Wound Dressings for Pemphigus and Pemphigoid

NCT02365675 | Unknown

• 1 other identifier: 06-106-2014
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 2

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.

Conditions

Pemphigus; Pemphigoid

Keywords

Pemphigus; Pemphigoid; Wound Healing; Itch; Pain; Wound dressing; Topical treatment

Outcome Measures

Primary Outcomes (1)

• Wound Healing Percentage of a 64 cm2 area of epithelialized skin

  Percentage of a 64 cm2 area of epithelialized skin

  42 days

Secondary Outcomes (2)

• Pain Using the visual analog scale a decrease in pain score

  42 days

• Itch Using the visual analog scale a decrease in itch score

  42 days

Study Arms (4)

Cotton gauze with petrolatum

ACTIVE COMPARATOR

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

Cellulose acetate with petrolatum

ACTIVE COMPARATOR

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

Nanocrystalline silver

ACTIVE COMPARATOR

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)

Carboxymethylcellulose with ionic silver

ACTIVE COMPARATOR

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)

Interventions

Cotton gauze with petrolatum DEVICE

Cotton gauze with petrolatum

Cellulose acetate with petrolatum DEVICE

Also known as: Curity non-adhering dressing

Cellulose acetate with petrolatum

Nanocrystalline silver (Acticoat) DEVICE

Also known as: Acticoat

Nanocrystalline silver

Carboxymethylcellulose with ionic silver (Aquacel Ag) DEVICE

Also known as: Aquacel Ag

Carboxymethylcellulose with ionic silver

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fundación Nacional para la Enseñanza y la Investigación de la Dermatología A.C.: lead
• Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran: collaborator

Study Sites (2)

Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

Mexico City, Mexico City, 14000, Mexico

RECRUITING

Hospital General Dr Manuel Gea González

Mexico City, Mexico City, 14080, Mexico

RECRUITING

Related Publications (20)

• Amagai M. Preface to Journal of Dermatology special issue: pemphigus updates from around the world. J Dermatol. 2015 Jan;42(1):2. doi: 10.1111/1346-8138.12774. No abstract available.

  PMID: 25558945 BACKGROUND

• Mimouni D, Anhalt GJ, Lazarova Z, Aho S, Kazerounian S, Kouba DJ, Mascaro JM Jr, Nousari HC. Paraneoplastic pemphigus in children and adolescents. Br J Dermatol. 2002 Oct;147(4):725-32. doi: 10.1046/j.1365-2133.2002.04992.x.

  PMID: 12366419 BACKGROUND

• Mutasim DF. Autoimmune bullous dermatoses in the elderly: an update on pathophysiology, diagnosis and management. Drugs Aging. 2010 Jan 1;27(1):1-19. doi: 10.2165/11318600-000000000-00000.

  PMID: 20030429 BACKGROUND

• Kirtschig G, Khumalo NP. Management of bullous pemphigoid: recommendations for immunomodulatory treatments. Am J Clin Dermatol. 2004;5(5):319-26. doi: 10.2165/00128071-200405050-00005.

  PMID: 15554733 BACKGROUND

• Martin LK, Werth V, Villanueva E, Segall J, Murrell DF. Interventions for pemphigus vulgaris and pemphigus foliaceus. Cochrane Database Syst Rev. 2009 Jan 21;(1):CD006263. doi: 10.1002/14651858.CD006263.pub2.

  PMID: 19160272 BACKGROUND

• Joly P, Roujeau JC, Benichou J, Delaporte E, D'Incan M, Dreno B, Bedane C, Sparsa A, Gorin I, Picard C, Tancrede-Bohin E, Sassolas B, Lok C, Guillaume JC, Doutre MS, Richard MA, Caux F, Prost C, Plantin P, Chosidow O, Pauwels C, Maillard H, Saiag P, Descamps V, Chevrant-Breton J, Dereure O, Hellot MF, Esteve E, Bernard P. A comparison of two regimens of topical corticosteroids in the treatment of patients with bullous pemphigoid: a multicenter randomized study. J Invest Dermatol. 2009 Jul;129(7):1681-7. doi: 10.1038/jid.2008.412. Epub 2009 Jan 29.

  PMID: 19177141 BACKGROUND

• Wojnarowska F, Kirtschig G, Highet AS, Venning VA, Khumalo NP; British Association of Dermatologists. Guidelines for the management of bullous pemphigoid. Br J Dermatol. 2002 Aug;147(2):214-21. doi: 10.1046/j.1365-2133.2002.04835.x.

  PMID: 12174090 BACKGROUND

• Khumalo NP, Murrell DF, Wojnarowska F, Kirtschig G. A systematic review of treatments for bullous pemphigoid. Arch Dermatol. 2002 Mar;138(3):385-9. doi: 10.1001/archderm.138.3.385.

  PMID: 11902990 BACKGROUND

• Kirtschig G, Middleton P, Bennett C, Murrell DF, Wojnarowska F, Khumalo NP. Interventions for bullous pemphigoid. Cochrane Database Syst Rev. 2010 Oct 6;2010(10):CD002292. doi: 10.1002/14651858.CD002292.pub3.

