Occlusion vs Standard Treatment for the Treatment of Herpes Zoster
NCT ID: NCT04258930
Last Updated: 2020-02-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
36 participants
INTERVENTIONAL
2020-02-26
2022-01-31
Brief Summary
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Detailed Description
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In this clinical trial the investigators believe that given this information, using occlusive therapy with a hydrocolloid dressing or a silicone-based gel may heal the rash of herpes zoster, decrease pain and improve the quality of life, much faster than the treatment currently used of drying the area with powders and solutions.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Group A: Aluminum sulphate and calcium acetate drying soaks
Group A will receive 10 minute soaks every 8 hours with a solution prepared with aluminum sulphate and calcium acetate powder (Domeboro® (Advaita Pharmaceuticals, México)) diluted in 500 ml of clean cold water.
Aluminum sulphate and calcium acetate drying soaks
Dilute one envelope of the powder in 500 ml of clean cold water and apply for 10 minutes every 8 hours until completely healed.
Group B: Topical sterile silicone gel for wounds
Group B will receive topical silicone sterile gel for wounds (Stratamed gel®, (Stratapharma, Switzerland)) applied every 8 hours.
Topical sterile silicone gel for wounds
Apply a thick layer of silicone gel to all open areas every 8 hours until completely healed.
Group C: Hydrocolloid dressing
Group C will apply an extra thin hydrocolloid dressing to all the open areas (Duoderm Extra Thin® (Convatec, USA)) with dressing changes every 48 to 72 hours depending on the amount of wound exudate.
Hydrocolloid dressing
Apply enough hydrocolloid dressings to cover all open areas and change every 2 to 3 days once the dressing becomes saturated (starts to drain around the borders).
Interventions
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Aluminum sulphate and calcium acetate drying soaks
Dilute one envelope of the powder in 500 ml of clean cold water and apply for 10 minutes every 8 hours until completely healed.
Topical sterile silicone gel for wounds
Apply a thick layer of silicone gel to all open areas every 8 hours until completely healed.
Hydrocolloid dressing
Apply enough hydrocolloid dressings to cover all open areas and change every 2 to 3 days once the dressing becomes saturated (starts to drain around the borders).
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Patients having maximum 72 hours from the start of the first vesicle
* Older than 18 years
Exclusion Criteria
* Patients with hydrocolloid allergy
* Patients with acetaminophen allergy
* Patients with aluminium sulphate and calcium acetate allergy
* Patients with acyclovir allergy
* Pregnant women
* Breastfeeding women
* Unable to give informed consent
* Patients with signs of infection over the skin rash
* Patients with disseminated HZ
* Patients with hemorrhagic HZ
* Patients with complications such as pneumonia or encephalitis
* Patients unable to apply the treatment to the affected area
* Patients with HZ-associated keratitis
* Patients whose rash is located to hairy areas that may hinder occlusion with the hydrocolloid dressing.
18 Years
ALL
No
Sponsors
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Fundación Nacional para la Enseñanza y la Investigación de la Dermatología A.C.
OTHER
Responsible Party
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Principal Investigators
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Jose Contreras-Ruiz, MD
Role: PRINCIPAL_INVESTIGATOR
Fundación Nacional para la Enseñanza y la Investigación de la Dermatología A.C.
Locations
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Hospital General Dr Manuel Gea González
Mexico City, Mexico City, Mexico
Countries
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Central Contacts
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Facility Contacts
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Jose Contreras-Ruiz, MD
Role: primary
Adriana Lozano-Platonoff, MD
Role: backup
References
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Boivin G, Jovey R, Elliott CT, Patrick DM. Management and prevention of herpes zoster: A Canadian perspective. Can J Infect Dis Med Microbiol. 2010 Spring;21(1):45-52. doi: 10.1155/2010/178036.
Bader MS. Herpes zoster: diagnostic, therapeutic, and preventive approaches. Postgrad Med. 2013 Sep;125(5):78-91. doi: 10.3810/pgm.2013.09.2703.
Cohen JI. Clinical practice: Herpes zoster. N Engl J Med. 2013 Jul 18;369(3):255-63. doi: 10.1056/NEJMcp1302674.
Coplan PM, Schmader K, Nikas A, Chan IS, Choo P, Levin MJ, Johnson G, Bauer M, Williams HM, Kaplan KM, Guess HA, Oxman MN. Development of a measure of the burden of pain due to herpes zoster and postherpetic neuralgia for prevention trials: adaptation of the brief pain inventory. J Pain. 2004 Aug;5(6):344-56. doi: 10.1016/j.jpain.2004.06.001.
