Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Wound Dressings for Pemphigus and Pemphigoid

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02365675
Recruitment Status : Unknown
Verified September 2014 by Jose Contreras-Ruiz, Hospital General Dr. Manuel Gea González.
Recruitment status was:  Recruiting
First Posted : February 19, 2015
Last Update Posted : February 19, 2015
Sponsor:
Collaborator:
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
Information provided by (Responsible Party):
Jose Contreras-Ruiz, Hospital General Dr. Manuel Gea González

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.

Condition or disease Intervention/treatment Phase
Pemphigus Pemphigoid Device: Cotton gauze with petrolatum Device: Cellulose acetate with petrolatum Device: Nanocrystalline silver (Acticoat) Device: Carboxymethylcellulose with ionic silver (Aquacel Ag) Not Applicable

  Show Detailed Description

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 12 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: An Open Randomized Comparative Trial of Four Different Dressings for Cutaneous Coverage in Pemphigus and Pemphigoid
Study Start Date : January 2015
Estimated Primary Completion Date : January 2016
Estimated Study Completion Date : June 2016

Resource links provided by the National Library of Medicine

Drug Information available for: Petrolatum

Arm Intervention/treatment
Active Comparator: 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.
Device: Cotton gauze with petrolatum
Active Comparator: 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).
Device: Cellulose acetate with petrolatum
Other Name: Curity non-adhering dressing

Active Comparator: 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.
Device: Nanocrystalline silver (Acticoat)
Other Name: Acticoat

Active Comparator: 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.
Device: Carboxymethylcellulose with ionic silver (Aquacel Ag)
Other Name: Aquacel Ag




Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. Pain Using the visual analog scale a decrease in pain score [ Time Frame: 42 days ]
    Using the visual analog scale a decrease in pain score

  2. Itch Using the visual analog scale a decrease in itch score [ Time Frame: 42 days ]
    Using the visual analog scale a decrease in itch score



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02365675


Contacts
Layout table for location contacts
Contact: Jose Contreras-Ruiz, MD +525540003000 ext 3502 dermayheridas@gmail.com
Contact: Karla Lopez-Ortiz, MD +5215585583329 karlitaav24@hotmail.com

Locations
Layout table for location information
Mexico
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran Recruiting
Mexico, DF, Mexico, 14000
Contact: Judith Dominguez-Cherit, MD    +525554870900 ext 4586    judom59@hotmail.com   
Contact: Rodrigo Cepeda, MD    +525554870900 ext 4586    dr.rcepeda@gmail.com   
Hospital General Dr Manuel Gea González Recruiting
Mexico, DF, Mexico, 14080
Contact: Jose Contreras-Ruiz, MD    +525540003000 ext 3502    dermayheridas@gmail.com   
Contact: Karla Lopez-Ortiz, MD    +5215585583329    karlitaav24@hotmail.com   
Sponsors and Collaborators
Fundación Nacional para la Enseñanza y la Investigación de la Dermatología A.C.
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
Investigators
Layout table for investigator information
Principal Investigator: Jose Contreras-Ruiz, MD Hospital General Dr Manuel Gea Gonzalez

Publications:

Layout table for additonal information
Responsible Party: Jose Contreras-Ruiz, Head of the Interdisciplinary Wound and Ostomy Care Center. Division of Dermatology., Hospital General Dr. Manuel Gea González
ClinicalTrials.gov Identifier: NCT02365675     History of Changes
Other Study ID Numbers: 06-106-2014
First Posted: February 19, 2015    Key Record Dates
Last Update Posted: February 19, 2015
Last Verified: September 2014
Keywords provided by Jose Contreras-Ruiz, Hospital General Dr. Manuel Gea González:
Pemphigus
Pemphigoid
Wound Healing
Itch
Pain
Wound dressing
Topical treatment
Additional relevant MeSH terms:
Layout table for MeSH terms
Pemphigus
Pemphigoid, Bullous
Skin Diseases, Vesiculobullous
Skin Diseases
Autoimmune Diseases
Immune System Diseases
Petrolatum
Carboxymethylcellulose Sodium
Laxatives
Gastrointestinal Agents
Emollients
Dermatologic Agents