gauze with petrolatum
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.
Intervention: Cotton gauze with petrolatum (Device)
Cellulose acetate 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).
Intervention: Cellulose acetate with petrolatum (Device)
Nanocrystalline silver
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.
Intervention: Nanocrystalline silver (Acticoat) (Device)
Carboxymethylcellulose with ionic silver
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.
Intervention: Carboxymethylcellulose with ionic silver (Aquacel Ag) (Device)
Outcomes
Primary Outcomes
Wound Healing Percentage of a 64 cm2 area of epithelialized skin
Time Frame: 42 days
Percentage of a 64 cm2 area of epithelialized skin
Secondary Outcomes
- Itch Using the visual analog scale a decrease in itch score(42 days)
- Pain Using the visual analog scale a decrease in pain score(42 days)
Investigators
Jose Contreras-Ruiz
Head of the Interdisciplinary Wound and Ostomy Care Center. Division of Dermatology.
Hospital General Dr. Manuel Gea González