Pilot Study to Evaluate Clinical Outcomes With the Use of Biovance Following Keloid Scar Revision Surgery
Status unconfirmed · Phase 4
Conditions studied: Keloid Scar
In brief
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.
Key facts
- Study ID
- NCT02521402
- Run by
- Golla Center for Plastic Surgery
- People needed
- 10
- Starts
- 2015-08-01
- Expected to finish
- 2017-06-01
- Last updated by the study team
- 2015-08-13
Who can join
Age: 21 and older, up to 80. Sex: any. Healthy volunteers: not accepted.
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
Where it is running
- Golla Center for Plastic Surgery — Pittsburgh, Pennsylvania, United States
Full record on ClinicalTrials.gov
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