  PMID: 20927731 BACKGROUND

• Dressler DP, Skornik WA. Burn wound dressings. II. Effect on wound sepsis. J Trauma. 1971 Apr;11(4):325-30. No abstract available.

  PMID: 5551730 BACKGROUND

• Sibbald RG, Contreras-Ruiz J, Coutts P, Fierheller M, Rothman A, Woo K. Bacteriology, inflammation, and healing: a study of nanocrystalline silver dressings in chronic venous leg ulcers. Adv Skin Wound Care. 2007 Oct;20(10):549-58. doi: 10.1097/01.ASW.0000294757.05049.85.

  PMID: 17906429 BACKGROUND

• Gravante G, Caruso R, Sorge R, Nicoli F, Gentile P, Cervelli V. Nanocrystalline silver: a systematic review of randomized trials conducted on burned patients and an evidence-based assessment of potential advantages over older silver formulations. Ann Plast Surg. 2009 Aug;63(2):201-5. doi: 10.1097/SAP.0b013e3181893825.

  PMID: 19571738 BACKGROUND

• Asz J, Asz D, Moushey R, Seigel J, Mallory SB, Foglia RP. Treatment of toxic epidermal necrolysis in a pediatric patient with a nanocrystalline silver dressing. J Pediatr Surg. 2006 Dec;41(12):e9-12. doi: 10.1016/j.jpedsurg.2006.08.043.

  PMID: 17161178 BACKGROUND

• Chen J, Han CM, Lin XW, Tang ZJ, Su SJ. [Effect of silver nanoparticle dressing on second degree burn wound]. Zhonghua Wai Ke Za Zhi. 2006 Jan 1;44(1):50-2. Chinese.

  PMID: 16620649 BACKGROUND

• Murrell DF, Daniel BS, Joly P, Borradori L, Amagai M, Hashimoto T, Caux F, Marinovic B, Sinha AA, Hertl M, Bernard P, Sirois D, Cianchini G, Fairley JA, Jonkman MF, Pandya AG, Rubenstein D, Zillikens D, Payne AS, Woodley D, Zambruno G, Aoki V, Pincelli C, Diaz L, Hall RP, Meurer M, Mascaro JM Jr, Schmidt E, Shimizu H, Zone J, Swerlick R, Mimouni D, Culton D, Lipozencic J, Bince B, Grando SA, Bystryn JC, Werth VP. Definitions and outcome measures for bullous pemphigoid: recommendations by an international panel of experts. J Am Acad Dermatol. 2012 Mar;66(3):479-85. doi: 10.1016/j.jaad.2011.06.032. Epub 2011 Nov 5.

  PMID: 22056920 BACKGROUND

• Daroczy J, Szalai I. [Use of polyurethane foil for wound covering]. Orv Hetil. 1991 Jun 2;132(22):1203-4. Hungarian.

  PMID: 2067830 BACKGROUND

• Patange VS, Fernandez RJ, Motla MU, Mahajan SA. Dressing wounds with potato peel. Indian J Dermatol Venereol Leprol. 1996 Sep-Oct;62(5):286-8.

  PMID: 20948091 BACKGROUND

• Dumas V, Roujeau JC, Wolkenstein P, Revuz J, Cosnes A. The treatment of mild pemphigus vulgaris and pemphigus foliaceus with a topical corticosteroid. Br J Dermatol. 1999 Jun;140(6):1127-9. doi: 10.1046/j.1365-2133.1999.02895.x.

  PMID: 10354082 BACKGROUND

• Grando SA. New approaches to the treatment of pemphigus. J Investig Dermatol Symp Proc. 2004 Jan;9(1):84-91. doi: 10.1111/j.1087-0024.2004.00826.x.

  PMID: 14870992 BACKGROUND

• Vun YY, Lun K, Strutton G. Use of biosynthetic dressings in paraneoplastic pemphigus. Australas J Dermatol. 2004 May;45(2):133-5. doi: 10.1111/j.1440-0960.2004.00067.x.

  PMID: 15068464 BACKGROUND

MeSH Terms

Conditions

Pemphigus; Pemphigoid, Bullous; Pruritus; Pain

Condition Hierarchy (Ancestors)

Skin Diseases, Vesiculobullous; Skin Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases; Skin Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurologic Manifestations

Study Officials

• Jose Contreras-Ruiz, MD

  Hospital General Dr Manuel Gea Gonzalez

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jose Contreras-Ruiz, MD

CONTACT

+525540003000; dermayheridas@gmail.com

Karla Lopez-Ortiz, MD

CONTACT

+5215585583329; karlitaav24@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of the Interdisciplinary Wound and Ostomy Care Center. Division of Dermatology.

Study Record Dates

• First Submitted: February 11, 2015
• First Posted: February 19, 2015
• Study Start: January 1, 2015
• Primary Completion: January 1, 2016
• Study Completion: June 1, 2016
• Last Updated: February 19, 2015

Record last verified: 2014-09

Locations

ME (2)