Pilot Study to Evaluate Clinical Outcomes With the Use of Biovance Following Keloid Scar Revision Surgery
NCT ID: NCT02521402
Last Updated: 2015-08-13
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
PHASE4
10 participants
INTERVENTIONAL
2015-08-31
2017-06-30
Brief Summary
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Detailed Description
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All post-revision complications (including infection, incision dehiscence, hematoma, seroma, and wound necrosis) will be assessed and recorded by the investigator. Patients will be reviewed to obtain demographic and risk factor (such as age, body mass index, smoking) data. Data on adjuvant therapy use (previous surgeries, treatments for keloid scar) will be collected. Surgical technique details (such as incision size and closure technique) will also be recorded for each patient. Photographs documenting the pre-, intra- and post-revision clinical course of patients will be collected.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Keloid Revision Surgery with Biovance
All enrolled patients will have Biovance applied during Keloid Revision Surgery
Biovance
decellularized, dehydrated human amniotic membrane
Interventions
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Biovance
decellularized, dehydrated human amniotic membrane
Eligibility Criteria
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Inclusion Criteria
1. been diagnosed with a keloid scar
2. a keloid scar that is located on the face, neck, arm, trunk, or groin area
3. is between the ages of 21 and 80 years old
4. competency as an adult, per applicable state law who is willing to provide written informed consent
5. the intent and ability to return for all scheduled and required visits and follow recommended standard post surgical treatment for keloid scar excision.
Exclusion Criteria
1. clinical evidence of infection of the keloid scar
2. any malignancy or a neoplasm at the keloid scar site
3. any significant comorbid disease that may interfere with wound healing, known active Hepatitis A, B, or C or Acquired Immune Deficiency Syndrome or is known to be infected with HIV, a known collagen disorder or autoimmune disease \[including systemic lupus erythematosis (SLE), rheumatoid arthritis (RA),fibromyalgia, polymyositis, scleroderma, ankylosing spondylitis, dermatomyositis, osteogenesis imperfecta or the inherited disorders of Sjogren, Larsen, Raynaud, Ehlers-Danlos or Marfan syndrome\]
4. received chemotherapy, radiotherapy, immunosuppressives or corticosteroids (greater than 10 mg prednisone-equivalent per day) within the past 30 days.
5. a known history of abuse of alcohol or drugs (prescribed or illegal), significant psychiatric personality or psychotic disorder requiring chronic psychotropic therapy, or gross noncompliance to recommended therapies
6. condition(s) that would adversely affect subject safety by following the protocol
7. any contraindication for use of Biovance
21 Years
80 Years
ALL
No
Sponsors
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Golla Center for Plastic Surgery
OTHER
Responsible Party
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Principal Investigators
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Dinakar Golla, MD
Role: PRINCIPAL_INVESTIGATOR
Golla Center for Plastic Surgery
Locations
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Golla Center for Plastic Surgery
Pittsburgh, Pennsylvania, United States
Countries
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Central Contacts
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Facility Contacts
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References
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Durani P, Bayat A. Levels of evidence for the treatment of keloid disease. J Plast Reconstr Aesthet Surg. 2008;61(1):4-17. doi: 10.1016/j.bjps.2007.05.007. Epub 2007 Jul 19.
Gauglitz GG, Korting HC, Pavicic T, Ruzicka T, Jeschke MG. Hypertrophic scarring and keloids: pathomechanisms and current and emerging treatment strategies. Mol Med. 2011 Jan-Feb;17(1-2):113-25. doi: 10.2119/molmed.2009.00153. Epub 2010 Oct 5.
Viera MH, Vivas AC, Berman B. Update on Keloid Management: Clinical and Basic Science Advances. Adv Wound Care (New Rochelle). 2012 Oct;1(5):200-206. doi: 10.1089/wound.2011.0313.
Alhady SM, Sivanantharajah K. Keloids in various races. A review of 175 cases. Plast Reconstr Surg. 1969 Dec;44(6):564-6. doi: 10.1097/00006534-196912000-00006. No abstract available.
Marneros AG, Norris JE, Watanabe S, Reichenberger E, Olsen BR. Genome scans provide evidence for keloid susceptibility loci on chromosomes 2q23 and 7p11. J Invest Dermatol. 2004 May;122(5):1126-32. doi: 10.1111/j.0022-202X.2004.22327.x.
Lee JY, Yang CC, Chao SC, Wong TW. Histopathological differential diagnosis of keloid and hypertrophic scar. Am J Dermatopathol. 2004 Oct;26(5):379-84. doi: 10.1097/00000372-200410000-00006.
Smiell JM, Treadwell T, Hahn HD, Hermans MH. Real-world Experience With a Decellularized Dehydrated Human Amniotic Membrane Allograft. Wounds. 2015 Jun;27(6):158-69.
Other Identifiers
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Golla-01-Keloid
Identifier Type: -
Identifier Source: org_study_id
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