Pilot Study to Evaluate Clinical Outcomes With the Use of Biovance Following Keloid Scar Revision Surgery

NCT02521402 | Unknown Phase 4

• 1 other identifier: Golla-01-Keloid
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

The main purpose of this study is to see if there is clinical benefit of using Biovance in reduction of the recurrence of keloids when used to revise them. It will also assess the postoperative complications.

Conditions

Keloid Scar

Outcome Measures

Primary Outcomes (1)

• Incidence of keloid scar recurrence after revision surgery with placement of Biovance

  Published data in the literature reporting on keloid scar incidence and recurrence without the use of Biovance may serve as a reference/historical control.

  1 year post-surgery

Secondary Outcomes (2)

• Clinical outcomes of keloid scar revision surgery, including scar size and appearance

  1 year post-surgery

• Incidence of complications (including infection, incision dehiscence, hematoma, seroma, and wound necrosis following revision surgery

  1 year post-surgery

Study Arms (1)

Keloid Revision Surgery with Biovance

OTHER

All enrolled patients will have Biovance applied during Keloid Revision Surgery

Biological: Biovance

Interventions

Biovance BIOLOGICAL

decellularized, dehydrated human amniotic membrane

Keloid Revision Surgery with Biovance

Eligibility Criteria

• Age: 21 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• The subject has:
• been diagnosed with a keloid scar
• a keloid scar that is located on the face, neck, arm, trunk, or groin area
• is between the ages of 21 and 80 years old
• competency as an adult, per applicable state law who is willing to provide written informed consent
• the intent and ability to return for all scheduled and required visits and follow recommended standard post surgical treatment for keloid scar excision.

You may not qualify if:

• The subject has:
• clinical evidence of infection of the keloid scar
• any malignancy or a neoplasm at the keloid scar site
• 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 \[including systemic lupus erythematosis (SLE), rheumatoid arthritis (RA),fibromyalgia, polymyositis, scleroderma, ankylosing spondylitis, dermatomyositis, osteogenesis imperfecta or the inherited disorders of Sjogren, Larsen, Raynaud, Ehlers-Danlos or Marfan syndrome\]
• received chemotherapy, radiotherapy, immunosuppressives or corticosteroids (greater than 10 mg prednisone-equivalent per day) within the past 30 days.
• 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
• condition(s) that would adversely affect subject safety by following the protocol
• any contraindication for use of Biovance

Sponsors & Collaborators

• Golla Center for Plastic Surgery: lead

Study Sites (1)

Golla Center for Plastic Surgery

Pittsburgh, Pennsylvania, 15236, United States

Location

Related Publications (7)

• 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.

  PMID: 17644502 RESULT

• 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.

  PMID: 20927486 RESULT

• 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.

  PMID: 24527306 RESULT

• 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.

  PMID: 5352921 RESULT

• 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.

  PMID: 15140214 RESULT

• 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.

  PMID: 15365369 RESULT

• 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.

  PMID: 26061491 RESULT

MeSH Terms

Conditions

Keloid

Condition Hierarchy (Ancestors)

Collagen Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Cicatrix; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Dinakar Golla, MD

  Golla Center for Plastic Surgery

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dinakar Golla, MD

CONTACT

412-963-6677; drgolla@gollaplasticsurgery.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 10, 2015
• First Posted: August 13, 2015
• Study Start: August 1, 2015
• Primary Completion: December 1, 2016
• Study Completion: June 1, 2017
• Last Updated: August 13, 2015

Record last verified: 2015-08

Locations

US (1)