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

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. Identifier: NCT02521402
Recruitment Status : Unknown
Verified August 2015 by Golla Center for Plastic Surgery.
Recruitment status was:  Not yet recruiting
First Posted : August 13, 2015
Last Update Posted : August 13, 2015
Information provided by (Responsible Party):
Golla Center for Plastic Surgery

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.

Condition or disease Intervention/treatment Phase
Keloid Scar Biological: Biovance Phase 4

Detailed Description:

To assess the performance of Biovance, patients will consulted regarding the history and previous treatment of their keloid. Once patients are deemed to be appropriate candidates, they will be enrolled in the study. Operatively, the old scar will be completely excised. Then the Biovance will be laid in the base of the wound. After this is performed, extensive undermining will be done to close the wound in layers.

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Pilot Study to Evaluate Clinical Outcomes With the Use of Biovance, a Dehydrated Decellularized Human Amnion Membrane Allograft, Following Keloid Revision Surgery
Study Start Date : August 2015
Estimated Primary Completion Date : December 2016
Estimated Study Completion Date : June 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Scars

Arm Intervention/treatment
Keloid Revision Surgery with Biovance
All enrolled patients will have Biovance applied during Keloid Revision Surgery
Biological: Biovance
decellularized, dehydrated human amniotic membrane

Primary Outcome Measures :
  1. Incidence of keloid scar recurrence after revision surgery with placement of Biovance [ Time Frame: 1 year post-surgery ]
    Published data in the literature reporting on keloid scar incidence and recurrence without the use of Biovance may serve as a reference/historical control.

Secondary Outcome Measures :
  1. Clinical outcomes of keloid scar revision surgery, including scar size and appearance [ Time Frame: 1 year post-surgery ]
  2. Incidence of complications (including infection, incision dehiscence, hematoma, seroma, and wound necrosis following revision surgery [ Time Frame: 1 year post-surgery ]

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.

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Ages Eligible for Study:   21 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

The subject has:

  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:

The subject has:

  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

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 identifier (NCT number): NCT02521402

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Contact: Dinakar Golla, MD 412-963-6677

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United States, Pennsylvania
Golla Center for Plastic Surgery Not yet recruiting
Pittsburgh, Pennsylvania, United States, 15236
Contact: Dinakar Golla, MD    412-963-6677   
Sponsors and Collaborators
Golla Center for Plastic Surgery
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Principal Investigator: Dinakar Golla, MD Golla Center for Plastic Surgery

Publications of Results:
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Responsible Party: Golla Center for Plastic Surgery Identifier: NCT02521402     History of Changes
Other Study ID Numbers: Golla-01-Keloid
First Posted: August 13, 2015    Key Record Dates
Last Update Posted: August 13, 2015
Last Verified: August 2015

Additional relevant MeSH terms:
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Collagen Diseases
Connective Tissue Diseases
Pathologic Processes