Finlay AY, Khan GK. Dermatology Life Quality Index (DLQI)--a simple practical measure for routine clinical use. Clin Exp Dermatol. 1994 May;19(3):210-6. doi: 10.1111/j.1365-2230.1994.tb01167.x.
Greenwood JE, Wagstaff MJ, Mackie IP, Mustoe TA. Silicone action in the open wound: a hypothesis. J Burn Care Res. 2012 Jan-Feb;33(1):e17-20. doi: 10.1097/BCR.0b013e31823e68cc. No abstract available.
HINMAN CD, MAIBACH H. EFFECT OF AIR EXPOSURE AND OCCLUSION ON EXPERIMENTAL HUMAN SKIN WOUNDS. Nature. 1963 Oct 26;200:377-8. doi: 10.1038/200377a0. No abstract available.
Karlsmark T, Goodman JJ, Drouault Y, Lufrano L, Pledger GW; Cold Sore Study Group. Randomized clinical study comparing Compeed cold sore patch to acyclovir cream 5% in the treatment of herpes simplex labialis. J Eur Acad Dermatol Venereol. 2008 Nov;22(10):1184-92. doi: 10.1111/j.1468-3083.2008.02761.x. Epub 2008 May 6.
Keegan DA. Reducing pain in acute herpes zoster with plain occlusive dressings: a case report. J Med Case Rep. 2015 Apr 25;9:89. doi: 10.1186/s13256-015-0560-5.
Lin PL, Fan SZ, Huang CH, Huang HH, Tsai MC, Lin CJ, Sun WZ. Analgesic effect of lidocaine patch 5% in the treatment of acute herpes zoster: a double-blind and vehicle-controlled study. Reg Anesth Pain Med. 2008 Jul-Aug;33(4):320-5. doi: 10.1016/j.rapm.2007.02.015.
Monk EC, Benedetto EA, Benedetto AV. Successful treatment of nonhealing scalp wounds using a silicone gel. Dermatol Surg. 2014 Jan;40(1):76-9. doi: 10.1111/dsu.12366. Epub 2013 Nov 25. No abstract available.
O'Brien L, Jones DJ. Silicone gel sheeting for preventing and treating hypertrophic and keloid scars. Cochrane Database Syst Rev. 2013 Sep 12;2013(9):CD003826. doi: 10.1002/14651858.CD003826.pub3.
Patel AR, Romanelli P, Roberts B, Kirsner RS. Treatment of herpes simplex virus infection: rationale for occlusion. Adv Skin Wound Care. 2007 Jul;20(7):408-12. doi: 10.1097/01.ASW.0000280199.58260.62.
Patel AR, Romanelli P, Roberts B, Kirsner RS. Herpes simplex virus: a histopathologic study of the depth of herpetic wounds. Int J Dermatol. 2009 Jan;48(1):36-40. doi: 10.1111/j.1365-4632.2009.03788.x.
Pott FS, Meier MJ, Stocco JG, Crozeta K, Ribas JD. The effectiveness of hydrocolloid dressings versus other dressings in the healing of pressure ulcers in adults and older adults: a systematic review and meta-analysis. Rev Lat Am Enfermagem. 2014 May-Jun;22(3):511-20. doi: 10.1590/0104-1169.3480.2445.
Tsai TF, Yao CA, Yu HS, Lan CC, Chao SC, Yang JH, Yang KC, Chen CY, White RR, Psaradellis E, Rampakakis E, Kawai K, Acosta CJ, Sampalis JS. Herpes zoster-associated severity and duration of pain, health-related quality of life, and healthcare utilization in Taiwan: a prospective observational study. Int J Dermatol. 2015;54(5):529-36. doi: 10.1111/ijd.12484. Epub 2014 Sep 10.
Uva L, Aphale AN, Kehdy J, Benedetto AV. Erosive pustular dermatosis successfully treated with a novel silicone gel. Int J Dermatol. 2016 Jan;55(1):89-91. doi: 10.1111/ijd.13066. Epub 2015 Sep 4. No abstract available.
WINTER GD. Formation of the scab and the rate of epithelization of superficial wounds in the skin of the young domestic pig. Nature. 1962 Jan 20;193:293-4. doi: 10.1038/193293a0. No abstract available.
Strauss SE, Oxman NM. Varicella and Herpes Zoster. In: Freedberg IM, Eisen AZ, Wolff K, Kopff A, et al. editors. Fitzpatrick´s dermatology in general medicine. New York, McGraw-Hill 1999, pp 2427-49.
Other Identifiers
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FNEIDAC-HZ-122-19
Identifier Type: -
Identifier Source: org_study_id